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Reported trial results for Rheumatoid Arthritis

Every Rheumatoid Arthritis trial Voxsanity tracks that has reported results to a public registry, newest first. These trials have finished, so they are not recruiting. Not medical advice.

234 trials have reported results.

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

  • NCT03915964 · results posted 24 June 2026

    According to the results reported on ClinicalTrials.gov, this trial (part of a larger program also involving a companion study, NCT04086745) enrolled 886 people in the baricitinib 2 mg group, 886 in the baricitinib 4 mg group, and 887 in the TNF inhibitor (an existing class of arthritis medicine used for comparison) group — roughly 2,659 participants in total at the start. The trial was designed to measure how long it took for participants to experience certain serious medical events — including blood clots in veins (venous thromboembolism), blood clots in arteries, major heart or stroke events, new cancers (excluding a common type of skin cancer), and serious infections — when taking baricitinib compared to a TNF inhibitor. Notably, the final results were analysed by pooling data from this trial together with the companion study, giving a combined analysis set of over 3,600 participants across the groups. The reported data shows that for every single outcome measure — both the primary outcome (time to a vein blood clot event, comparing combined baricitinib doses to TNF inhibitor) and all secondary outcomes (individual dose comparisons, artery clot events, heart/stroke events, cancers, and serious infections) — the recorded values are listed as "NA," meaning the numerical results were not reported in the data submitted to ClinicalTrials.gov. This applies across all treatment groups. Because the actual hazard ratio figures (a way of comparing how often an event happened in one group versus another over time) were not provided in the submission, it is not possible to describe what the numbers showed. The reported data also shows that fewer than half of participants in each group completed the study — around 433–428 in the baricitinib groups and 415 in the TNF inhibitor group — though the reasons for non-completion are not detailed in this data extract. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03247023 · results posted 22 June 2026

    According to the results reported on ClinicalTrials.gov, this trial enrolled 61 adults who received the Integra® Cadence™ Total Ankle System, an ankle replacement implant. The trial was measuring how long the implant lasted without needing to be removed or replaced, as well as tracking participants' self-reported mobility, ability to carry out daily activities, and ankle pain levels over time. The reported data shows that none of the 61 participants were recorded as having formally "completed" the study under the trial's own milestone definitions, though outcome data was still submitted. The reported data shows that at the two-year mark, 100% of participants still had their implant in place without it needing to be removed or revised. A longer-term survivorship figure of 94.12% was also reported, calculated using a statistical method (called a Kaplan-Meier estimate) that tracks how many implants remain in place over time — this figure covered the five- and ten-year follow-up period combined. For self-reported mobility (scored 0–100, where higher is better), scores appear to have risen from 41.5 before the procedure to figures in the mid-to-upper 70s at later time points, before sitting at 68.6 at the final recorded time point. Daily activity ability scores (also 0–100, higher is better) followed a similar pattern, starting at 48.4 and reaching the low-to-mid 80s before settling at 79.5. Pain scores while resting (0–100, where higher means more pain) started at 42.5 before the procedure and were reported as low as 6.3 at one later time point, ending at 13.3. Pain during activity started at 73.1 and was reported at 26.1 at the final time point. Note that the specific time points for each of these scores were not clearly labelled in the data submitted, so the exact timing of each measurement cannot be confirmed here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03905525 · results posted 18 May 2026

    According to the results reported on ClinicalTrials.gov, this trial (NCT03905525) enrolled 273 adults with Sjögren's syndrome — a condition that affects moisture-producing glands — across two groups (called cohorts). Cohort 1 included 173 participants and tested three different doses of a medicine called CFZ533 (150 mg, 300 mg, and 600 mg) against a placebo (a dummy treatment with no active ingredient). Cohort 2 included 100 participants and compared CFZ533 600 mg against placebo. The trial ran in two phases of 24 weeks each (48 weeks total). The main things being measured were a doctor-assessed disease activity score (called ESSDAI, on a scale of 0–123 where higher means more active disease) for Cohort 1, and a patient-reported symptom score covering pain, fatigue, and dryness (called ESSPRI, on a scale of 0–10 where higher means worse symptoms) for Cohort 2. The reported data shows that in Cohort 1 at 24 weeks, ESSDAI scores fell from baseline by an average of 4.0 points in the placebo group, 7.0 points in the 150 mg CFZ533 group, 5.4 points in the 300 mg group, and 6.9 points in the 600 mg group (lower scores indicate less disease activity). For Cohort 2 at 24 weeks, the ESSPRI symptom score fell by an average of 1.21 points in the placebo group and 1.79 points in the CFZ533 600 mg group. The reported data also shows results for several secondary measures at 24 weeks in Cohort 1: the patient-reported symptom score (ESSPRI) fell by 1.3 points (placebo), 1.8 points (150 mg), 1.6 points (300 mg), and 1.8 points (600 mg). A fatigue questionnaire (scored 0–52, where higher means less fatigue) improved by 7.0 points (placebo), 8.6 points (150 mg), 8.0 points (300 mg), and 10.3 points (600 mg). A doctor's overall rating of disease activity (on a 0–100 scale) fell by 23.9 points (placebo), 31.6 points (150 mg), 30.8 points (300 mg), and 27.0 points (600 mg). In Cohort 2, the fatigue questionnaire score improved by 5.7 points (placebo) and 7.3 points (CFZ533 600 mg). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT05576012 · results posted 8 January 2026

    According to the results reported on ClinicalTrials.gov, this trial (NCT05576012) enrolled 56 participants in total, split across seven active-treatment groups (called Cohorts 1–7, with 6 participants each) and three placebo groups (10 participants in the placebo group for Cohorts 1–5, and 2 participants each in the placebo groups for Cohorts 6 and 7). Most participants received a single dose of the investigational treatment, while Cohort 6 received multiple doses. The trial was primarily measuring a range of safety-related outcomes, including the number of adverse events (unexpected or unwanted medical occurrences), injection site reactions, abnormal blood or lab test results, immune reactions, heart trace (ECG) abnormalities, and unusual body temperature readings. The reported data shows that across all groups, no clinically significant abnormalities were recorded for lab tests, immune reactions, heart traces, or body temperature. For general adverse events — which include any medical occurrence noticed during the trial, whether or not thought to be related to the treatment — the numbers ranged from 4 events in Cohort 5 (active) up to 28 events in Cohort 7 (active), with the placebo groups recording between 3 and 8 events. Regarding injection site reactions such as redness, swelling, pain, or itching, the reported data shows small numbers across some groups: zero reactions in several cohorts, and a high of 4 reactions in Cohort 4 (active). One participant in the placebo group for Cohort 6 did not complete the study; all other participants completed it. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04539964 · results posted 19 December 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT04539964) enrolled 242 people — 122 in the treatment group and 120 in the control group. The trial was looking at outcomes in people with rheumatoid arthritis, a condition that causes joint pain and swelling. The main thing being measured at 12 weeks was whether participants achieved at least a 20% improvement in joint tenderness, joint swelling, and several other measures of how the disease was affecting them (this is called an ACR20 response). A number of secondary measurements were also taken, including other joint-disease scoring systems and a questionnaire about how much difficulty people had with everyday tasks like dressing, walking, and eating. The reported data shows that for the primary outcome at 12 weeks, 43 out of 122 people in the treatment group and 29 out of 120 people in the control group met the ACR20 response criteria. For the secondary outcomes at 12 weeks: when using a different joint-disease scoring tool (DAS28-CRP), 74 people in the treatment group and 50 in the control group were recorded as having a "good or moderate" response; 55 in the treatment group and 39 in the control group showed a meaningful improvement on that same scoring tool using a specific threshold; and 56 in the treatment group compared with 44 in the control group showed a meaningful improvement on the everyday-tasks questionnaire. An additional measurement looked at bone damage progression on MRI scans — 18 people in the treatment group and 21 in the control group showed signs of worsening bone erosion over 12 weeks. The reported data also notes that the vast majority of participants completed the study — 120 out of 122 in the treatment group and 116 out of 120 in the control group finished. No other outcome figures beyond those described above were included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT05516758 · results posted 4 December 2025

    According to the results reported on ClinicalTrials.gov, this trial tested a drug called peresolimab in people with rheumatoid arthritis. A total of 491 participants were enrolled across several groups, each receiving different doses of peresolimab (1000 mg, 400 mg, or 100 mg) given by injection under the skin every four weeks, or a placebo (an inactive injection). Some participants later switched doses or frequency during the study. The trial's main goal was to measure how many people in each group showed at least a 20% improvement in a standard set of rheumatoid arthritis signs and symptoms (a scoring system called ACR20) by week 12 of the trial. The reported data shows that at week 12, 51.8% of participants in the 1000 mg group, 51.1% in the 400 mg group, and 44.1% in the 100 mg group met the ACR20 improvement threshold, compared with 39.3% in the placebo group. For the secondary measures — which looked at higher levels of improvement and other disease activity scores — the reported data shows that 22.7% (1000 mg), 19.1% (400 mg), and 11.8% (100 mg) of participants met the 50% improvement mark (ACR50), versus 10.7% on placebo. Fewer participants reached the 70% improvement mark (ACR70): 7.1%, 6.4%, and 7.4% across the three peresolimab doses respectively, compared with 2.9% on placebo. On other measures of disease activity — including scores assessing how active the arthritis was and whether it was in a low-activity or remission range — the reported percentages were generally higher in the peresolimab groups than in the placebo group, though the figures varied across doses and scoring methods. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04488497 · results posted 24 October 2025

    According to the results reported on ClinicalTrials.gov, this trial enrolled 101 people in total — 49 in a peer coach-guided online learning program and 52 in a self-administered online learning program (the control group). The trial was measuring whether people with a particular health condition would get their blood lipids (fats in the blood, such as cholesterol) checked, and also tracked several questionnaire-based measures including participants' confidence in managing their own health, how actively involved they felt in their own care, their symptom burden, mood, and social support. The reported data shows that for the main (primary) outcome — the number of people who had their lipid levels checked by the end of the study — 28 out of 38 participants in the peer coach group and 16 out of 40 participants in the control group did so. For the secondary outcomes, changes in scores were measured using the midpoint (median — the middle value when all results are lined up) of each person's change from the start to the end of the study. Both groups showed a median change of 1 point on the general self-confidence scale and a median change of 1 point on the health activation scale. On the symptom burden scale, the peer coach group showed no change (0.00) while the control group showed a very small decrease (−0.10). On the mood questionnaire, the peer coach group showed a median decrease of 1 point and the control group showed no change (0). For the social support survey, the peer coach group showed a median change of 1 point and the control group showed a median change of 2 points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT06418529 · results posted 31 July 2025

    According to the results reported on ClinicalTrials.gov, this study looked at records from 21,340 people in total — 3,681 taking tofacitinib, 11,667 taking a TNF inhibitor (a type of medicine that targets a protein involved in inflammation), 3,528 taking abatacept, and 2,464 taking an IL-6 inhibitor (another type of medicine targeting a different inflammation-related protein). All participants completed the study. The trial was comparing how often people on each of these rheumatoid arthritis medicines reached either "low disease activity" or "remission" — meaning their joint inflammation scores dropped to a low or very low level — over 6 and 12 months. Researchers used a scoring tool called the CDAI, which combines counts of swollen and tender joints with patients' and doctors' ratings of how active the disease felt. The reported data shows the results as "events per 1,000 person-years" — a way of counting how many times the low-disease-activity-or-remission milestone was reached across the group over time. At 6 months, the reported rates for tofacitinib versus TNF inhibitors were 426.8 and 471.9 respectively; versus abatacept, 421.1 and 486.6; and versus IL-6 inhibitors, 401.7 and 436.3. At 12 months, the reported rates were 185.5 (tofacitinib) versus 200.4 (TNF inhibitors); 185.2 versus 203.1 (abatacept); and 177.7 versus 181.7 (IL-6 inhibitors). In every comparison, the numbers reported for tofacitinib were somewhat lower than those for the medicines it was compared against, though what this difference means clinically was not described in the submitted data. It is worth noting that this was a real-world observational study — researchers analysed existing patient records rather than randomly assigning people to treatments — and a statistical adjustment method was used to try to account for differences between the groups at the start. No secondary outcome data beyond these primary measures was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT05198310 · results posted 22 July 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT05198310) tested a study drug called KPL-404 in people with rheumatoid arthritis — a condition that causes painful, swollen joints. The trial was divided into four groups (called cohorts) that tested different doses and dosing schedules of KPL-404 compared to a placebo (a dummy treatment with no active ingredient). In total, 145 people started the trial across all groups. The trial measured things like how the drug moved through the body (in the earlier cohorts), changes in joint disease activity over 12 weeks using a scoring tool called DAS28-CRP (a combined score based on tender and swollen joints, a patient-rated wellbeing scale, and a blood marker of inflammation — scored from 0 to 9.4, where lower is better), and how many participants experienced medical events during the study period. The reported data shows that in the earlier cohorts (1 and 2), which focused on how the body handled the drug, the peak blood concentration of KPL-404 was reported as 7.57 micrograms per millilitre for the lower dose and 28.0 micrograms per millilitre for the higher dose, with higher figures recorded at a later time point. For the disease activity score, the reported data shows that in cohorts 3 and 4 — the larger groups — the average change in DAS28-CRP score from the start of the trial to week 12 ranged from a decrease of 1.87 to 2.17 points across the KPL-404 groups, compared to a decrease of 1.30 to 1.61 points in the placebo groups. A negative number means the score went down (indicating less disease activity on average). In the smaller cohorts 1 and 2, the reported change in DAS28-CRP score was a decrease of 3.16 and 3.44 points respectively for the KPL-404 groups, compared to a decrease of 1.09 points for the placebo group. Regarding medical events that occurred during the study, the reported data shows that across cohorts 1 and 2, 2 out of 6 participants in each KPL-404 group and 3 out of 4 participants in the placebo group experienced a treatment-emergent medical event of any kind. In cohorts 3 and 4, 12 out of 27, 6 out of 25, 9 out of 31, and 8 out of 20 participants in the various KPL-404 groups experienced such events, compared to 8 out of 26 and 8 out of 20 in the respective placebo groups. The data does not provide a full breakdown of all event types reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04541589 · results posted 29 June 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT04541589) was an extension study of an earlier trial looking at a drug called iscalimab. A total of 206 participants took part — 152 people received the higher dose (600 mg) and 54 received the lower dose (300 mg). The trial's primary focus was on recording and counting any unwanted medical events (called adverse events) that occurred during or after treatment. It also measured how much of the drug was present in participants' blood over time, and whether participants' bodies produced antibodies against the drug. The reported data shows that, of the 152 participants in the 600 mg group, 127 experienced at least one adverse event of any kind during the study period; 57 of those were described as mild, 62 as moderate, and 8 as severe. Thirteen participants in that group experienced a serious adverse event — meaning one that required medical attention or hospitalisation. In the 300 mg group (54 participants), 43 experienced at least one adverse event; 24 mild, 17 moderate, and 2 severe. Two participants in the 300 mg group experienced a serious adverse event. Regarding the drug's levels in the blood, the reported data shows varying concentrations at different timepoints across both dose groups. As for antibodies against the drug, 1 participant in the 600 mg group and 2 participants in the 300 mg group were reported to have developed them at some point during the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03649061 · results posted 19 June 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT03649061) enrolled 110 people with rheumatoid arthritis — 55 in each group. One group received what the trial called "Standard COBRA-Slim Induction" (a combination of conventional medicines with a short course of steroid), and the other received "COBRA-Slim Bio-induction" (a similar approach but including a biologic medicine). Of the 110 who started, 92 completed the full two-year study (46 in each group). The trial was measuring disease activity over time, as well as a number of other disease-related outcomes at specific time points. The reported data shows that the main thing being measured was total disease activity accumulated over the full 104 weeks, scored on a scale where 0 is the lowest possible and 977.6 is the highest. A lower score means less disease activity over that period. The Standard COBRA-Slim group scored 297.4 and the COBRA-Slim Bio-induction group scored 300.7 — both of which fall in the "low disease activity" band as defined by the trial. For the secondary outcomes, the reported data shows that 28 weeks after starting, 24 participants in the standard group and 32 in the bio-induction group were recorded as being in remission among those who had not responded well enough initially. At the two-year mark, 38 participants in the standard group and 30 in the bio-induction group were reported to be in remission overall. Scores measuring patients' own rating of their physical ability (on a scale of 0–3, where higher means more difficulty) were reported as 0.7 for the standard group and 0.8 for the bio-induction group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02699190 · results posted 15 June 2025

    According to the results reported on ClinicalTrials.gov, this trial enrolled 236 participants in total. Of these, 80 were described as affected patients (people with the condition being investigated), and 156 were their biological parents. All 236 participants completed the study with none dropping out. The trial was looking at whether having a type of detailed genetic test called Whole Genome Sequencing (WGS) — which reads a person's full set of genetic instructions — changed anything for patients in terms of their diagnosis or their ongoing medical care. The reported data shows that for the primary outcome — tracking whether a participant's diagnosis changed as a result of WGS — 45 participants experienced a change in their diagnosis status, either at the time results were first shared with them or when those results were looked at again later. For the secondary outcome — whether WGS led to any changes in how patients were medically managed over the following year — the reported data shows three separate figures: 37 participants, 35 participants, and 8 participants. The trial record does not provide labels clearly explaining what each of these three numbers individually refers to, so it is not possible to describe exactly what each figure represents without risking misinterpretation. It is worth noting that this trial followed a single group of participants with no comparison group, meaning all figures simply describe what happened within that one cohort. No comparison or control data was reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT05572567 · results posted 8 June 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT05572567) followed 1,972 people with rheumatoid arthritis in Japan across four treatment groups: 298 taking methotrexate, 663 taking TNF inhibitors (a type of medicine that targets a protein involved in inflammation), 758 taking other non-TNF biologics, and 253 taking tofacitinib. All participants who started the study completed it. The trial was an observational registry — meaning researchers tracked participants in routine care rather than randomly assigning treatments — and it was measuring how often certain health events occurred, as well as changes in disease activity and daily functioning over time. The reported data shows event rates expressed as the number of people experiencing an event per 100 years of follow-up combined across the group. For cardiovascular events (such as heart attack or stroke), the reported rates were 0.51 for methotrexate, 0.76 for TNF inhibitors, 1.40 for other non-TNF biologics, and 1.54 for tofacitinib. For serious infections, the reported rates were 1.94, 2.61, 5.02, and 3.10 respectively. For herpes zoster (shingles), the rates were 0.90, 1.39, 2.18, and 8.07. For cancers (excluding a common, less serious type of skin cancer), the rates were 1.72, 1.71, 1.93, and 1.51. Regarding disease activity, all four groups showed a reduction in their disease activity score at six months, with changes ranging from −10.1 to −11.7 points on a 0–76 scale (where lower scores mean less disease activity). Daily functioning scores also showed small improvements across all groups at six months, with changes ranging from −0.2 to −0.3 on a 0–3 scale. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02783274 · results posted 22 May 2025

    According to the results reported on ClinicalTrials.gov, this trial looked at the Actis Total Hip System, a type of hip implant. A total of 266 people were enrolled, 255 received the implant, and 191 completed the study. Participants were split into two groups based on the type of procedure they had: 232 people had a total hip replacement (the entire hip joint replaced) and 23 had a partial hip replacement (only part of the joint replaced). The trial used a scoring tool called the Harris Hip Score to measure hip pain, movement, and everyday function at different points in time — at 3 months, 1 year, and 2 years after surgery. This score runs from 0 to 100, where higher numbers indicate better outcomes; scores of 90–100 are classed as "excellent," 80–90 as "good," 70–80 as "fair," and below 70 as "poor." The reported data shows the following Harris Hip Score results. For people who had a total hip replacement, the reported average score was 93.5 at 3 months, 95.7 at 1 year, and 95.7 at 2 years — all falling within the "excellent" range on the scale. For people who had a partial hip replacement, the reported average score was 85.3 at 3 months, 85.8 at 1 year, and 83.2 at 2 years — all falling within the "good" range on the scale. These were the scores recorded for participants who completed the study according to the trial's plan. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01820611 · results posted 20 January 2025

    According to the results reported on ClinicalTrials.gov, this trial enrolled 74 people who received a hip implant (the Arcos hip stem) coated with a substance called Bonemaster HA, which is designed to help bone attach to the implant. There was only one group in the study — everyone received the same implant. Of the 74 who started, 56 completed the study, and 18 did not complete it. The trial was measuring how many implants remained in place without needing to be replaced after five years, as well as tracking X-ray findings and patients' self-reported quality of life and hip function over time. The reported data shows that all 74 implants were recorded as unrevised (meaning none had been surgically replaced) at the five-year mark, which was the main thing the trial was set up to measure. For the X-ray assessments — which looked at signs of the implant shifting or gaps appearing between the implant and the bone — the reported data shows a range of participant counts across different measurement categories, but the detailed labels for each of those specific numbers were not included in the submitted data, so it is not possible to describe them individually. For the patient-reported scores, the reported data shows improvement over time across all three questionnaires: the EQ-5D quality-of-life score (which runs from below 0 to 1, where 1 is best) moved from 0.3 before surgery to 0.8 at the final follow-up; the Oxford Hip Score (out of 48, where higher is better) moved from 18.8 before surgery to 39.3; and the Harris Hip Score (out of 100, where higher is better) moved from 41.3 before surgery to 79.8. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04947137 · results posted 8 January 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT04947137) enrolled 134 people in total: 120 people who were free of inflammatory disease, and 14 people who were either healthy volunteers or had rheumatoid arthritis (RA) and were on stable treatment. All 134 participants who started the trial also completed it. The trial was looking at a substance called tilmanocept, used in a type of body scan, to understand how it shows up in the joints of the hands and wrists — specifically to establish what "normal" levels look like in healthy people and to compare those with readings in people who have RA. The reported data shows that the two main (primary) outcome measures — establishing normal reference ranges for joint uptake of tilmanocept, and assessing whether the substance could be visually identified in hand and wrist joints — did not have any numerical results submitted to ClinicalTrials.gov. The same applies to the secondary outcome measures, which looked at the distribution of uptake values, detailed scan measurements from a specific imaging technique (SPECT/CT), and a comparison between two different types of scans. No figures were reported for any of these outcomes, so it is not possible to describe what those measurements showed. The reported data does include some figures related to a safety-monitoring objective. Among the group free of inflammatory disease, numbers such as 2, 1, 2, and 13 participants were recorded across different safety-related categories (for example, those experiencing adverse events — that is, unwanted health changes noted during the trial). In the healthy controls/RA group, the corresponding figures were 0, 0, 0, and 8 participants respectively. No further detail about what each specific category represented was provided in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04909801 · results posted 15 October 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT04909801) enrolled 169 participants in each of two groups — one group received a medicine called abatacept, and the other initially received a different medicine called adalimumab before switching to abatacept in an open-label extension period. The trial was primarily measuring how many participants, specifically those with a particular genetic marker (referred to as "SE+"), showed at least a 50% improvement in rheumatoid arthritis symptoms by week 24, using a standard set of measures known as the ACR50 criteria. Several secondary measures were also tracked, including disease activity scores, remission rates, and self-reported pain levels. The reported data shows that at week 24, approximately 59.0% of participants in the abatacept group and 60.3% in the adalimumab-then-abatacept group met the ACR50 response threshold in the SE+ population. For the secondary outcomes, the reported data shows that around 44.4% and 46.6% of participants (abatacept and adalimumab-then-abatacept groups respectively) reached a disease activity score low enough to be classed as remission on the DAS28-CRP scale (a score below 2.6). A separate remission measure called CDAI showed remission rates of 33.3% and 35.3% respectively. On a self-reported pain scale of 0–100 (where higher means more pain), average scores decreased by about 40.9 points in the abatacept group and 37.7 points in the adalimumab-then-abatacept group from the start of the trial to week 24. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT05487703 · results posted 8 October 2024

    According to the results reported on ClinicalTrials.gov, this trial enrolled 318 participants who were all taking a medicine called tofacitinib. There was only one group in the study — no comparison group. Of the 318 who started, 232 reached the six-month visit point and 209 completed the study, while 109 did not finish. The trial was an observational registry study, meaning it was designed to collect detailed background information about the people taking this medicine rather than to test whether the medicine works. The measurements focused on participants' personal and health characteristics at the time they started tofacitinib. The reported data shows a range of background details about participants. In terms of health insurance, 210 out of 318 participants had private insurance, 147 had Medicare, 20 had Medicaid, and 4 had no insurance. Regarding education, 206 out of 318 had completed college or higher. For smoking, 149 had never smoked, 110 were former smokers, and 55 were current smokers. When it came to alcohol use, 224 reported drinking alcohol, 52 did not drink, 24 were former drinkers, and 1 result was recorded separately. On work status, the reported data shows participants spread across categories including full-time work, part-time, and not working, though the exact labels for each number were not detailed in the submitted data. Regarding existing health conditions (comorbidities), various counts were recorded across six categories, ranging from 2 to 136 participants per category. It is important to note that this study was purely descriptive — it recorded who the participants were, not whether the medicine produced any particular health outcome. No efficacy or safety findings were included in the results submitted to ClinicalTrials.gov for this trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04888585 · results posted 8 October 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT04888585) enrolled 473 adults with rheumatoid arthritis across four treatment groups and a placebo group. In the first 12-week phase, participants received either a placebo (an inactive injection) or one of four different doses of an investigational drug called ABBV-154, given either every two weeks or every four weeks. The trial was primarily measuring how many people achieved at least a 50% reduction in joint tenderness, joint swelling, and several other disease markers — a standard benchmark in rheumatoid arthritis research known as an "ACR50 response." After week 12, most participants moved into an extension phase where they continued or switched to active treatment; however, the reported data shows that no participants had completed that longer phase at the time of the data cut. The reported data shows that in the main 12-week comparison, 6.3% of participants in the placebo group met the ACR50 benchmark, compared with 25.5% in the lowest ABBV-154 dose group (40 mg every two weeks), 33.3% in the 150 mg every-two-weeks group, 44.4% in the highest dose group (340 mg every two weeks), and 30.9% in the 340 mg every-four-weeks group. For a less strict measure — at least a 20% improvement across the same criteria (ACR20) — the figures were 28.1% for placebo, and ranged from 52.7% to 74.4% across the ABBV-154 groups. For the strictest measure (70% improvement, ACR70), the reported figures were 3.1% for placebo and between 4.3% and 13.3% across the ABBV-154 groups. The reported data also shows results for several secondary measures. On a disease activity scoring tool called DAS28 (which runs from 0 to about 10, with higher scores meaning more active disease), the average score fell by 1.08 points in the placebo group, and by between 1.59 and 2.51 points across the ABBV-154 groups. On a similar tool called CDAI (scored 0–76, higher meaning more active disease), the placebo group's average score dropped by 14.21 points, while the ABBV-154 groups showed drops ranging from 18.77 to 25.62 points. The proportion of participants reaching a "low disease activity" level on the DAS28 scale was 20.8% for placebo, compared with 38.9% to 53.3% across the ABBV-154 groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04057118 · results posted 31 July 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT04057118) enrolled 163 adults across four groups to test three different daily doses of an investigational medicine called SKI-O-703 (100 mg, 200 mg, and 400 mg) compared with a placebo (an inactive pill) in people with rheumatoid arthritis. The main thing being measured was a standard scoring system called DAS28, which combines information about tender and swollen joints and a blood marker of inflammation to give a picture of how active a person's arthritis is — a higher score means more active disease. Between 36 and 39 participants in each group completed the study. The reported data shows that, on average, all four groups saw a reduction in their DAS28 score from the start of the study to the end. The placebo group's average score dropped by 0.95 points, the 100 mg group by 0.91 points, the 200 mg group by 1.06 points, and the 400 mg group by 1.15 points. For the secondary measures — which looked at how many participants showed meaningful improvements across a broader set of joint and function assessments (called ACR20, ACR50, and ACR70, where higher numbers mean more improvement) — the reported data shows that relatively small numbers of participants in each group met those thresholds across the different time points measured. A self-reported disability questionnaire (scored 0–3, where lower is less disability) also showed small reductions from baseline across all groups. The reported data also notes the number of participants who experienced adverse events (unexpected health issues during the trial): 19 in the placebo group, 16 in the 100 mg group, 23 in the 200 mg group, and 25 in the 400 mg group, though further detail on the nature of those events was not included in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02065700 · results posted 4 June 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT02065700) enrolled a total of 739 participants across two groups — 497 in the "Darwin 1" group and 242 in the "Darwin 2" group — all receiving the study drug filgotinib. The trial was a long-term follow-on study measuring undesirable medical events that occurred during treatment, as well as tracking how participants' rheumatoid arthritis symptoms responded over time using standard scoring tools used in arthritis research. The reported data shows that the primary thing being counted was the number of participants who experienced any undesirable medical event (called a "treatment-emergent adverse event") while on the drug — this includes anything that happened medically during the study period, whether or not it was thought to be related to the treatment. Of the 497 participants in the Darwin 1 group, 453 had at least one such event reported; in the Darwin 2 group, 223 out of 242 participants had at least one such event reported. For the secondary measures, the trial tracked what percentage of participants showed meaningful reductions in joint swelling, joint tenderness, pain, and other disease markers at various points in time. The reported data shows that, depending on the time point and the scoring threshold used, roughly 67–84% of participants in both groups met the criteria for a 20% improvement in symptoms, roughly 45–68% met the criteria for a 50% improvement, and roughly 23–41% met the criteria for a 70% improvement. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04605978 · results posted 23 April 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT04605978) enrolled 48 people with primary Sjögren's syndrome — a condition that affects the immune system and can cause dryness, fatigue, and joint problems. Thirty-one participants received the active treatment (S95011, given as an infusion into a vein), and 17 received a placebo (an inactive infusion used for comparison). The trial was measuring changes in disease activity and symptoms using several standardised questionnaires and doctor assessments. The primary thing being measured was a doctor-assessed disease activity score called the ESSDAI (which runs from 0 to 123, where lower numbers mean less disease activity). The reported data shows that, at the start of the trial, the active treatment group had an average ESSDAI score of around 11.5 and the placebo group around 13.1. By the end, both groups showed lower scores — the active treatment group's score changed by an average of −3.77 points, while the placebo group's score changed by −5.54 points. For the secondary measures — including patient-reported symptoms (dryness, fatigue, pain), quality of life, fatigue scales, and the doctor's overall rating of disease activity — the reported data shows scores in both groups that were broadly similar at the start and at the end of the study, with both groups showing some reductions across most measures over time. It is worth noting that the data as submitted does not include statistical comparisons between the two groups, so no conclusions about whether the differences between the active treatment and placebo were meaningful can be drawn from the figures alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04662359 · results posted 16 April 2024

    According to the results reported on ClinicalTrials.gov, this trial enrolled 18 adults with rheumatoid arthritis (a condition where the immune system attacks the joints, causing inflammation). All 18 participants completed the study — none dropped out. The trial was looking at whether ultrasound scans could be used to measure the level of joint inflammation (called synovitis) in these patients, and whether that ultrasound information had any bearing on the treatment decisions made by their doctors. The reported data shows that the trial used a recognised scoring system where each joint is given a score from 0 to 3, with higher numbers meaning more inflammation. Patients who scored 1 or lower in all of their measured joints were considered to have "low synovitis scores." Out of the 18 participants, the reported data shows that only 1 person had low synovitis scores by this measure. For the second outcome being tracked, the reported data shows that for 6 out of the 18 participants, the information from the ultrasound scan was associated with a change in the treatment recommendation made by their clinical provider. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04333147 · results posted 7 February 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT04333147) enrolled 2,915 people in total — 1,456 in the Otilimab 90 mg group and 1,459 in the Otilimab 150 mg group. The trial was measuring the safety profile of two different doses of a medicine called otilimab, tracking things like unwanted medical events (called adverse events), serious adverse events, and certain events flagged as being of special interest. It also measured changes in two blood test results — platelet count (tiny blood cells involved in clotting) and haemoglobin (a protein in red blood cells that carries oxygen) — at several points over the study period. It is worth noting that the data shows zero participants were recorded as having "completed" the study, meaning all participants were listed under "not completed," though the reasons for this were not explained in the submitted data. The reported data shows that, when it came to unwanted medical events, 902 people in the 90 mg group and 931 people in the 150 mg group experienced at least one adverse event. Serious adverse events were recorded in 123 people (90 mg group) and 114 people (150 mg group), and adverse events of special interest occurred in 120 and 95 people respectively. For platelet count, the reported data shows small reductions from baseline in both groups at weeks 24, 48, and 96. At week 144, the 90 mg group showed an average increase of 17.0 units, while the 150 mg group showed a larger average decrease of 37.5 units — though the data does not explain this difference. For haemoglobin at week 24, the reported change from baseline was very small: +0.4 g/L in the 90 mg group and +0.3 g/L in the 150 mg group. Haemoglobin results beyond week 24 were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01664598 · results posted 11 December 2023

    According to the results reported on ClinicalTrials.gov, this trial enrolled 49 participants, all of whom received the medicine tocilizumab. By the end of the study, 43 participants had completed it, while 6 did not finish. The trial was primarily measuring how often participants experienced unwanted medical events (called adverse events), including serious ones and those of special interest such as serious infections or abnormal liver test results. It also tracked changes in disease activity scores over time using several different measurement tools. The reported data shows that 69.4% of participants experienced at least one adverse event of any kind, 10.2% experienced a serious adverse event, and 17.2% experienced an adverse event of special interest. Looking at the severity of those adverse events, 62.1% were rated as mild, 36.8% as moderate, and 1.1% as severe. Around 34.5% of all adverse events led to a change in the dose of the medicine, while 1.1% led to a participant leaving the study. Regarding disease activity, the reported data shows that scores on the DAS28-ESR scale (a tool that measures joint tenderness, swelling, and inflammation markers on a scale of 0–10) fell by between roughly 25% and 38% from the starting point at various time points across the study. Similarly, scores on the SDAI (another disease activity tool based on joint counts and other assessments) fell by between roughly 6% and 47% at different time points. The number of tender joints out of 66 also decreased from the starting point, with reductions of between approximately 5 and 7 joints reported at different times during the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04268771 · results posted 18 November 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT04268771) enrolled 140 people in total — 70 in each group. One group received DRL\_RI (a rituximab product being studied as a potential biosimilar, meaning a medicine intended to be very similar to an already-approved one), and the other group received either the US or EU version of the reference rituximab medicine. The trial was primarily measuring whether participants' immune systems produced antibodies against the study medicine — known as "anti-drug antibodies" (ADA) — at several points in time. An anti-drug antibody is simply a protein the body can make in response to a medicine it recognises as foreign. Overall, 66 people in the DRL\_RI group and 68 in the reference group completed the study. The reported data shows that the number of participants whose blood tests came back positive for anti-drug antibodies was low in both groups across all time points measured. On Day 1, 3 participants in the DRL\_RI group and 1 in the reference group tested positive. On Day 15, 1 participant in the DRL\_RI group and 0 in the reference group tested positive. At Week 4, no participants in either group tested positive. At Week 8, 1 participant in the DRL\_RI group and 0 in the reference group tested positive. At Week 12, 1 participant in the DRL\_RI group and 2 in the reference group tested positive. The reported data also shows one secondary (additional) outcome was measured: the number of participants who experienced a severe allergic reaction called an anaphylactic reaction at the time of receiving the study medicine (either at Week 1 or Week 3). According to the results reported on ClinicalTrials.gov, zero participants in either group reported such a reaction at those dosing time points. No other secondary outcome data appears to have been reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03938636 · results posted 24 August 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT03938636) enrolled 116 people across three groups: 44 people who did not have any inflammatory disease (healthy volunteers), 41 people with rheumatoid arthritis (RA) who were already on a stable treatment, and 31 people with RA who were about to start a new type of medication called an anti-TNFα therapy. The trial was studying a scanning technique that uses a substance called tilmanocept — which is taken up by certain cells in the body — to measure activity in hand and wrist joints. The main goals were to check how consistent and reliable the scans were, and to see whether early changes in scan readings could be related to how patients responded to their new medication over time. The reported data shows that for the consistency checks, the scans produced very small variation numbers (measured in units called "pixel intensity") across different cameras and time points, with figures generally ranging from around 0.067 to 0.263 for both the healthy volunteers and the stable-therapy RA group. A separate measure of variability called the "coefficient of variation" (a way of expressing how spread out results are) was also reported across both groups at different time points, with values ranging roughly from 12 to 263 — the very high figure of 263 came from one specific measurement in the healthy volunteer group. For the third group — those starting a new medication — the trial measured whether early changes in scan readings after five weeks were linked to changes in disease scores at 12 and 24 weeks. The reported correlation figures (a number between −1 and +1 showing how closely two things move together) ranged from about 0.115 to 0.248, indicating a modest relationship at most. A secondary measure found that none (0%) of the stable-therapy RA participants who had a special type of detailed scan (SPECT/CT) showed signs that the tracer had gone into bone tissue rather than the joint lining space. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02833311 · results posted 12 May 2023

    According to the results reported on ClinicalTrials.gov, this trial involved 46 people in total, split across three groups: a Computer Tablet Group (15 people), a Paper and Pencil Group (16 people), and a Standard Treatment Control Group (15 people). The trial was measuring whether different ways of delivering a physical activity program — using a computer tablet, pen and paper, or standard care — were associated with changes in physical activity levels, walking ability, self-reported physical function, confidence in exercising, and body weight. By the end of the study, 43 of the 46 participants had completed the trial (13, 15, and 15 in each group respectively). The reported data shows the following across the three groups. For the main (primary) outcome — physical activity levels measured using a questionnaire with scores ranging from roughly -2.75 to 3.37 (where a higher number means more activity) — all three groups showed slightly higher scores at follow-up compared to baseline. The Computer Tablet Group moved from 0.36 to 0.76, the Paper and Pencil Group from 0.31 to 0.55, and the Control Group from 0.43 to 0.36. For the secondary outcomes, the reported data shows: self-reported physical function scores (where 50 represents an average reference population) were in the high-30s to low-40s across all groups at both time points, with modest changes; distance walked in six minutes ranged from around 304–362 metres at baseline and 320–385 metres at follow-up across the three groups; confidence in exercising (scored 1–60) sat between approximately 2.97 and 3.42 across all groups and time points; and average body weight ranged from roughly 82–92 kg across groups, with very small differences between baseline and follow-up measurements. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04163991 · results posted 14 February 2023

    According to the results reported on ClinicalTrials.gov, this trial looked at a drug called VIB4920 in people with rheumatoid arthritis (a condition where the immune system attacks the joints). A total of 78 people took part, split across five groups: one group received a placebo (a dummy treatment with no active ingredient), while the other four groups received different doses and dosing schedules of VIB4920. The trial mainly measured changes in joint disease activity using a standard scoring tool called the DAS28-CRP — a scale from 0 to about 10, where higher numbers mean more active disease — as well as tracking any unwanted medical events (called adverse events) that occurred during the study. The reported data shows that, on average, all groups had lower disease activity scores by Day 113 compared to where they started — meaning scores went down across the board. The placebo group's score dropped by 1.06 points on average, while the four VIB4920 groups each dropped by between 1.83 and 1.90 points on average. Regarding unwanted medical events, the reported data shows that 10 people in the placebo group and between 10 and 14 people across the VIB4920 groups experienced at least one adverse event during the study. Serious adverse events were reported in 4 people in the placebo group and in 2 to 4 people across the VIB4920 groups. The trial also measured how the drug moved through the body (pharmacokinetics), though the reported data for those measures is complex and was not fully reported for all groups and timepoints. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02808871 · results posted 16 August 2022

    According to the results reported on ClinicalTrials.gov, this trial (NCT02808871) enrolled 123 participants in total — 63 received pirfenidone (the medicine being studied) and 60 received a placebo (a dummy treatment with no active ingredient). The trial ran for 52 weeks and was measuring things related to lung function, specifically a breathing test called FVC (forced vital capacity, which measures how much air a person can breathe out). The main thing the trial was tracking was how many participants either experienced a significant drop in their lung function (a fall of 10% or more in their FVC score) or died during the study period. The reported data shows that, for the primary (main) outcome, 7 out of 63 participants in the pirfenidone group and 9 out of 60 in the placebo group reached that combined milestone of significant lung function decline or death. For the secondary (additional) outcomes, the reported data shows: 5 pirfenidone participants versus 7 placebo participants had a lung function drop of 10% or more on its own; 16 pirfenidone participants versus 19 placebo participants were classified as having progressive (worsening) disease using a broader definition. In terms of average changes in lung function over the 52 weeks, the pirfenidone group showed an average decline of 66 ml in the actual volume of air breathed out, compared with an average decline of 146 ml in the placebo group. Expressed as a percentage of the predicted normal value, the pirfenidone group declined by an average of 1.02% and the placebo group by 3.21%. The reported average time to reaching the combined milestone of lung function decline or death was 349.5 days in the pirfenidone group and 339.9 days in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04577781 · results posted 18 July 2022

    According to the results reported on ClinicalTrials.gov, this trial (NCT04577781) enrolled 28 people in total — 16 received a drug called GLPG3970 and 12 received a placebo (a dummy treatment with no active ingredient). The trial was looking at rheumatoid arthritis and ran for 6 weeks. Its main goal was to measure changes in something called the DAS28-CRP score, which is a combined score that takes into account tender and swollen joint counts, a blood marker of inflammation (CRP), and how the patient rated their own disease activity. A lower score on this scale indicates less disease activity. The reported data shows that, on average, participants in the GLPG3970 group had a change of −1.29 points in their DAS28-CRP score from the start of the trial to week 6, while those in the placebo group had a change of −1.24 points. Regarding side effects (called adverse events in clinical research), the reported data shows that 6 out of 16 participants in the GLPG3970 group and 2 out of 12 in the placebo group experienced a treatment-emergent adverse event (meaning an unwanted health event that occurred during or shortly after taking the treatment). No serious adverse events — defined as those involving hospitalisation, life-threatening situations, or significant disability — were reported in either group. The trial also measured the level of GLPG3970 in participants' blood at various points; reported levels ranged from approximately 49.8 to 103 nanograms per millilitre, though the exact timepoints for these measurements were not described in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01296711 · results posted 14 April 2022

    According to the results reported on ClinicalTrials.gov, this trial (NCT01296711) enrolled 190 people in total across eight groups. Participants received one of several doses of olokizumab (also called CDP6038) given either every two weeks or every four weeks, a placebo (an inactive treatment), or another medicine called tocilizumab. The trial was measuring how many people experienced unexpected health events (called adverse events) after starting treatment, and also tracking changes in a standard rheumatoid arthritis disease activity score known as DAS28(CRP) — a number from 0 to 10 where a higher score means more active disease. A fall in this score over time indicates lower disease activity, though it does not on its own confirm a treatment is working. Completion numbers were relatively low across all groups, ranging from 4 to 15 people per group finishing the study. The reported data shows that for the primary measure — the number of participants who experienced a treatment-related adverse event — nearly all participants across every group recorded at least one such event. Specifically, the numbers ranged from 15 out of 16–17 participants in the 60 mg groups, up to 39 out of 40 in the placebo group and 35 out of 36 in the tocilizumab group. For the secondary disease activity score measure, the reported data shows that across all groups and all time points measured (weeks 12, 24, 48, and 96), the average DAS28(CRP) scores were lower than they were at the start of the study — meaning the scores moved in a downward direction in all groups including placebo. The size of these reported score changes ranged roughly from about −1.7 to −3.8 across the different groups and time points. One result, the 120 mg every-four-weeks group at week 24, showed a reported value of +1.47, meaning an average increase in score at that time point, though it is not possible from this data alone to explain why. For the ACR20 measure (the percentage of people who showed at least a 20% improvement across several arthritis markers at week 12), the reported figures ranged from 35.0% in one olokizumab group to 76.2% in another, with 47.5% reported for the placebo group and 52.8% for the tocilizumab group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03691909 · results posted 22 March 2022

    According to the results reported on ClinicalTrials.gov, this trial (NCT03691909) enrolled 15 people with acute rheumatoid arthritis (a condition causing painful, swollen joints). All 15 participants were in a single treatment group and received one injection of a cell-based treatment called HB-adMSCs (cells derived from fat tissue). The trial ran for 12 months and was primarily designed to track the number of unwanted health events (called adverse events) that occurred, with blood markers and joint counts recorded as secondary measurements. The reported data shows that across the full 12 months, a total of 27 adverse events (unwanted health events of any kind) were recorded across all participants. The reported data also shows these events broken down over time, with 15 events recorded at one time point, then 8, 4, 4, 0, and 0 at subsequent time points — though the specific time points for each of these numbers were not clearly labelled in the submitted data. For the secondary measurements, single figures were reported for each blood marker at an unspecified time point: TNF-alpha (a protein linked to inflammation) was recorded at 1.15 pg/mL, IL-6 (another inflammation-related protein) at 4.60 pg/mL, CRP (a general inflammation marker in the blood) at 6.00 mg/L, and ESR (a measure of how quickly red blood cells settle, also linked to inflammation) at 34.5 mm/hr. The reported data shows that the number of tender and swollen joints counted was 1.00 for both the tender and swollen joint measures. It is important to note that the data as submitted does not include before-and-after comparisons for these secondary measurements, so no change over time can be calculated from the figures provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01885078 · results posted 1 February 2022

    According to the results reported on ClinicalTrials.gov, this trial (NCT01885078) involved people with rheumatoid arthritis — a condition where the immune system attacks the joints — and tested a medicine called baricitinib at two doses (2 mg and 4 mg). The trial was run across several sub-studies (given internal code names such as JADZ, JADV, JADX, JADW, JAGS, and JADA), with participants either staying on their assigned dose throughout or moving into a "step-down" phase where doses could be reduced. In total, across all groups, more than 2,800 people started the treatment period, and a further 1,186 entered the step-down period. The primary outcome — what the trial was mainly set up to count — was the number of participants who experienced any unwanted medical event (called an adverse event, or AE) or a serious adverse event (SAE, meaning something more severe such as hospitalisation or a life-threatening event). The reported data shows that, across the combined 2 mg groups, 234 participants experienced AEs and 112 experienced SAEs. Across the combined 4 mg groups, 1,532 participants experienced AEs and 517 experienced SAEs. In the step-down groups, the reported figures were 270 AEs and 164 SAEs for the 2 mg step-down group, and 315 AEs and 178 SAEs for the 4 mg step-down group. The trial also tracked a standard rheumatoid arthritis score called ACR20 (meaning at least a 20% improvement in joint tenderness, swelling, and related measures) and ACR50 (at least 50% improvement). The reported data shows ACR20 rates across the different sub-study groups ranging from approximately 43% to 93% depending on the group and the time point measured, while ACR50 rates ranged from approximately 37% to 80% across groups and time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01146652 · results posted 24 January 2022

    According to the results reported on ClinicalTrials.gov, this long-term follow-up trial (NCT01146652) involved two groups of participants with rheumatoid arthritis who were already taking sarilumab: one group took sarilumab together with other arthritis medicines called DMARDs (1,912 people started), and a smaller group took sarilumab on its own (111 people started). A smaller sub-group of 124 participants also took part in a separate sub-study that looked at how well a new type of pre-filled safety syringe worked in practice. The trial was primarily measuring how often participants experienced unwanted medical events (called adverse events) and serious adverse events, as well as how the syringe device performed. The reported data shows that, in the main study, 1,760 out of 1,910 treated participants in the combination group, and 98 out of 111 in the monotherapy group, experienced at least one treatment-emergent adverse event (that is, any unwanted medical occurrence during the treatment period). Serious adverse events — those involving hospitalisation, life-threatening situations, or other significant medical concerns — were reported in 617 participants in the combination group and 27 in the monotherapy group. For the syringe sub-study, the reported data shows zero confirmed technical failures across all three dosing sub-groups, though 5 participants in the 200 mg dose sub-group reported complaints about the syringe and were recorded as having a failed drug delivery (meaning they could not deliver the full dose in a given attempt). As a secondary measure, the trial also tracked the proportion of participants who showed meaningful improvement in joint and symptom scores (known as an ACR20 response — at least a 20% improvement across several arthritis measures). The reported data shows these figures ranged from approximately 69% to 83% across different time points in the combination group, and from approximately 82% to 93% across time points in the monotherapy group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04608344 · results posted 19 January 2022

    According to the results reported on ClinicalTrials.gov, this trial (NCT04608344) enrolled 27 participants across two groups. The trial was looking at how the body absorbs and processes a drug called filgotinib when taken alongside two types of cholesterol-lowering medicines — atorvastatin and a combination of pravastatin and rosuvastatin. To do this, the researchers measured drug levels in the blood at different points in time. Each group took the medicines in a different order across two periods, and most participants completed the trial (25 out of 27 finished both periods). The reported data shows the main measurements were about how much of each drug reached the bloodstream and what the peak blood levels were. For atorvastatin alone, the total drug exposure over time (a measure called AUC, meaning the overall amount of drug in the blood) was reported at 78.8 to 80.8 units, compared to 70.2 to 71.8 units for the pravastatin/rosuvastatin combination. When filgotinib was taken at the same time, the reported AUC figures were higher — 201.3 to 234.8 units for atorvastatin with filgotinib, and 62.6 to 92.3 units for pravastatin/rosuvastatin with filgotinib. Peak blood concentration figures followed a similar pattern. For the secondary outcomes, the reported data shows that 19.2% of participants taking atorvastatin alone, and 24.0% taking pravastatin/rosuvastatin alone, experienced treatment-emergent adverse events (unexpected medical occurrences during the study period), compared with 65.4% taking filgotinib alone, 7.7% taking filgotinib with atorvastatin, and 11.5% taking filgotinib with the pravastatin/rosuvastatin combination. Severe laboratory abnormalities (Grade 3 or higher) were reported in 3.8% of participants in the filgotinib-alone period, and 0% across all other groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01123070 · results posted 4 October 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT01123070) involved two parts. In the first part (Part A), six people took part in an open-label phase — three receiving a 500 mg dose of TL011 and three receiving a 1,000 mg dose of TL011. In the second part (Part B), 48 people took part in a double-blind phase (meaning neither the participants nor the researchers knew who was receiving which treatment) — 25 received TL011 at 1,000 mg and 23 received MabThera (also known as rituximab) at 1,000 mg. The trial was primarily measuring how the drug moved through the body over time — specifically tracking drug levels in the blood — to compare TL011 against MabThera. The reported data shows that for the main measurement (the total amount of drug in the blood over time, called "AUC"), the TL011 group had a value of 7,571 and the MabThera group had a value of 8,377 (both measured in day-micrograms per millilitre). For the peak drug level reached in the blood, the TL011 group recorded 396 micrograms per millilitre compared to 450 for MabThera. When looking at each dose separately, the reported peak levels and overall drug exposure figures were broadly in a similar range between the two groups across both the first and second doses. Regarding a type of immune cell called CD19+ B-cells, the reported data shows a change from the starting level of −88.9% in the TL011 group and −90.6% in the MabThera group — meaning both groups showed a large reduction in these cells, as measured during the trial. The reported data also shows that in Part B, 14 out of 25 participants in the TL011 group and 16 out of 23 participants in the MabThera group experienced at least one adverse event (an unexpected medical occurrence during the study period). The trial did not provide further breakdown of these events in the structured results submitted to ClinicalTrials.gov, so no additional detail on the nature of those events can be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00383188 · results posted 20 August 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 302 people with rheumatoid arthritis across five groups. Participants were assigned to receive one of four different daily doses of an investigational drug called PH-797804 (0.5 mg, 3 mg, 6 mg, or 10 mg) or a placebo (a dummy treatment with no active ingredient). The trial's main question was whether, after 12 weeks, participants met a standard rheumatology benchmark called "ACR20" — meaning their tender and swollen joint counts, plus several other measures of pain and disability, had each improved by at least 20% compared to when they started. The reported data shows that at the 12-week mark, the percentage of participants who met the ACR20 benchmark was: 39.1% in the 0.5 mg group, 41.9% in the 3 mg group, 40.9% in the 6 mg group, 40.0% in the 10 mg group, and 31.1% in the placebo group. For the secondary measures, the reported data shows that at various earlier time points, smaller proportions met a stricter 50% improvement benchmark (ACR50), and very few met the even stricter 70% improvement benchmark (ACR70). The reported data also shows that all groups, including the placebo group, recorded reductions in the average number of tender and swollen joints over the course of the trial. Not all time-point data for the secondary outcomes was fully reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02092467 · results posted 17 August 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT02092467) enrolled around 4,370 participants in total, split across three groups: those taking tofacitinib at a lower dose (5 mg twice daily), those taking tofacitinib at a higher dose (10 mg twice daily), and those taking a different type of medication called a TNF inhibitor (TNFi), which was used as a comparison group. The trial was measuring how often certain serious health events — specifically cancers (excluding a common skin cancer type), major heart and stroke events, serious infections, liver events, heart attacks, and strokes — occurred across these groups over the course of the study. The reported data shows the results as rates — roughly, how many events occurred per 100 people per year of follow-up. For cancers (excluding non-melanoma skin cancer), both tofacitinib groups combined reported a rate of 1.13, compared to 0.77 in the TNFi group. For major heart and stroke events combined, the reported rates were 0.91 (lower tofacitinib dose), 1.05 (higher dose), and 0.73 (TNFi). For non-fatal stroke specifically, the reported rates were 0.27, 0.33, and 0.34 respectively. For non-fatal heart attacks, the rates were 0.37, 0.33, and 0.16. For serious infections (including tuberculosis), the reported rates were 0.76, 0.91, and 0.42. For liver-related events, the reported rates were 0.90, 1.51, and 0.70 for the lower tofacitinib dose, higher tofacitinib dose, and TNFi groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02919475 · results posted 14 June 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT02919475) enrolled 259 people with rheumatoid arthritis across five groups. Participants were randomly assigned to receive one of four daily doses of an investigational medicine called JTE-051 (50 mg, 100 mg, 150 mg, or 200 mg) or a placebo (a dummy treatment with no active ingredient), and were followed for up to 12 weeks. The trial was primarily measuring how many people in each group achieved at least a 20% improvement across a standard set of rheumatoid arthritis measures — a benchmark known as an "ACR20 response." Between 38 and 48 people in each group completed the full study period. The reported data shows that, for the primary goal at the end of treatment, the number of participants reaching the ACR20 threshold was 27 in the 50 mg group, 31 in the 100 mg group, 27 in the 150 mg group, and 30 in the 200 mg group, compared with 29 in the placebo group. For the secondary measures at Week 12, the reported data shows similar ACR20 numbers (26, 28, 25, and 24 across the four dose groups versus 28 for placebo). When a stricter improvement threshold of 50% (ACR50) was applied at Week 12, the numbers were 10, 12, 8, and 11 across the dose groups versus 10 for placebo. At the most stringent threshold of 70% improvement (ACR70), the numbers were 3, 5, 4, and 4 across the dose groups versus 0 for placebo. For the two composite disease-activity score measures (SDAI and CDAI), all groups — including placebo — showed reductions from their starting scores at Week 12, with changes ranging from approximately −18 to −22 points across the JTE-051 groups and approximately −18 and −17 points respectively in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03247686 · results posted 2 April 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT03247686) looked at a treatment called RSLV-132 in people with Sjögren's syndrome, an autoimmune condition. A total of 28 people took part — 8 received a placebo (a dummy treatment with no active ingredient) and 20 received RSLV-132. Most participants finished the study: 7 out of 8 in the placebo group and 18 out of 20 in the RSLV-132 group. The trial was primarily measuring changes in the activity of three specific genes in blood cells that are linked to a part of the immune system called the interferon pathway, which is known to be altered in Sjögren's syndrome. A secondary measurement looked at overall disease activity using a standardised scoring tool called the ESSDAI, which runs from 0 to 123, where higher numbers mean more disease activity. The reported data shows that for the main measurement — gene activity expressed as a "log2 fold change" (a way of describing how much the gene activity shifted from the starting point) — the placebo group showed very small negative changes across the three genes (around −0.03 to −0.06), while the RSLV-132 group as a whole showed small positive changes (around +0.03 to +0.13). Within the RSLV-132 group, participants labelled "responders" showed slightly larger positive changes than those labelled "non-responders." For the secondary disease activity score, the reported data shows the placebo group had an average decrease of 2.5 points from their starting score, while the RSLV-132 group had an average change of 0.0 points — meaning no change on average — by day 99. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02889796 · results posted 19 January 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT02889796) enrolled a total of 1,759 people across several groups: 477 received filgotinib 200 mg, 480 received filgotinib 100 mg, 325 received adalimumab (an existing treatment used for comparison), and the remaining participants received a placebo (an inactive dummy treatment). The trial was primarily measuring how many people with rheumatoid arthritis showed at least a 20% improvement in joint tenderness, joint swelling, and several other disease markers after 12 weeks — a standard benchmark known as an "ACR20 response." It also tracked a range of other measurements, including physical function, quality of life, and changes visible on joint X-rays. The reported data shows that at the 12-week mark, 76.6% of participants in the filgotinib 200 mg group, 69.8% in the filgotinib 100 mg group, and 70.5% in the adalimumab group met the ACR20 response threshold, compared with 49.9% in the placebo group. For the secondary outcomes, the reported data shows changes in a physical disability score (HAQ-DI, where a lower number means less difficulty) — participants in the filgotinib 200 mg group had an average change of −0.69 points from their starting score, the 100 mg group −0.56, the adalimumab group −0.61, and the placebo group −0.42. On a disease activity score (DAS28-CRP, where a score below 2.6 is considered very low disease activity), 34.1% of the filgotinib 200 mg group reached that level at week 12, compared with 23.8% (100 mg), 23.7% (adalimumab), and 9.3% (placebo). X-ray scores measuring joint damage at 24 weeks showed average changes of 0.13 (filgotinib 200 mg), 0.17 (100 mg), 0.16 (adalimumab), and 0.37 (placebo) on a scale where smaller numbers indicate less change. A quality-of-life physical score (SF-36 PCS, where higher is better) improved by an average of 9.2 points in the filgotinib 200 mg group, 8.5 points in the 100 mg group, 8.4 points in the adalimumab group, and 5.8 points in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02886728 · results posted 15 January 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT02886728) enrolled 1,252 people with rheumatoid arthritis across four groups: 417 received filgotinib 200 mg combined with methotrexate (MTX), 207 received filgotinib 100 mg combined with MTX, 210 received filgotinib 200 mg on its own, and 418 received MTX on its own. The trial was primarily measuring how many participants in each group showed at least a 20% improvement in standard rheumatoid arthritis signs and symptoms (known as an "ACR20 response") after 24 weeks. Several secondary measures were also tracked, including physical function, joint damage on X-ray, quality of life, and fatigue. The reported data shows that at week 24, the ACR20 response rate — the main measure — was 81.0% in the filgotinib 200 mg plus MTX group, 80.2% in the filgotinib 100 mg plus MTX group, 78.1% in the filgotinib 200 mg alone group, and 71.4% in the MTX alone group. For the secondary measures, the reported data shows that scores on a physical function questionnaire (HAQ-DI, where a more negative change means less difficulty) changed by −0.94, −0.90, −0.89, and −0.79 respectively across the four groups. The proportion of participants whose overall disease activity score (DAS28-CRP) fell below a low threshold of 2.6 was reported as 54.1%, 42.5%, 42.4%, and 29.1%. Changes in joint damage on X-ray (mTSS score, where a higher positive number means more damage progression) were reported as 0.21, 0.22, −0.04, and 0.51. Quality-of-life scores (SF-36 physical component, where higher is better) improved by 12.3, 11.1, 10.4, and 9.7 points, and fatigue scores (FACIT-Fatigue, where higher is better) changed by 10.6, 11.4, 10.2, and 10.1 points across the four groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02873936 · results posted 15 January 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT02873936) enrolled 449 adults across three groups: 148 received filgotinib 200 mg, 153 received filgotinib 100 mg, and 148 received a placebo (a dummy treatment with no active ingredient). The trial was measuring whether filgotinib — taken daily by mouth — could reduce the signs and symptoms of rheumatoid arthritis over 12 to 24 weeks, using a range of standard scoring tools that assess things like joint tenderness and swelling, physical function, fatigue, and quality of life. The reported data shows that by week 12, the percentage of participants whose joint disease showed at least a 20% improvement (a standard measure called ACR20) was 66.0% in the filgotinib 200 mg group, 57.5% in the filgotinib 100 mg group, and 31.1% in the placebo group. For a separate disease activity score (DAS28-CRP, a combined measure of joint counts and a blood marker of inflammation), 40.8%, 37.3%, and 15.5% of participants in each respective group reached a low-disease-activity threshold by week 12; and by week 24, 30.6%, 26.1%, and 12.2% reached an even lower "remission-range" threshold. The reported data also shows improvements from the starting point in physical function scores (HAQ-DI), physical quality-of-life scores (SF-36 physical component), and fatigue scores (FACIT-Fatigue) across all three groups at week 12, with larger average changes reported in the filgotinib groups than in the placebo group; specific starting and change figures for each group are included in the full trial record. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01894516 · results posted 19 November 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT01894516) enrolled 283 people with rheumatoid arthritis across four groups: one group received a placebo (dummy treatment), and three groups received different once-daily doses of a drug called GLPG0634 — either 50 mg, 100 mg, or 200 mg. The trial ran for 24 weeks. For the first 12 weeks, all four groups ran side by side. After week 12, participants who had been on placebo were switched across to one of the GLPG0634 doses, so the placebo group was not included in the week 24 comparisons. The main thing being measured was a standardised rheumatology scoring system called ACR20 — broadly, whether a participant showed at least 20% improvement across several markers of joint disease activity, including swollen and tender joint counts, pain scores, and a blood marker of inflammation (CRP). The reported data shows that at week 12, the percentage of participants who met the ACR20 response threshold was 29.2% in the placebo group, compared with 66.7% in the 50 mg group, 65.7% in the 100 mg group, and 72.5% in the 200 mg group. At week 24 (placebo group no longer included), the reported ACR20 response figures were 56.9% for the 50 mg group, 78.6% for the 100 mg group, and 66.7% for the 200 mg group. For a stricter measure requiring at least 50% improvement (ACR50) at week 12, the reported figures were 1.4% (placebo), 15.3% (50 mg), 18.6% (100 mg), and 23.2% (200 mg). An even stricter measure requiring 70% improvement (ACR70) at week 12 showed 1.4% (placebo), 8.3% (50 mg), 5.7% (100 mg), and 11.6% (200 mg). The reported data also shows results from a joint disease activity score called DAS28-CRP, which classifies responses as "none," "moderate," or "good." At week 12, the percentage of participants recorded as having a "good" response was 1% in the placebo group, 3% in the 50 mg group, 6% in the 100 mg group, and 7% in the 200 mg group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01888874 · results posted 17 November 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT01888874) enrolled 594 people across seven groups to study different doses of an investigational medicine called GLPG0634 compared to a placebo (a dummy treatment with no active ingredient) in people with rheumatoid arthritis. Participants were split into groups receiving either placebo or one of six different doses or dosing schedules of GLPG0634 over up to 24 weeks. The main thing the trial was measuring was the proportion of participants who showed at least a 20% improvement across several standard rheumatoid arthritis disease measures (known as an "ACR20 response") at 12 weeks. A range of similar measures were also tracked over the full 24 weeks. The reported data shows that at 12 weeks, 44.2% of participants in the placebo group met the ACR20 response threshold, compared with figures ranging from 56.1% to 78.6% across the various GLPG0634 dose groups. At 24 weeks, the placebo group's figure was 41.9%, while the GLPG0634 groups ranged from 54.9% to 79.8%. For the stricter 50% improvement threshold (ACR50) and 70% improvement threshold (ACR70), the reported percentages were considerably lower across all groups at the early time points, with some figures for later time points not fully reported in the submitted data. A broader measure of overall symptom improvement (called ACR-N, a score from 0 to 100 where higher means less severe symptoms) showed figures at Week 1 ranging from around 9 to 17.6 across groups, rising over time. Disease activity category assessments were also reported across multiple time points, though complete figures across all groups and all time points were not available in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01638013 · results posted 23 October 2020

    According to the results reported on ClinicalTrials.gov, this long-term extension trial enrolled a total of 843 adults across three groups — 201 who had previously completed an earlier trial called RAJ1, 225 from a trial called RAJ3, and 417 from a trial called RAJ4. All participants had rheumatoid arthritis and continued taking the study drug (upadacitinib) for an extended period, up to around week 372 (roughly seven years). The trial was measuring how many participants experienced any unwanted medical events (called adverse events), as well as tracking changes in joint symptoms over time using standard rheumatology scoring tools. The reported data shows that, for the primary outcome of adverse events, the numbers were high across all three groups — 193 out of 201 participants in the RAJ1 group, 208 out of 225 in the RAJ3 group, and 395 out of 417 in the RAJ4 group reported at least one adverse event. The data also shows that 0, 1, and 1 participant in each group respectively experienced a fatal adverse event; the remaining breakdown figures were also reported but a full category-by-category breakdown was not included in the submitted data. For the secondary outcomes, the reported data shows the percentage of participants whose joint symptoms improved by at least 20%, 50%, or 70% (known as ACR20, ACR50, and ACR70 scores — standard ways researchers measure joint improvement in rheumatoid arthritis trials). At the end of the study period, the RAJ3 and RAJ4 groups — who had been on the treatment longer before entering this extension — reported higher response percentages, for example around 82–86% for the ACR20 measure, compared to lower percentages in the RAJ1 group at earlier time points. The RAJ1 group's figures appeared to increase over time across the study, reaching around 64% by later time points, though not all time-point data was fully reported in the submission. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03449758 · results posted 10 August 2020

    According to the results reported on ClinicalTrials.gov, this trial enrolled 84 people who had been diagnosed with rheumatoid arthritis (a condition where the immune system attacks the joints). All participants received the study medicine, sarilumab. By the end of the study, 65 people completed it and 19 did not. The trial was measuring how much the disease affected participants' day-to-day lives over 24 weeks, using several questionnaires that asked people to rate things like pain, tiredness, sleep, mood, and ability to function. The reported data shows that the main (primary) thing being measured was a questionnaire called the RAID score — a scale from 0 (not affected at all) to 10 (most severely affected). At the start of the study, participants' average RAID score was 4.6. The reported data shows an average change of −1.2 points at week 4, −1.8 points at week 12, and −2.4 points at week 24, meaning scores moved lower (towards less impact) over time. For anxiety and depression, participants were given a separate questionnaire scored from 0–21. Anxiety scores started at an average of 8.1 and were reported as 6.6 at week 24; depression scores started at 7.0 and were reported as 5.5 at week 24. A third questionnaire measuring mood-related states (scored 0–200) started at an average of 88.4 and was reported as 90.9 at week 24; the data for this measure did not show a consistent directional change across time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02955212 · results posted 6 August 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT02955212) enrolled 338 adults with rheumatoid arthritis — 169 in each group. In the first part of the trial (12 weeks), one group received a placebo (an inactive treatment) and the other received upadacitinib 15 mg daily. Neither participants nor their doctors knew who was getting which treatment during this phase. Afterwards, both groups moved into an open-label extension phase where everyone received upadacitinib 15 mg. The trial was primarily measuring how many participants showed at least a 20% improvement in joint tenderness, joint swelling, and several other disease markers by week 12 — a standard benchmark known as an "ACR20 response." The reported data shows that by week 12, 71.6% of participants in the upadacitinib group met the ACR20 response threshold, compared with 31.4% in the placebo group. For the secondary outcomes, a disease activity score (rated 0–10, where higher means more active disease) fell by an average of 2.56 points in the upadacitinib group and 0.95 points in the placebo group. A questionnaire measuring everyday physical difficulties (scored 0–3, where higher means more difficulty) dropped by an average of 0.62 points in the upadacitinib group and 0.18 points in the placebo group. A general physical wellbeing score (where higher is better) rose by an average of 8.93 points for upadacitinib and 3.36 points for placebo. The reported data also shows that at week 12, 46.2% of participants in the upadacitinib group reached a "low disease activity" threshold on the disease activity scale, versus 13.6% in the placebo group. Additionally, 29.6% of the upadacitinib group reached a "remission" threshold on the same scale, compared with 5.3% in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04079114 · results posted 30 June 2020

    According to the results reported on ClinicalTrials.gov, this trial followed 166 people who received a hip implant called the Stafit Acetabular System — a cup-shaped component used in hip replacement surgery. The trial was measuring how well the implant stayed in place over time, including whether any implants needed to be removed or replaced, whether any dislocated (slipped out of position), and how participants felt in terms of pain and day-to-day movement. It is worth noting that the data shows zero participants were recorded as having "completed" the study, and all 166 were listed as "not completed," which may reflect how the study's milestones were defined rather than participants dropping out — however, the outcome results were still reported. The reported data shows that 100% of implants survived without needing to be revised or removed, and zero dislocations (cases where the implant slipped out of position) were recorded. For the secondary outcomes, participants' pain and physical function were measured using a scoring tool called the Harris Hip Score, where 0 is the worst possible result and 100 is the best. The reported data shows an average score of 91.5 out of 100 across the group. Separately, when counting the number of participants who experienced any implant-related complication (including dislocations, revisions, or removals), the reported figure was 1 person out of the 166 in the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03086343 · results posted 4 June 2020

    According to the results reported on ClinicalTrials.gov, this trial enrolled a total of 656 participants across four groups, all of whom had rheumatoid arthritis. The main groups were people taking upadacitinib (15 mg once daily) or abatacept — two different medicines used in arthritis — with some participants later switching between treatments. The trial was primarily measuring changes in joint disease activity over time using a scoring system called the DAS28-CRP, which runs from 0 to roughly 10, where a higher number means more active disease. A lower score or a drop in score suggests less disease activity. The reported data shows that, at 12 weeks, participants in the upadacitinib 15 mg group had an average drop in their DAS28-CRP score of 2.52 points from where they started, while those in the abatacept group had an average drop of 2.00 points. The reported data also shows that 30.0% of participants in the upadacitinib 15 mg group reached a score below 2.6 — a threshold the researchers described as "clinical remission" (meaning very low disease activity on this particular scale) — compared with 13.3% of participants in the abatacept group. These figures describe what was measured and counted in this trial; they do not on their own tell us everything about how either medicine performs more broadly. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04018001 · results posted 10 April 2020

    According to the results reported on ClinicalTrials.gov, this trial looked at how people with a rheumatic condition used two formulations of the medicine tofacitinib in real-world practice — a modified-release (MR) version taken once daily and an immediate-release (IR) version. A total of 678 people were in the MR group and 379 in the IR group, and all participants completed the study period. The trial was not testing the medicine in a controlled experiment; instead, it tracked how people actually took their prescriptions over 12 months, looking at things like how consistently they filled their prescriptions, how long they stayed on the medicine, and whether they needed other medicines or higher doses. The reported data shows several patterns across both groups. When it came to staying on the medicine without a long gap or switching to something else, the average duration was about 243 days for the MR group and about 236 days for the IR group, out of a possible 360 days. For how consistently people had their medicine on hand (measured two different ways), one method — called the Medication Possession Ratio — gave average scores of 0.89 (MR) and 0.86 (IR), with roughly 80% of MR participants and 70% of IR participants reaching the "high adherence" threshold of 0.8 or above. A second method — called Proportion of Days Covered, which counts actual days the medicine was available over the full 360-day window — gave lower average scores of 0.63 (MR) and 0.62 (IR), with about 48% of MR participants and 38% of IR participants meeting the high-adherence threshold. Finally, when all six effectiveness criteria were combined (covering prescription consistency, no dose increases, no switch to other advanced therapies, no new disease-modifying drugs, and limited use of steroid medicines), about 33% of the MR group and 26% of the IR group met every criterion over the 12 months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02984943 · results posted 24 March 2020

    According to the results reported on ClinicalTrials.gov, this trial looked at hyperbaric oxygen therapy — a treatment where a person breathes pure oxygen inside a pressurised chamber — in 14 participants. Ten people completed the trial, while four did not finish. The trial was measuring how pain affected participants' sleep, using a questionnaire called the PSQ-3. This questionnaire asked people to rate three things on a scale of 0 to 10: how often pain stopped them from falling asleep, how often pain woke them in the morning, and how often pain woke them during the night. A score of 0 meant "never" and a score of 10 meant "always," so lower numbers represent less sleep disruption from pain. The reported data shows the following scores for the group receiving hyperbaric oxygen therapy. For trouble falling asleep due to pain, the reported score was 1.3 out of 10 at six weeks and 0.9 out of 10 at six months. For being woken by pain in the morning, the reported score was 1.1 at six weeks and 0.8 at six months. For being woken by pain during the night, the reported score was 1.1 at six weeks and 1.2 at six months. It is worth noting that no comparison group (such as a placebo group) was included in the reported data, so these numbers reflect only the one group of participants who received the treatment. The scores before the trial began were not reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02996500 · results posted 27 February 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT02996500) enrolled 269 people with rheumatoid arthritis across six groups. Participants were randomly assigned to receive either a placebo (an inactive treatment), an existing medicine called tofacitinib (10 mg, included as a reference point), or one of four doses of an investigational medicine called PF-06650833 (20 mg, 60 mg, 200 mg, or 400 mg). The trial ran for 12 weeks and was primarily measuring changes in a standard arthritis disease activity score called the SDAI — a combined score (ranging from 0 to 86) that takes into account tender and swollen joint counts, patient and doctor assessments, and a blood marker of inflammation. A lower score means less disease activity. The reported data shows that, for the main outcome at 12 weeks, the placebo group's SDAI score fell by an average of 13.87 points from their starting level. The four PF-06650833 dose groups saw average reductions of 21.71 points (20 mg), 22.83 points (60 mg), 24.77 points (200 mg), and 25.16 points (400 mg). For secondary outcomes, the reported data shows that at 12 weeks, around 26.5% of placebo participants reached a "low disease activity" score (SDAI ≤ 11), compared with figures ranging from roughly 42% to higher percentages across the PF-06650833 groups (complete figures for all PF-06650833 doses at week 12 were not fully reported in the submitted data). Remission rates (SDAI ≤ 3.3) at 12 weeks were low across all groups, with 2.9% in the placebo group (complete week-12 figures for all PF-06650833 doses were not reported in the submitted data). Not all participants completed the study — dropout rates varied by group, ranging from about 2% to roughly 26%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03001219 · results posted 29 January 2020

    According to the results reported on ClinicalTrials.gov, this trial tested an investigational medicine called RO7123520 in people with rheumatoid arthritis — a condition causing joint pain and swelling. The trial had two stages: a "proof of concept" phase, where 37 people received a placebo (a dummy treatment with no active ingredient) and 72 received RO7123520; and a longer "extension period," where 9 people were in the placebo-to-active group and 97 received RO7123520. The trial was measuring things like joint improvement, bone density, unwanted medical events, and whether participants' immune systems produced antibodies against the study medicine. The reported data shows that when it came to the main joint improvement measure — the proportion of participants achieving what is called an "ACR50 response" (meaning at least a 50% improvement across several joint and wellbeing measures) at 12 weeks — 16.2% of placebo participants reached this level, compared with 11.1% of those receiving RO7123520 at 810mg in the proof-of-concept phase, and less than 1–2% in the extension period groups. For unwanted medical events (any unfavourable health occurrence during the trial, whether or not related to the medicine), the reported figures ranged from 48.6% in the placebo group to 60–66.7% across the RO7123520 groups. The reported data also shows that 0% of participants tested developed antibodies against the study medicine. For bone mineral density of the spine, small numerical changes from baseline were reported across all groups, but the full set of figures for all time points was not completely reported for every group in the submitted data. For joint disease activity scores (standardised scales used to track how active rheumatoid arthritis is), the reported data shows starting scores and changes at 12 weeks were only fully provided for the placebo and the 810mg proof-of-concept group — baseline scores were similar between those two groups, and both showed reductions by week 12, with the placebo group reporting a somewhat larger numerical reduction on both scales than the RO7123520 group; figures for the extension period groups were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02820038 · results posted 18 January 2020

    According to the results reported on ClinicalTrials.gov, this trial enrolled 286 people in total across four groups. Participants had rheumatoid arthritis and were being treated with disease-modifying medicines (DMARDs — a type of medication used to manage arthritis). The trial compared different ways of providing written medicine information: standard Consumer Medicine Information (CMI) leaflets, a simplified "Drug Facts Box" format, and whether adding an online decision-support program called SMART made a difference. The main thing the trial was measuring was whether participants made what researchers called an "informed decision" about their medicines at six months — meaning their choice lined up with their personal values and they answered most knowledge questions correctly. The reported data shows that the percentage of participants classified as having made an informed decision at six months ranged across the four groups. In the standard CMI-only group, about 60% were classified this way; in the CMI plus SMART group, about 44%; in the Drug Facts Box-only group, about 49%; and in the Drug Facts Box plus SMART group, about 56%. For the secondary measures, knowledge scores (on a 0–100 scale) were similar across all four groups, ranging from about 82 to 84 out of 100. Scores reflecting participants' personal values about using medicines (on a scale of −15 to +15) ranged from about 5.5 to 6.3, all slightly above the midpoint. Satisfaction with medicine information (out of 17) ranged from about 12.4 to 13.0 across groups. Scores on two reading-comprehension tasks were also broadly similar across groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02831855 · results posted 4 December 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT02831855) involved people with rheumatoid arthritis and ran in two back-to-back phases. In the first open-label phase (where everyone knew what they were receiving), 694 participants took tofacitinib 11 mg extended-release tablets together with methotrexate for 24 weeks, and 623 of them completed that phase. Those who completed it then moved into a 24-week double-blind phase (where neither participants nor study staff knew who was getting which treatment), with 267 participants continuing on tofacitinib plus a methotrexate placebo (dummy pill), and 266 continuing on tofacitinib plus real methotrexate. The trial was primarily measuring changes in joint disease activity scores over the full 48-week period. The reported data shows results using a standard rheumatoid arthritis disease activity score called DAS28 (which combines counts of swollen and tender joints, a blood marker of inflammation, and the participant's own rating of how they felt — scored from 0 to 9.4, where higher means more active disease). For the primary outcome, change in this score from the start of the double-blind phase to week 48, the group taking tofacitinib plus the methotrexate placebo showed an average increase of 0.33 points, while the group taking tofacitinib plus real methotrexate showed an average increase of 0.03 points. For the secondary outcomes, similar patterns in score changes were reported at week 36 and week 48 across related disease activity measures (including different versions of the DAS28 score, and other composite scores called CDAI and SDAI — all of which combine joint counts and global assessments). Regarding the proportion of participants classed as having "low disease activity" at week 48, the reported data shows approximately 45% in the tofacitinib-plus-placebo group and approximately 50% in the tofacitinib-plus-methotrexate group met that threshold. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01526057 · results posted 19 November 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 220 people across three groups — 73 received a version of rituximab made by Pfizer, 74 received a version approved in the European Union (EU), and 73 received a version approved in the United States (US). The trial was designed to compare how these three versions of rituximab behaved in the body, specifically by measuring how much of the drug reached the bloodstream and how quickly. It was not designed to measure whether the drug treated any particular disease. By the end of the study, 64, 71, and 67 participants completed the trial in the Pfizer, EU, and US groups respectively. The reported data shows that the peak level of rituximab detected in the blood (the highest concentration reached after the dose was given) was 453 micrograms per millilitre in the Pfizer group, 422 in the EU group, and 430 in the US group. The total amount of drug exposure over time — a measure that captures how much of the drug was present in the body across the whole period after dosing — was reported as 213,000, 200,000, and 214,000 (in micrograms × hours per millilitre) for the Pfizer, EU, and US groups respectively. Secondary measures of drug exposure over shorter time periods showed broadly similar patterns across all three groups. The reported data also shows that a specific type of immune cell called a CD19+ B-cell was measured in participants' blood throughout the study; the lowest recorded count after dosing was 0.0 cells per microlitre in all three groups, meaning B-cell levels fell to zero at their lowest point in every group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02683421 · results posted 8 November 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 18 people in total across four groups. Five healthy volunteers received a lower dose (50 micrograms) of a radioactive imaging agent called Tc 99m tilmanocept, four healthy volunteers received a higher dose (200 micrograms), four people with rheumatoid arthritis (RA) received the lower dose, and five people with RA received the higher dose. All 18 participants completed the study. The trial was measuring whether this imaging agent would show up in joints affected by RA — essentially, whether a special scan could "light up" swollen or tender joints — and how the signal compared between people with RA and healthy volunteers. The reported data shows that for the primary outcome — how many joints the imaging agent was detected in — the healthy volunteers recorded zero joints with visible accumulation of the agent at all time points. By contrast, the RA participants receiving the lower dose had 30 joints identified as swollen or tender by clinical assessment, with 1 to 2 of those showing up on imaging. The RA participants on the higher dose had 35 clinically identified joints, with 7 to 9 appearing on the scans. For the secondary outcomes, the reported data shows that the signal intensity in the joints of RA participants (around 1.13–1.21 on a voxel intensity scale) was slightly higher than in healthy volunteers (around 0.96–1.00). When comparing the signal to background levels in surrounding tissue, RA participants on the higher dose showed the largest difference from background — around 9% to 16% above background — while healthy volunteers showed slight negative values, meaning their readings were at or slightly below background levels. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02858492 · results posted 1 November 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT02858492) enrolled 51 people across four groups: 3 received a placebo twice daily (BID), 15 received a placebo three times daily (TID), 5 received the investigational medicine GSK2982772 at 60 mg twice daily, and 28 received GSK2982772 at 60 mg three times daily. The trial was primarily measuring a range of safety and tolerability markers — including unwanted medical events (called adverse events), blood and urine test results, and heart rhythm readings — rather than measuring whether the treatment reduced disease symptoms. The reported data shows that when it came to unwanted medical events, 3 out of 3 placebo-BID participants, 10 out of 15 placebo-TID participants, 3 out of 5 GSK2982772-BID participants, and 16 out of 28 GSK2982772-TID participants experienced at least one non-serious adverse event. Serious adverse events (those involving hospitalisation, life-threatening situations, or similar) were reported in 2 participants in the GSK2982772-TID group and none in the other three groups. For blood chemistry and blood cell count tests, no participants in any group reached the pre-defined levels of concern, with the exception of 2 participants in the GSK2982772-TID group who had one blood chemistry reading of potential concern. Urine tests showed some increases from starting levels across all groups, with the highest counts in the GSK2982772-TID group. Heart rate changes from the starting measurement were small across all groups, ranging roughly from about −6 to +7 beats per minute at various time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02628028 · results posted 9 October 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT02628028) tested an investigational medicine called LY3337641 in people with rheumatoid arthritis. The trial ran in two parts. Part A was a smaller safety-focused stage involving 36 participants, split across a placebo group and three dose groups (5 mg, 10 mg, and 30 mg). Part B was a larger stage involving 250 participants, again split across a placebo group and the same three dose groups. The trial was measuring, among other things, how many people experienced unwanted medical events in Part A, and in Part B, how many people showed meaningful improvements in their joint symptoms using a standard rheumatoid arthritis scoring system. The reported data shows that in Part A, the number of participants who experienced a treatment-related unwanted medical event was small across all groups (3 in the placebo group, 1 in the 5 mg group, 6 in the 10 mg group, and 2 in the 30 mg group); no serious events or special skin-related events were reported in any group. In Part B, the main outcome measured was whether participants achieved at least a 20% improvement in joint symptoms (a standard benchmark called ACR20). According to the results reported on ClinicalTrials.gov, the percentage of participants reaching this benchmark was 48.1% in the placebo group, 55.4% in the 5 mg group, 44.2% in the 10 mg group, and 50.9% in the 30 mg group. For a higher improvement threshold of 50% (ACR50), the reported figures were 27.8% (placebo), 25.0% (5 mg), 15.4% (10 mg), and 29.1% (30 mg). For the highest threshold of 70% improvement (ACR70), figures were 16.7% (placebo), 8.9% (5 mg), 1.9% (10 mg), and 16.4% (30 mg). A separate disease activity score (rated on a scale where lower numbers mean less active disease) also showed reductions across all groups, ranging from −1.24 to −1.80 points for the LY3337641 groups and −1.62 points for the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02629159 · results posted 7 October 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT02629159) involved 1,629 participants across three groups: 651 received a placebo (an inactive treatment), 327 received adalimumab (an existing medicine for rheumatoid arthritis), and 651 received upadacitinib (the medicine being studied). The trial was measuring how these treatments compared in reducing the signs and symptoms of rheumatoid arthritis — a condition that causes painful, swollen joints — over periods of 12 and 26 weeks. The reported data shows that, at 12 weeks, 36.4% of placebo participants, 63.0% of adalimumab participants, and 70.5% of upadacitinib participants met a standard measure of joint improvement (at least 20% improvement across several joint and wellbeing scores, known as ACR20). For a stricter measure — the proportion of participants whose disease activity score fell into a "remission" range — the reported figures were 6.1% for placebo, 18.0% for adalimumab, and 28.7% for upadacitinib. On a disability questionnaire (scored 0–3, where lower is better), average scores improved by 0.28 points in the placebo group, 0.49 in the adalimumab group, and 0.60 in the upadacitinib group from where they started. The reported data also shows that, at 26 weeks, X-ray measurements of joint damage (scored 0–448, where lower is better) changed by an average of +0.92 in the placebo group, +0.10 in the adalimumab group, and +0.24 in the upadacitinib group from baseline — meaning all three groups showed very small average changes, with placebo showing the largest increase. For a higher bar of joint improvement at 12 weeks (at least 50% improvement, known as ACR50), 14.9% of placebo participants, 29.1% of adalimumab participants, and 45.2% of upadacitinib participants met this threshold. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02706951 · results posted 7 October 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT02706951) looked at upadacitinib compared to methotrexate in people with rheumatoid arthritis. The trial ran in two periods. In the first period, 216 participants were assigned to methotrexate, 217 to upadacitinib 15 mg, and 215 to upadacitinib 30 mg. In the second period, 302 participants continued or switched to upadacitinib 15 mg and 300 to upadacitinib 30 mg. The trial was measuring things like joint tenderness and swelling, overall disease activity scores, physical function, and quality of life — all assessed at 14 weeks. The reported data shows the following at the 14-week mark. For the main measurement used for US regulators — the proportion of participants whose joint counts and other markers improved by at least 20% — 41.2% of the methotrexate group, 67.7% of the upadacitinib 15 mg group, and 71.2% of the upadacitinib 30 mg group met that threshold. For the main measurement used for European regulators — the proportion reaching "low disease activity" on a standard scoring scale — the reported figures were 19.4%, 44.7%, and 53.0% respectively. The proportion recorded as reaching "clinical remission" on that same scale was 8.3%, 28.1%, and 40.5% across the three groups. The reported data also shows changes in several secondary measures at 14 weeks. On a disease activity score (ranging roughly 0–10, where lower is better), the average change from the starting score was −1.20 for methotrexate, −2.29 for upadacitinib 15 mg, and −2.61 for upadacitinib 30 mg. On a physical function questionnaire (0–3 scale, where lower means less difficulty), the reported average changes were −0.32, −0.65, and −0.73. On a general physical quality-of-life score (where higher is better), the average improvements reported were 4.32, 8.28, and 10.19 points respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02706847 · results posted 7 October 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 499 adults across four groups. Two groups received a dummy treatment (placebo) for the first 24 weeks before switching to upadacitinib (either 15 mg or 30 mg daily), while the other two groups received upadacitinib from the start at those same doses. The trial was studying upadacitinib as a treatment for rheumatoid arthritis — a condition that causes joint pain, swelling and stiffness. The main things being measured at 12 weeks were: how many participants had at least a 20% improvement across several markers of joint disease activity (called an ACR20 response), and how many reached a "low disease activity" level on a standard scoring tool (called DAS28-CRP). The reported data shows that at 12 weeks, around 28% of participants in the placebo group met the ACR20 response (meaning improvement of at least 20% across key joint measures), compared with about 65% in the 15 mg upadacitinib group and 56% in the 30 mg group. For the low disease activity measure, roughly 14% of placebo participants reached that threshold, compared with about 43% in the 15 mg group and 42% in the 30 mg group. Among the additional measures tracked, the reported data shows that the upadacitinib groups also had larger average reductions in the DAS28-CRP disease activity score and in a self-reported difficulty-with-daily-tasks score (HAQ-DI), as well as larger average improvements in a physical quality-of-life score (SF-36 PCS), compared with the placebo group. Around 12% of placebo participants met the stricter ACR50 response (50% improvement), versus roughly 34% and 36% in the 15 mg and 30 mg upadacitinib groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02675426 · results posted 7 October 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 661 people with rheumatoid arthritis across four groups. In the first phase (weeks 1 to 12), participants received either a placebo (dummy treatment), upadacitinib 15 mg, or upadacitinib 30 mg daily. The trial was measuring things like joint tenderness and swelling, overall disease activity scores, physical disability, and quality of life — all assessed at the 12-week mark. After week 12, participants continued into a longer follow-up phase lasting up to around five years, with some switching doses along the way. The reported data shows that for the main measures at week 12, 35.7% of people in the placebo group met a standard threshold for meaningful improvement in joint counts and other symptoms (known as ACR20), compared with 63.8% in the 15 mg group and 66.2% in the 30 mg group. For a separate main measure — reaching a "low disease activity" score on a 0–10 scale — 17.2% of the placebo group met that target, compared with 48.4% and 47.9% in the 15 mg and 30 mg groups respectively. The reported data also shows that disease activity scores fell by an average of about 1.0 points in the placebo group, versus around 2.2 and 2.3 points in the two upadacitinib groups. For the physical disability questionnaire (scored 0–3, where lower is better), average scores dropped by 0.25 in the placebo group and by about 0.54–0.59 in the upadacitinib groups. A quality-of-life physical score (where higher is better) rose by an average of 3.03 points with placebo and around 7.6–8.0 points with upadacitinib. Finally, 10% of the placebo group reached the "remission" threshold on the disease activity scale, compared with roughly 28–31% in the upadacitinib groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02706873 · results posted 4 October 2019

    According to the results reported on ClinicalTrials.gov, this trial compared three doses of a medicine called upadacitinib against methotrexate (an existing treatment) in people with rheumatoid arthritis. Overall, more than 1,000 people took part across two periods — the first running to about 48 weeks, and the second continuing to around five years. The main things being measured were: how many people showed meaningful reductions in joint tenderness and swelling at weeks 12 and 24, whether participants reached a low disease-activity score considered "remission," and whether X-rays showed less joint damage over time. The reported data shows the following numbers for the three groups compared in the main (global) analysis — methotrexate, upadacitinib 15 mg, and upadacitinib 30 mg. At week 12, the percentage of participants who reached the "ACR50" threshold (a standardised measure of at least 50% improvement in joint counts and other markers) was 28.3%, 52.1%, and 56.4% respectively. For a lower improvement threshold called ACR20 (at least 20% improvement), the figures were 54.1%, 75.7%, and 77.1%. At week 24, the proportion who reached the remission score on a disease activity scale (called DAS28-CRP, where a score below 2.6 is considered remission) was 18.5%, 48.3%, and 50.0%. The reported change in an X-ray-based joint damage score over 24 weeks was +0.67 for methotrexate, +0.14 for upadacitinib 15 mg, and +0.07 for upadacitinib 30 mg (where any number above zero means some progression was detected). Secondary measures included a disease activity score (DAS28-CRP) that changed by −1.85, −2.73, and −2.85 points from the start, and a self-reported physical function score (HAQ-DI, rated 0–3 where lower is better) that changed by −0.49, −0.83, and −0.86 points respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02937701 · results posted 28 August 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT02937701) enrolled 279 participants in each of two groups — one receiving ABP 710 (a medicine being assessed as a biosimilar, meaning it is designed to be a close copy of an already-approved medicine) and one receiving infliximab (the existing approved medicine). Participants had rheumatoid arthritis, and the trial was measuring how their joint symptoms responded over time using standard scoring tools. The study ran in two phases: the first 22 weeks compared the two groups directly, and from week 22 to week 50 some participants were switched between treatments to observe what happened. The reported data shows that the main thing being measured was whether participants achieved what is called an "ACR20 response" at week 22 — meaning their tender and swollen joint counts and several other markers each improved by at least 20% from where they started. According to the results reported on ClinicalTrials.gov, 68.1% of those in the ABP 710 group and 59.1% in the infliximab group met this threshold at week 22. For a higher level of improvement (at least 50%, or "ACR50") at week 22, the reported figures were 43.0% for ABP 710 and 36.2% for infliximab. For the highest level measured (at least 70% improvement, or "ACR70") at week 22, the reported figures were 24.0% for ABP 710 and 19.7% for infliximab. After week 22, when some participants were switched from infliximab to ABP 710, the reported ACR20 response rates across the three continuing groups ranged from approximately 62% to 75% at various time points, with broadly similar figures seen regardless of whether participants were switched or stayed on the same treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00476996 · results posted 12 August 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT00476996) enrolled 836 adults with rheumatoid arthritis across three groups during the main blinded phase: 277 received a placebo plus a standard non-biologic disease-modifying drug (DMARD), 277 received a lower dose of ocrelizumab (200 mg, given twice by drip) plus a DMARD, and 282 received a higher dose of ocrelizumab (500 mg, given twice by drip) plus a DMARD. The main blinded phase ran up to 48 weeks, after which 664 participants entered an open-label extension phase where everyone received the 500 mg dose. The trial's primary focus was measuring how many participants showed at least a 20% improvement in joint tenderness, joint swelling, and several other disease markers — a standard benchmark known as an "ACR20 response." The reported data shows that, at the first measured point during the blinded phase, 22% of the placebo group met the ACR20 improvement benchmark, compared with 42.2% in the lower-dose ocrelizumab group and 47.9% in the higher-dose group. At a later time point, those figures were reported as 19.5% (placebo), 48.7% (200 mg), and 50.7% (500 mg). For secondary measures, the reported data shows that a sustained, deeper level of improvement (ACR70 held for at least six months) was recorded in 1.8% of the placebo group, 4.0% in the 200 mg group, and 5.7% in the 500 mg group. A disease activity score reaching a "remission" threshold (a score below 2.6 on a 0–10 scale) was reported in 1.4% of the placebo group, 11.9% of the 200 mg group, and 12.1% of the 500 mg group at a later time point. Average disease activity scores fell from a starting point of roughly 6.4–6.5 across all groups, with the placebo group dropping by about 1.1 points and the higher-dose ocrelizumab group dropping by about 2.4 points by the later time point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02573012 · results posted 24 July 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 259 adults with rheumatoid arthritis — 131 in one group and 128 in another. All participants received a combination of two medicines: tocilizumab (a medicine given by injection) and prednisone (a steroid tablet). The key difference between the two groups was how prednisone was used: one group had their prednisone dose gradually reduced over time (the tapering group), while the other group kept their prednisone dose steady (the constant group). The trial's main goal was to measure how much joint disease activity changed over 24 weeks, using a scoring system called DAS28-ESR — a scale from 0 to 10 where higher numbers mean more active disease, and a falling score suggests improvement. The reported data shows that, on the primary measure (change in DAS28-ESR score from the start of the trial to week 24), the tapering-dose group had an average score increase of 0.538 points, while the constant-dose group had an average score decrease of 0.075 points. A rise in score indicates slightly more disease activity, while a fall indicates slightly less. For a secondary measure called "treatment success" — defined as having low disease activity, no disease flare-up, and no significant adrenal gland problems by week 24 — 64.9% of participants in the tapering group and 77.3% in the constant-dose group met this definition. The reported data also shows that 26.0% of participants in the tapering group experienced at least one disease flare-up, compared with 10.9% in the constant-dose group. Among those who did have a flare-up, the average time to the first flare was reported as approximately 15.6 weeks in the tapering group and 12.1 weeks in the constant-dose group. On two further scoring measures of disease activity (CDAI scores), the reported data shows small average increases from baseline in both groups at week 24 — a rise of 2.663 points in the tapering group and 0.321 points in the constant-dose group — where any rise indicates a slight worsening on that scale. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02518620 · results posted 19 July 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 406 people in total across two groups: 257 participants received ALX-0061 (150 mg every two weeks) combined with methotrexate, and 149 received ALX-0061 alone. The trial was measuring joint symptoms in people with rheumatoid arthritis over roughly two years (104 weeks). The main things being tracked were standard rheumatology scoring systems that look at how many joints are tender or swollen, how much pain people report, how well they can perform daily tasks, and levels of inflammation in the blood. By the end of the study, 205 people in the combination group and 123 in the ALX-0061-alone group had completed the trial. The reported data shows that, when looking at the number of participants who met the threshold for at least a 20% improvement in joint counts and related measures (called an "ACR20 response"), the figures across both groups combined were 351 out of 350 analysed participants at week 12, moving to 335 at week 48 and 310 at week 104. For a stricter 50% improvement threshold (ACR50), the combined total was 262 at week 12, rising to 278 at week 48 and 271 at week 104. For the toughest threshold — a 70% improvement (ACR70) — the combined figures were 158 at week 12, 201 at week 48, and 225 at week 104. The reported data also shows an overall improvement index (a single combined score of percentage improvement) that sat at around 53% across both groups at week 12 and rose to around 74% by week 104. The reported data also tracked how participants' disease activity was categorised over time using two standard scoring tools (DAS28-ESR and DAS28-CRP, which combine joint counts, blood inflammation markers, and self-reported wellbeing into a single number). Across both groups combined, the number of participants whose scores fell into the lowest category (called "remission") was 152 at week 12 using the ESR-based score, rising to 209 by week 104; using the CRP-based score, 149 were in the lowest category at week 12 and 223 by week 104. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01878253 · results posted 15 July 2019

    According to the results reported on ClinicalTrials.gov, this trial looked at a stemless shoulder replacement implant called the Sidus Stem-Free Shoulder System. A total of 95 people were enrolled and followed over two years. The trial was measuring shoulder pain and function using a standard questionnaire (scored 0–100, where 100 is the best possible result), whether X-rays showed any signs of the implant failing or shifting, how long the implants lasted without needing to be revised or removed, and whether any serious problems directly related to the device occurred. The reported data shows that at the two-year mark, participants' average shoulder pain and function score (on the 0–100 scale) was reported as 89.4, with a margin of around 0.7. Before the operation, that same score was reported as 59.8, rising to 80.3 at six weeks, and 88.1 at one year. For the X-ray assessment at two years, the data reports that 83 out of the participants showed no signs of the implant failing or moving significantly, while 2 did show such signs. On survivorship — meaning the implant remaining in place without revision — 83 participants reached two years without a revision, while 3 did not. The reported number of serious adverse events directly linked to the device was zero. A general health questionnaire (the SF-12, scored 0–100 and adjusted so that 50 represents the population average) showed mental health scores staying close to 50 across all time points, while physical health scores were reported as rising from around 32.7 before surgery to 47.6 at two years — though the data as submitted does not clearly separate which scores belong to which time points for all entries. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02115750 · results posted 26 June 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT02115750) enrolled 647 adults in total — 323 received Enbrel (etanercept), a well-known rheumatoid arthritis medicine, and 324 received CHS-0214, a medicine designed to work in the same way as Enbrel (sometimes called a "biosimilar"). The trial ran in two parts: in Part 1, the two groups were compared over 24 weeks; in Part 2, all remaining participants received CHS-0214. The main thing being measured was the proportion of participants who reached a standard rheumatology benchmark called ACR-20 — meaning their swollen joint count, tender joint count, and several other disease measures each improved by at least 20% compared to where they started. The reported data shows that at the 24-week mark (the primary measurement point), 232 out of 323 participants in the Enbrel group and 233 out of 324 participants in the CHS-0214 group reached the ACR-20 benchmark. For the secondary measures taken at earlier time points, the reported percentages of participants reaching ACR-20 were: at week 4, 48.8% (Enbrel) vs 56.6% (CHS-0214); at week 8, 59.4% vs 71.1%; at week 12, 73.8% vs 74.6%; and at week 18, 75.0% vs 77.3%. The reported data also shows changes in the number of tender and swollen joints, scores on a physical difficulty questionnaire (HAQ-DI, scored 0–3), and self-reported pain scores (on a 0–100 scale) — all of which showed reductions from the starting point in both groups across the study visits. The size of those reductions was broadly similar between the two groups at most time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02198651 · results posted 25 June 2019

    According to the results reported on ClinicalTrials.gov, this trial looked at whether MRI scan scores of the hands and wrists could predict which people with rheumatoid arthritis might experience a "flare" (a return or worsening of symptoms) when their dose of adalimumab — a medicine used to treat rheumatoid arthritis — was reduced or stopped. A total of 149 people entered the first phase of the trial, where everyone received the standard dose of adalimumab. Of those, 112 completed that phase and moved on. In the next phase, 102 people were placed in a "tapering" group (gradually reduced dose) and 20 in a "withdrawal" group (medicine stopped). Some of those who experienced a flare then entered a rescue phase where they could receive the medicine again. The reported data shows that the three primary outcomes all used a statistical measure called an "odds ratio" — a way of expressing whether a higher MRI score was associated with a greater or lesser chance of having a flare. An odds ratio of exactly 1.0 would mean no association either way. For the measure of joint inflammation visible on MRI (synovitis), the reported odds ratio was 0.993; for bone swelling visible on MRI (bone marrow edema), it was 0.959; and for a combined score of both, it was 0.979. All three figures are very close to 1.0. For the secondary outcome of median time to flare in both the tapering and withdrawal groups, the data was not reported. Doctors and patients who experienced a flare rated its severity on a 0–10 scale; the reported data shows the number of participants who gave each rating, with small numbers spread across several score levels in both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02638948 · results posted 28 May 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT02638948) enrolled 247 people across four groups: 75 received a placebo (a dummy treatment with no active ingredient), 73 received BMS at a dose of 100mg, 73 received BMS at 200mg, and 26 received BMS at 350mg. The trial was measuring how many participants showed meaningful improvements in rheumatoid arthritis symptoms over 12 weeks, using a standardised scoring system that looks at things like joint tenderness, joint swelling, pain, and physical function. Not everyone completed the trial — 66, 62, 66, and 18 people respectively finished in each group. The reported data shows that the main thing measured was the percentage of participants who achieved at least a 20% improvement across several arthritis measures (called an ACR20 response) at 12 weeks. According to the results reported on ClinicalTrials.gov, the figures were: 30.7% in the placebo group, 35.6% in the 100mg group, 42.5% in the 200mg group, and 30.8% in the 350mg group. For a higher bar — at least 70% improvement (ACR70) — the reported figures were much lower across all groups: 4.0% (placebo), 4.1% (100mg), 9.6% (200mg), and 3.8% (350mg). A separate measure looked at the percentage of participants whose disease activity score fell into a remission range at week 12; the reported data shows 6.7% (placebo), 9.6% (100mg), 11.0% (200mg), and 0.0% (350mg) reached that threshold. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01856309 · results posted 6 May 2019

    According to the results reported on ClinicalTrials.gov, this trial involved 1,820 people in total across four groups. Participants had previously taken part in one of two related rheumatoid arthritis studies and were either receiving the drug sirukumab (at one of two doses — 50 mg every four weeks, or 100 mg every two weeks) or a placebo that was later switched to sirukumab. The trial was a long-term safety follow-up study, and its primary focus was on tracking a range of serious medical events — including serious adverse events broadly, major heart or stroke-related events, cancers, serious infections, bowel perforations, and liver or bile duct abnormalities. The reported data shows the following percentages of participants who experienced each type of event. For serious adverse events overall: 21.3% in the placebo-to-50 mg group, 27.8% in the placebo-to-100 mg group, 26.4% in the sirukumab 50 mg group, and 23.1% in the sirukumab 100 mg group. For major cardiovascular events (such as heart attack, stroke, or death): 2.0%, 0.7%, 2.3%, and 1.1% respectively. For cancers: 1.0%, 3.4%, 1.5%, and 1.8%. For serious infections: 7.9%, 12.0%, 10.4%, and 10.7%. For bowel perforations (a hole in the gut wall): 0.7%, 1.4%, 0.7%, and 0.5%. For liver or bile duct abnormalities: 0%, 0.3%, 0.2%, and 0.2%. It is worth noting that very few participants are recorded as having formally "completed" the study (fewer than 30 across all four groups combined), with the large majority recorded as not completing it — the reasons for this are not detailed in the reported data. The reported figures above reflect what was recorded across the time participants were in the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02504268 · results posted 8 April 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT02504268) enrolled 994 participants across its main starting groups — 451 people received a combination of abatacept and methotrexate (Cohort 1), 301 received a placebo alongside methotrexate (Cohort 1), and 242 received abatacept and methotrexate in a second cohort. The trial was designed to measure disease activity in people with rheumatoid arthritis over time, using several scoring systems that combine things like joint swelling, joint tenderness, a blood marker of inflammation (called CRP), and ratings from both the patient and doctor. The trial also looked at whether joint damage, visible on X-rays, changed over 52 weeks. The reported data shows that the main outcome — the proportion of participants reaching a very low disease activity score (called SDAI remission, meaning a score of 3.3 or below on a scale up to 86) at 24 weeks — was 21.3% in the abatacept-plus-methotrexate group (Cohort 1) compared with 16.0% in the placebo-plus-methotrexate group. At 52 weeks, the reported figures for the same remission measure were 29.8% versus 15.3% respectively. A separate remission measure (DAS28-CRP remission) at 24 weeks was reported as 38.7% in the combination group versus 25.3% in the placebo group. For a stricter definition of remission ("Boolean remission") at 52 weeks, the reported proportions were 21.5% versus 11.6%. The reported data also shows that average X-ray-based joint damage scores changed by 0.53 points in the abatacept-plus-methotrexate group compared with 2.52 points in the placebo-plus-methotrexate group over 52 weeks (on a scale of 0–448, where higher numbers mean more damage). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02321930 · results posted 19 March 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 25 people, all of whom received tofacitinib 5mg twice daily by mouth. Twenty-four participants completed the study, and one did not finish. The trial was measuring joint inflammation and disease activity in people with rheumatoid arthritis using several different scoring tools, each of which produces a number — a higher number on each scale means more disease activity at the time of measurement. The reported data shows the scores recorded at three separate time points across the study. For the Power Doppler ultrasound score (a way of detecting active inflammation in joints using sound waves, scored 0–90), the reported figures were 28.68, then 19.52, then 12.17. For the grey-scale ultrasound score (another ultrasound measure of joint swelling, also 0–90), the reported figures were 48.44, then 44.88, then 37.92. For the Clinical Disease Activity Index (a combined score of tender joints, swollen joints, and patient and doctor assessments, scored 0–76), the reported numbers were 39.88, then 28.60, then 21.63. For the DAS28/ESR (a widely used disease activity score incorporating joint counts, a patient rating, and a blood inflammation marker, scored 0–9.4), the reported figures were 6.26, then 5.23, then 4.56. The reported data also includes one secondary measure: the Multi-Biomarker Disease Activity blood test (a laboratory test using 12 biological markers to score disease activity from 1–100). The reported figures for this measure across the three time points were 50.56, then 40.96, then 39.63. The data as submitted does not specify exactly when each time point was measured, and no comparison group without the treatment was included in the reported results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01123655 · results posted 19 March 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT01123655) tested a drug called APL (also referred to as APLA-12) in people with rheumatoid arthritis. Participants were split into three groups: one receiving a lower dose (30 micrograms per day), one receiving a higher dose (50 micrograms per day), and one receiving a placebo (a dummy treatment with no active ingredient). A total of 22 people started the trial — 10 in the lower-dose group, 4 in the higher-dose group, and 8 in the placebo group — and 19 completed it. The main thing the trial was measuring was whether the treatment produced a change of more than 25% in a specific immune system signal (a protein called IFN) related to the body's response to a type of joint tissue, after 16 weeks. The reported data shows that, for the main outcome, 9 out of the 14 participants who received either dose of APL met the threshold for that immune system change, compared with 4 out of 8 participants in the placebo group. For one of the secondary measures — a disease activity score called the CDAI (where lower numbers suggest less active disease) — the APL group started at around 10.0 and was reported at around 9.9 at 16 weeks, while the placebo group started at around 10.3 and was reported at around 12.8 at 16 weeks. Various immune cell types and chemical markers in the blood were also measured; the reported data shows a range of changes in both the APL and placebo groups across these measures, though the data as submitted does not consistently label which specific cell type or chemical each individual number corresponds to, so those figures cannot be described in full detail here. The reported data also shows changes in certain antibody levels (IgG and IgA) and in a routine blood cell measurement called neutrophil count, with small differences noted between the APL and placebo groups at 16 weeks. It is worth noting that this was a very small trial, and the numbers of participants in each group were quite low. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01877239 · results posted 3 December 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 111 people, all of whom were in a single group receiving the medication etanercept. Of those, 76 were actually treated, 61 finished the full study, and 50 did not complete it. The trial was measuring disease activity in people with what appears to be rheumatoid arthritis, using a scoring tool called the Clinical Disease Activity Index (CDAI). The CDAI combines counts of swollen and tender joints with the patient's and doctor's overall ratings of how the disease is affecting the person, producing a total score between 0 and 76 — where a score of 2.8 or below is classed as "remission" (very low or no active disease), and higher scores indicate low, moderate, or high disease activity. The reported data shows that the main thing being measured was the proportion of participants whose CDAI score had reached remission (2.8 or below) at week 24. According to the results reported on ClinicalTrials.gov, 44.3% of participants met that remission threshold at week 24. Looking at earlier and later time points, the reported data shows that at week 12, approximately 22.4% were in remission, 50.0% had low disease activity, and 11.8% had moderate disease activity. By week 52, approximately 48.7% were in remission, 19.7% had low disease activity, and 7.9% had moderate disease activity. The reported data also shows changes in the average CDAI score from the starting point: the baseline average score was reported as 25.75, and this changed by approximately −19.09 points at week 12, −20.45 points at week 24, and −22.58 points at week 52, meaning the average score was lower at each of those time points compared with the start. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01941095 · results posted 13 November 2018

    According to the results reported on ClinicalTrials.gov, this trial (NCT01941095) enrolled 97 participants, all of whom received the medication tocilizumab. The trial was measuring disease activity in people with rheumatoid arthritis using a scoring system called DAS28-ESR — a number between 0 and 10 calculated from joint counts, a patient self-rating, and a blood test, where a higher number means more active disease and a score below 2.6 is considered "remission" (very low disease activity). Of the 97 who started, 41 completed the trial and 56 did not complete it. The reported data shows that at the 24-week mark — the trial's main measurement point — 40% of participants had a DAS28-ESR score below 2.6, meaning they were in the remission range at that time. Among those who then continued on tocilizumab alone (without other medicines), the percentage recorded in the remission range at follow-up time points between weeks 24 and 52 ranged from approximately 34% to 39% across those check-ins. For participants whose other arthritis medicines were intensified alongside tocilizumab after week 24, the percentage in remission or low disease activity at various points from weeks 28 to 52 ranged from roughly 1% to 10% across those time points. The reported data also shows that the overall DAS28-ESR score across all participants gradually decreased (improved) from baseline through to week 52, with the score dropping by about 1 point at week 4 and up to about 3.45 points by week 52 — a negative change indicating a lower disease activity score over time. The reported data also includes several other measures. Using a separate set of response categories called EULAR criteria, the percentage of participants recorded as having "no response" at weeks reported ranged from roughly 9% to 10%, while those with a "moderate response" ranged from about 21% to 45%, and those with a "good response" ranged from about 24% to 66%, varying across the different time points measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00838565 · results posted 2 November 2018

    According to the results reported on ClinicalTrials.gov, this trial involved 41 people in total, split across six groups. Nine participants received a placebo (a dummy treatment with no active ingredient), while the remaining 32 received different doses of an experimental drug called PF-04236921 — at doses of 1 mg, 10 mg, 30 mg, 100 mg, or 250 mg. The trial was primarily measuring how the drug behaved in the body at different dose levels (for example, how quickly it reached its peak level in the blood and how long it stayed there), as well as tracking any unwanted medical events (called adverse events) that occurred during the study, and whether participants' immune systems produced antibodies against the drug. The reported data shows that, when it came to unwanted medical events, all 9 participants in the placebo group experienced at least one such event, as did 4 out of 6 in the 1 mg group, 4 out of 6 in the 10 mg group, all 6 in the 30 mg group, all 6 in the 100 mg group, and 5 out of 7 in the 250 mg group. Serious adverse events — meaning events considered more significant, such as those requiring hospitalisation — were reported in 2 participants in the 30 mg group and 1 participant in the 100 mg group, with none reported in the other groups. Regarding antibodies produced against the drug, the reported data shows zero participants in any of the active treatment groups tested positive for these. For the blood-level measurements, higher doses were associated with higher peak concentrations of the drug in the blood — for example, the peak level on Day 1 was reported as approximately 422 ng/mL in the 1 mg group, rising to approximately 66,280 ng/mL in the 250 mg group — and similar patterns were seen at Day 28. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02748785 · results posted 4 October 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 277 participants across four groups (Group 1: 69, Group 2: 68, Group 3: 71, Group 4: 69). The trial was measuring how well participants' immune systems responded to a flu (influenza) vaccine, specifically looking at antibody levels — proteins the body produces that can help fight infection — against three flu strains: H1N1, H3N2, and B-Yamagata. Participants were followed across multiple visits, and by the final visit, the numbers who completed the trial were 53, 43, 47, and 50 in each group respectively. The reported data shows that for the primary measure — the proportion of participants showing a satisfactory immune response against all three flu strains at once — the percentages were 31.5% in Group 1, 22.7% in Group 2, 51% in Group 3, and 46.2% in Group 4. For the secondary measures, the proportion of participants reaching a "seroprotection" level (meaning their antibody levels reached a threshold considered potentially protective) against H1N1 was reported as 74%, 86%, 96%, and 86% across the four groups. Against H3N2, the figures were 100%, 96%, 98%, and 96%, and against B-Yamagata they were 72%, 71%, 94%, and 81%. The reported data also shows how much antibody levels changed from before to after vaccination (expressed as a fold change — for example, a fold change of 5 means levels were five times higher after vaccination than before). Against H1N1, the fold changes were 5.1, 5.0, 8.7, and 8.1 across the four groups. Against H3N2, they were 5.9, 6.1, 12.2, and 10.0. No fold change data for B-Yamagata was reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02843659 · results posted 4 October 2018

    According to the results reported on ClinicalTrials.gov, this trial (NCT02843659) tested two investigational treatments — an injection called BMS-931699/Lulizumab and a tablet called BMS-986142 — compared against a placebo (a dummy treatment with no active ingredient) in people with Sjögren's syndrome, an autoimmune condition that commonly causes dryness, pain, and fatigue. A total of 18 people started the trial: 5 in the injection group, 6 in the tablet group, and 7 in the placebo group. Very few participants finished the trial — only 1 in the injection group, none in the tablet group, and 2 in the placebo group completed it. The trial was designed to measure changes in two scoring systems: the ESSDAI (a doctor-assessed score of disease activity ranging from 0 to 123, where a lower score means less disease activity) and the ESSPRI (a patient-reported score of dryness, pain, and fatigue on a 0–10 scale). These were measured at several time points over 24 weeks. The reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of the primary or secondary outcome measures — meaning the actual scores and changes from baseline were not reported for any of the three groups. Given that the vast majority of participants did not complete the trial, it is likely the study was stopped early, though the specific reason was not provided in the data available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01705730 · results posted 4 September 2018

    According to the results reported on ClinicalTrials.gov, this trial (NCT01705730) enrolled 68 people, all of whom received a medicine called tocilizumab, which is used in the treatment of rheumatoid arthritis (a condition where the immune system attacks the joints). The trial was set up as a single group — there was no comparison group. Of the 68 people who started, 59 completed the study and 9 did not finish. The main thing the trial was measuring was how many participants were still taking tocilizumab six months after starting it. The reported data shows that 79.4% of participants were still on tocilizumab at the six-month mark. Regarding why people were enrolled in the first place, the reported data shows that 1 participant had been unable to tolerate other arthritis medicines (known as DMARDs), while 67 had not responded adequately to them. Separately, 35 participants had previously not responded adequately to other biologic medicines (a specific type of arthritis treatment). For those who had other arthritis medicines added during the study, the reported data shows the average time before that addition was 84 days. One secondary outcome — relating to how many participants had wider symptoms of rheumatoid arthritis at the start of the study — was listed but no numbers were reported for it. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00902486 · results posted 4 September 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 127 adults across four groups for the first 12-week period: 31 received a placebo (a dummy treatment with no active ingredient), and 32 received one of three daily doses of a drug called INCB028050 (4 mg, 7 mg, or 10 mg). The trial was looking at a condition affecting the joints — most likely rheumatoid arthritis — and was measuring two main things: how many participants reached a recognised standard of joint improvement called ACR 20 (meaning at least a 20% improvement across several joint and symptom measures), and how many participants experienced at least one unwanted side effect during the first 12 weeks. After week 12, participants who had been on placebo were switched to one of the active doses, and the trial continued to week 24. The reported data shows that at week 12, 10 out of 31 placebo participants reached the ACR 20 improvement threshold, compared with 16 out of 31 in the 4 mg group, 19 out of 32 in the 7 mg group, and 16 out of 30 in the 10 mg group. For side effects during those first 12 weeks, the reported data shows 19 out of 31 placebo participants experienced at least one adverse event, compared with 15 out of 31 (4 mg), 20 out of 32 (7 mg), and 23 out of 31 (10 mg). At the deeper improvement levels — ACR 50 (at least 50% improvement) at week 12 — the reported figures were 13% for placebo, 35% for 4 mg, 31% for 7 mg, and 30% for 10 mg. For ACR 70 (at least 70% improvement) at week 12, the figures were 3% for placebo, 16% for 4 mg, 9% for 7 mg, and 10% for 10 mg. By week 24, only the active-dose groups continued (no placebo comparison was available), and the reported ACR 50 figures were 33%, 37%, and 44% for the 4 mg, 7 mg, and 10 mg groups respectively; ACR 70 figures were 26%, 30%, and 28%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00785928 · results posted 10 July 2018

    According to the results reported on ClinicalTrials.gov, this trial tested a medicine called LY2127399 in people with rheumatoid arthritis (a condition causing joint pain and swelling). A total of 158 people took part in the treatment phase, spread across seven groups: one group received a placebo (a dummy treatment with no active medicine), and six groups received different doses of LY2127399 ranging from 1 mg up to 120 mg. The main thing the trial set out to measure was what proportion of participants showed a meaningful improvement — specifically, at least a 50% improvement across a standard set of joint and symptom measures — over 24 weeks. The reported data shows that, for this main measure (called ACR50), the percentages of participants showing that level of improvement were: 18.1% in the placebo group, 17.7% (1 mg), 17.0% (3 mg), 15.0% (10 mg), 11.8% (30 mg), 11.8% (60 mg), and 37.0% (120 mg). For a less strict measure of improvement (at least 20% improvement, called ACR20), the reported figures were 43.2% for placebo, rising to 70.1% for the highest dose group. The reported data also shows changes in the number of tender and swollen joints counted by a doctor, with all groups — including the placebo group — showing some reduction from their starting numbers over the 24 weeks. A standard overall disease activity score (where lower numbers mean less active disease) also showed reductions across all groups, ranging from −1.03 to −1.92 points on a scale of roughly 1 to 9. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01960855 · results posted 27 June 2018

    According to the results reported on ClinicalTrials.gov, this trial (NCT01960855) enrolled 276 people with rheumatoid arthritis across five groups. Fifty-six participants received a dummy treatment (placebo) twice daily, while the remaining 220 were split evenly across four groups receiving different twice-daily doses of an investigational drug called ABT-494 (3 mg, 6 mg, 12 mg, or 18 mg). The trial ran for 12 weeks and was primarily measuring how many participants showed a meaningful improvement in joint tenderness, joint swelling, and several other arthritis-related measures — a standard rheumatology scoring system known as an "ACR20 response" (meaning at least a 20% improvement across those measures). The reported data shows that, for the main measure at 12 weeks, 19 out of 56 placebo participants met the ACR20 response threshold, compared with 30 of 55 in the 3 mg group, 33 of 55 in the 6 mg group, 40 of 55 in the 12 mg group, and 39 of 55 in the 18 mg group. For the secondary measures — which looked at higher levels of improvement (50% and 70% thresholds) — the reported numbers were lower across all groups, as would be expected with a stricter bar. For the 50% improvement measure, the counts were 9 (placebo), 13, 20, 24, and 22 respectively; for the 70% improvement measure, they were 2, 7, 14, 12, and 12. The trial also tracked a separate disease-activity scoring system (DAS28), which combines joint counts, a blood inflammation marker, and general health into a single score. The reported data shows that 14 placebo participants reached the low disease activity or remission threshold, compared with 18, 20, 29, and 25 across the four ABT-494 dose groups. Looking at remission alone on that same scale, the counts were 7, 13, 14, 18, and 17. It is worth noting that not everyone who started the trial completed it — 11 placebo participants did not finish, compared with 4, 9, 4, and 5 across the ABT-494 groups. The results above used a standard method of filling in missing data for those who dropped out, which the trial team noted in their reporting. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02187055 · results posted 27 June 2018

    According to the results reported on ClinicalTrials.gov, this trial (NCT02187055) enrolled 1,146 people with rheumatoid arthritis across three groups: 384 received tofacitinib (5 mg twice daily) alone, 376 received tofacitinib combined with methotrexate, and 386 received adalimumab combined with methotrexate. By the end of the study, around 315, 303, and 312 people in each group respectively had completed the trial. The trial was primarily measuring how many participants reached a level of improvement in their joint and symptom scores — known as an "ACR50 response" — after six months. This means their tender and swollen joint counts, along with several other disease markers, had improved by at least 50%. The reported data shows that at the six-month mark, approximately 38% of participants in the tofacitinib-alone group, 46% in the tofacitinib-plus-methotrexate group, and 44% in the adalimumab-plus-methotrexate group met that 50% improvement threshold. The trial also measured changes in several disease activity scores over six months. The reported data shows reductions across all three groups in these scores, with the tofacitinib-plus-methotrexate group generally showing slightly larger numerical reductions. For example, one commonly used disease activity score (SDAI, which runs from 0 to 86 with higher numbers meaning more active disease) fell by around 24 points in the tofacitinib-alone group, 27 points in the tofacitinib-plus-methotrexate group, and 26 points in the adalimumab-plus-methotrexate group. The reported data also shows that a small proportion of participants in each group met a strict definition of remission (meaning very low or no detectable disease activity on all measures at once) at six months: approximately 8% in the tofacitinib-alone group, 9% in the tofacitinib-plus-methotrexate group, and 10% in the adalimumab-plus-methotrexate group reached this threshold. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01215942 · results posted 11 June 2018

    According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called LY2127399, tested in two dose groups — a 120 mg group and a 90 mg group. The trial was designed for people with rheumatoid arthritis, a condition causing joint pain and inflammation. In total, 414 people started the treatment period in the 120 mg group and 672 in the 90 mg group. The trial was measuring things like unwanted health events (called adverse events), whether the body developed antibodies against the medicine, changes in certain immune cells in the blood (called B cells), and how participants' arthritis symptoms responded over time. The reported data shows that during the treatment period, 259 out of 414 participants (120 mg group) and 422 out of 672 participants (90 mg group) experienced at least one treatment-emergent adverse event — meaning a health problem that appeared or got worse after starting the injections. Serious adverse events were recorded in 30 people in the 120 mg group and 57 in the 90 mg group. Regarding the body producing antibodies against the medicine, the reported data shows this occurred in approximately 1.7% of participants in the 120 mg group and 0.3% in the 90 mg group. B cell counts (a type of immune cell) fell on average by around 112 cells per microlitre in the 120 mg group and 121 cells per microlitre in the 90 mg group. For the secondary outcome measuring a 20% improvement in arthritis symptoms (called ACR20 response), approximately 42% of the 120 mg group and 46% of the 90 mg group met that threshold at one reported time point. The data for two other secondary outcomes — a disease activity score and a related response measure — were not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01202773 · results posted 14 May 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 456 adults across three groups: 153 received the higher dose of the investigational drug LY2127399 (120 mg), 148 received the lower dose (90 mg), and 155 received a placebo (a dummy treatment with no active ingredient). The trial was studying people with rheumatoid arthritis — a condition where the immune system attacks the joints — and the main thing it was measuring was whether participants' joint symptoms improved by at least 20% compared to where they started, using a standard rheumatology scoring system called ACR20. Secondary measures looked at greater levels of improvement (50% and 70%), as well as changes in the number of tender and swollen joints, self-reported pain scores, and other related measures. The reported data shows that for the main measure (ACR20 response at 24 weeks), 17.6% of participants in the 120 mg group, 24.3% in the 90 mg group, and 20.0% in the placebo group met that threshold. For the secondary measures of greater improvement, the reported data shows that around 7.2% (120 mg), 5.4% (90 mg), and 3.9% (placebo) reached the 50% improvement mark, and roughly 2.6%, 2.0%, and 0.6% respectively reached the 70% improvement mark. On the pain scale (rated 0–100, where lower means less pain), average scores changed by approximately −9.9 points in the 120 mg group, −9.2 in the 90 mg group, and −5.8 in the placebo group. Tender and swollen joint counts also shifted across all three groups, with the reported changes being relatively similar between the treated and placebo groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01198002 · results posted 8 May 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 1,041 adults with rheumatoid arthritis across three groups: 345 people received the higher dose of the study drug LY2127399 (120 mg), 347 received the lower dose (90 mg), and 349 received a placebo (a dummy treatment with no active ingredient). The trial was measuring three main things: how many people showed a meaningful improvement in joint tenderness, swelling, and other arthritis markers by week 24 (known as an ACR20 response); whether the drug slowed joint damage visible on X-rays by week 52 (measured using a joint damage scoring system); and whether people's ability to carry out daily activities improved by week 24 (measured using a self-reported questionnaire). The reported data shows that for the week 24 joint improvement measure, approximately 30% of participants in the 120 mg group, 33% in the 90 mg group, and 25% in the placebo group met the ACR20 response threshold. For the X-ray joint damage score (which runs from 0, meaning no damage, to 388, meaning maximum damage), the average change from the start of the trial to week 52 was reported as 1.43 points in the 120 mg group, 0.84 points in the 90 mg group, and 1.57 points in the placebo group — all small increases. For daily activity difficulty (scored 0 to 3, where lower is better), the reported average change from the start to week 24 was −0.26 in the 120 mg group, −0.30 in the 90 mg group, and −0.20 in the placebo group, indicating small reductions in reported difficulty across all groups. Secondary measures, including higher thresholds for joint improvement and overall disease activity scores, were also reported across all three groups, with the reported data showing modest differences between the drug and placebo groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01202760 · results posted 25 April 2018

    According to the results reported on ClinicalTrials.gov, this trial tested two doses of a medicine called LY2127399 (120 mg and 90 mg) against a placebo (a dummy treatment with no active ingredient) in people with rheumatoid arthritis. A total of 379 people started in the 120 mg group, 374 in the 90 mg group, and 251 in the placebo group. The main thing the trial was measuring was whether a certain proportion of participants showed at least a 20% improvement across a standard set of arthritis measures — a benchmark known as an "ACR20 response" — by 24 weeks. The reported data shows that for the primary measure (ACR20 response at 24 weeks), 34.4% of people in the 120 mg group, 33.5% in the 90 mg group, and 31.5% in the placebo group met that benchmark. For a higher bar of at least 50% improvement (ACR50), the reported figures were 11.6%, 11.7%, and 12.7% respectively, and for at least 70% improvement (ACR70), they were 4.7%, 6.3%, and 4.7%. The reported data also shows changes in the number of painful and swollen joints from the start to 24 weeks: tender joint counts changed by roughly -1.6 (120 mg), -1.6 (90 mg), and -2.1 (placebo), while swollen joint counts changed by -2.6, -3.2, and -3.6 respectively. On a pain scale of 0–100, participants reported average changes of -9.0 (120 mg), -9.6 (90 mg), and -6.9 (placebo) in their self-rated pain scores. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00837811 · results posted 25 April 2018

    According to the results reported on ClinicalTrials.gov, this trial (NCT00837811) looked at a medicine called LY2127399 in people with rheumatoid arthritis. It was an extension study, meaning participants had already taken part in one of two earlier related trials. A total of 182 people were enrolled across three groups, which differed by the dose they received: 60 people received a steady 60 mg dose, 121 people received a dose that varied between 60 mg and 120 mg, and 1 person was in a third dosing group. The trial's primary focus was on tracking unwanted medical events (called adverse events) and serious adverse events that occurred while participants were taking the study drug, as well as any unusual results from blood and urine tests. The reported data shows that, among those who experienced any unwanted medical event during treatment, 38 out of 60 participants were recorded in the 60 mg group, and 95 out of 121 in the 60/120 mg group. Serious adverse events were reported in 4 participants in the 60 mg group and 16 in the 60/120 mg group. Abnormal laboratory results reported as adverse events were very rare — only 1 participant in the 60/120 mg group during treatment, and 1 in the same group during the follow-up period. The reported data also shows changes in several secondary measures across groups. For the number of tender joints (out of 28 checked), the average change from the starting point was −9.2 joints in the 60 mg group and −6.5 joints in the 60/120 mg group. For swollen joints, the reported average change was −7.6 in the 60 mg group and −5.3 in the 60/120 mg group. On a 0–100 scale where participants rated their own arthritis activity, the average reported change was −26.1 mm in the 60 mg group and −16.7 mm in the 60/120 mg group. Physicians' ratings on the same type of scale showed average changes of −29.1 mm and −18.4 mm respectively. Results for the third dosing group (one participant only) are included in the submitted data but are not meaningful to describe given the very small number involved. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02046616 · results posted 13 April 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 133 people with rheumatoid arthritis (RA) who received tocilizumab, either on its own or combined with methotrexate or another disease-modifying drug. The trial ran for 24 weeks of treatment followed by an 8-week follow-up period. Of the 133 who started, 114 completed the treatment period and 113 completed the full follow-up. The trial was primarily measuring changes in a standard RA disease activity score called the CDAI (Clinical Disease Activity Index), which combines joint tenderness, joint swelling, and ratings from both the patient and their doctor, on a scale of 0 to 76 where higher numbers mean more active disease. The reported data shows that at the start of the trial, participants had an average CDAI score of about 24.9. By week 12 — the primary measurement point — the average score had fallen by 16.6 points. On the secondary measures, similar patterns were reported across other scoring tools. For example, a different disease activity score called DAS28-ESR (scale 0–10, higher meaning more active disease) started at an average of 5.0, and the reported change over the course of the study ranged from a drop of 1.4 points at the earliest time point to a drop of 3.3 points by the later time points. For the ACR response measure — which looks at the percentage of participants whose joint symptoms improved by at least 20%, 50%, or 70% — the reported figures varied across time points and thresholds, with some of the higher percentages reaching into the 80s. The EULAR response measure (another way of categorising disease activity change) reported that at certain time points, around 78% of participants fell into the "good" or "moderate" response categories, with roughly 5–9% showing no response, depending on the time point assessed. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01039688 · results posted 6 April 2018

    According to the results reported on ClinicalTrials.gov, this trial (NCT01039688) enrolled 956 people with rheumatoid arthritis across three groups: 373 received a lower dose of CP-690,550 (now known as tofacitinib) twice daily, 397 received a higher dose twice daily, and 186 received methotrexate once a week. The trial was measuring changes in joint damage visible on X-rays, how many participants experienced meaningful improvement in their arthritis symptoms, and blood pressure readings over time. Not everyone completed the trial — roughly 266, 286, and 106 people finished in each group respectively. The reported data shows that joint damage was tracked using a scoring system called the Modified Total Sharp Score (mTSS), where 0 means normal and 448 is the worst possible score. At the start of the trial, average scores across the three groups were around 19, 18, and 16 respectively. After six months, the reported change from those starting scores was +0.20 for the lower-dose group, +0.15 for the higher-dose group, and +0.65 for the methotrexate group — meaning all three groups showed very small increases on average. The trial also measured how many participants had a substantial improvement (at least 70% better) across several arthritis measures at six months: 25.4% in the lower-dose group, 37.3% in the higher-dose group, and 12.1% in the methotrexate group reached this threshold. For blood pressure, the reported changes from the starting point were very small across all three groups — generally less than 2 mmHg in either direction. At the 12- and 24-month marks, the reported mTSS scores remained relatively close to starting values across all groups, with the secondary outcome data showing scores continuing in a similar range to the six-month figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00413699 · results posted 27 March 2018

    According to the results reported on ClinicalTrials.gov, this trial looked at the long-term safety and tolerability of a medicine called tofacitinib in people with rheumatoid arthritis (a condition causing joint pain and inflammation). The trial had two phases: an initial period and a shorter extension period. In the initial period, 1,123 people received a lower dose (5 mg twice daily) and 3,358 received a higher dose (10 mg twice daily), making a total of 4,481 participants. A separate group of 48 participants took part in the extension period, receiving the 5 mg dose. The trial's main focus was on tracking unwanted medical events (called adverse events) and changes in laboratory test results over time. The reported data shows that during the initial period, across all participants combined, 4,154 out of 4,481 people experienced at least one treatment-emergent adverse event (an unwanted medical occurrence that appeared or worsened during treatment). The average age of participants was reported as around 61 years. During the extension period, 16 out of 48 participants experienced adverse events, and 5 experienced serious adverse events (those involving hospitalisation, life-threatening situations, or similar serious outcomes). Thirty participants in the extension period showed at least one abnormal laboratory test result. Approximately 31.3% of extension period participants had an adverse event, and around 4.2% stopped taking the medicine due to an adverse event, according to the reported figures. The reported data also shows results for a secondary measure — how much participants' rheumatoid arthritis symptoms improved. Using a standard scoring system (ACR20/50/70, which measures percentage improvement in joint tenderness, swelling, and related symptoms), around 70–78% of participants across the different dose groups and time points reached at least a 20% improvement in symptoms at various stages of the trial, with similar figures reported for 50% and 70% improvement thresholds. These figures varied depending on the dose group and the time point measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01665430 · results posted 8 February 2018

    According to the results reported on ClinicalTrials.gov, this trial (NCT01665430) enrolled 38 participants, all of whom received the medicine tocilizumab. Twenty-nine participants completed the study, while nine did not finish. The trial was measuring a range of things over roughly two years, including whether participants experienced any unwanted medical events (called adverse events), and how certain markers of joint disease activity changed over time — such as disease activity scores, the number of tender joints, and the number of swollen joints. The reported data shows that, when it came to unwanted medical events, 65.8% of participants experienced at least one adverse event of any kind, 34.2% experienced an adverse event of special interest (a pre-defined category covering things like infections, heart events, or allergic reactions), and 7.9% experienced a serious adverse event — meaning one considered significant, such as requiring a hospital stay. For the joint-related measures, the starting (baseline) disease activity score averaged 4.365 on a scale of roughly 0–10, and the reported data shows this score decreased (went down) by varying amounts at different time points throughout the study, with changes ranging from around −1.5 to −2.2. Similarly, the average number of tender joints at the start was 12.6 out of 28, with reported reductions of between roughly 5 and 10 joints at various points. The average number of swollen joints started at 4.8 out of 28, with reported reductions of between roughly 2 and 4.3 joints at various time points. The reported data also shows that 81.6% of participants reached what the trial defined as "clinical remission" — a disease activity score below 2.6 — at least once during the study. However, 0% of participants achieved what was called "drug-free remission," meaning no participant met the criteria for sustained low disease activity that would allow the medicine to be stopped. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01606761 · results posted 5 February 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 878 participants across its main groups. People were assigned to receive either a placebo (a dummy treatment with no active ingredient), or one of two doses of a medicine called sirukumab — either 50 mg given every four weeks, or 100 mg given every two weeks. The trial was measuring changes in rheumatoid arthritis symptoms, including joint swelling and tenderness, pain levels, physical function, and markers of inflammation in the blood. Some participants who started on placebo were later switched to one of the sirukumab doses partway through the study. The reported data shows that the main result — the proportion of people showing at least a 20% improvement in joint and symptom scores by week 16 — was 24.1% in the placebo group, 40.1% in the sirukumab 50 mg group, and 45.2% in the sirukumab 100 mg group. For a more stringent measure (at least 50% improvement by week 24), the reported figures were 8.8% for placebo, 20.9% for the 50 mg group, and 21.6% for the 100 mg group. The reported data also shows that the proportion of people whose overall disease activity score fell into a "remission" range by week 24 was 8.2% in the placebo group, 19.2% in the 50 mg group, and 21.6% in the 100 mg group. The reported data also includes a measure of how much difficulty people had with everyday physical tasks (such as dressing, walking, and eating), scored on a scale from 0 to 3. Starting scores were similar across all three groups (around 1.57 to 1.65). By week 24, the average change from those starting scores was reported as −0.12 for the placebo group, −0.31 for the 50 mg sirukumab group, and −0.33 for the 100 mg sirukumab group — meaning all groups reported some reduction in difficulty on average, with the sirukumab groups reporting a larger change. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01721044 · results posted 18 January 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 527 adults across three groups: 176 received a placebo (a dummy treatment with no active ingredient), 174 received a 2 mg daily dose of baricitinib, and 177 received a 4 mg daily dose of baricitinib. The trial was studying baricitinib as a treatment for rheumatoid arthritis — a condition causing joint pain and swelling. The main thing the trial measured was how many participants reached a standard benchmark called "ACR20," which means their joint tenderness, joint swelling, and several other arthritis-related measures all improved by at least 20%. The reported data shows that, for the primary outcome, 27.3% of participants in the placebo group reached the ACR20 benchmark, compared with 55.4% in the baricitinib 4 mg group. For the secondary outcomes, the trial also measured everyday physical function using a questionnaire scored from 0 (no difficulty) to 3 (most difficulty). The reported data shows the placebo group's score changed by −0.20 on average, the 4 mg group by −0.42, and the 2 mg group by −0.38 — where a lower (more negative) number means a greater reported change from their starting score. A broader measure of overall disease activity (scored roughly 1 to 9.4, where lower means less active disease) showed an average change of −0.85 in the placebo group and −1.81 in the 4 mg group. The proportion of participants whose disease activity scores fell into a "remission" category was reported as 1.7% for placebo and 5.1% for the 4 mg group. For the ACR20 measure comparing placebo to the 2 mg dose, 48.9% of the 2 mg group reached that benchmark versus 27.3% for placebo. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02480153 · results posted 26 September 2017

    According to the results reported on ClinicalTrials.gov, this trial (NCT02480153) enrolled 597 adults across two initial groups to compare PF-06410293 (a proposed "biosimilar" — a medicine designed to be very similar to an already-approved medicine) with adalimumab-EU (an existing approved medicine used for conditions such as rheumatoid arthritis). Over the course of the trial, participants moved through up to three phases spanning about 78 weeks. In some phases, people who had been receiving adalimumab-EU were switched across to PF-06410293, creating a third group. The main thing the trial was measuring was whether a certain proportion of participants showed at least a 20% improvement across several arthritis-related assessments — a standard research measure known as an "ACR20 response" — at week 12. The reported data shows that at week 12, approximately 68% of participants in the PF-06410293 group and approximately 71% of participants in the adalimumab-EU group met the ACR20 response threshold. For additional time points tracked through the first 26 weeks, the reported numbers of participants meeting the ACR20 threshold were broadly similar between the two groups at each check-in point. When some participants were switched from adalimumab-EU to PF-06410293 in the second and third phases, the reported data shows that the numbers of participants meeting the ACR20 threshold across all groups remained in a comparable range through to around week 78. Similar patterns were seen for a stricter measure — at least 50% improvement (called "ACR70 response" — wait, labelled here as ACR50) — with reported participant counts also tracked across the phases, again appearing broadly comparable across groups at each time point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02222493 · results posted 11 September 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled 324 participants in the PF-06438179 group (a biosimilar medicine) and 326 in the infliximab (brand name Remicade) group — a total of 650 people at the start. The trial ran across three periods covering roughly 78 weeks in total. Because participants were switched between treatments at certain points, the group numbers shifted across the three periods. The trial was measuring how many participants showed meaningful improvements in rheumatoid arthritis symptoms using a standard set of joint and wellbeing assessments, known as ACR response scores — essentially counting improvements in painful and swollen joints alongside other measures like pain ratings and physical function. The reported data shows that at the main measurement point (week 14), 198 out of 324 participants in the PF-06438179 group and 207 out of 326 in the infliximab group met the threshold for at least a 20% improvement across the required measures (called an ACR20 response). At earlier and later check-ins during the first 30 weeks, the numbers of participants meeting this same 20% improvement threshold ranged from around 105 to 210 in the PF-06438179 group and 121 to 214 in the infliximab group. The reported data also shows that when participants were switched from infliximab to PF-06438179 from week 30 onward, the numbers meeting the ACR20 threshold remained in a broadly similar range through to week 78, though the data was not reported in a way that allows straightforward before-and-after comparison for every individual. For the higher improvement thresholds (50% improvement, or ACR50), the reported numbers were lower across both groups, as would be expected. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01709578 · results posted 8 August 2017

    According to the results reported on ClinicalTrials.gov, this trial (NCT01709578) enrolled 546 adults with rheumatoid arthritis — 181 in a placebo group, 181 receiving a 150 mg dose of sarilumab every two weeks, and 184 receiving a 200 mg dose of sarilumab every two weeks. The trial was measuring two main things: how many participants showed at least a 20% improvement on a standard rheumatoid arthritis symptom checklist (called ACR20) by week 24, and how much participants' ability to carry out everyday tasks (measured on a scale called the HAQ-DI, where a lower score means less difficulty) changed by week 12. The reported data shows that by week 24, 33.7% of placebo participants met the ACR20 improvement threshold, compared with 55.8% in the 150 mg sarilumab group and 60.9% in the 200 mg sarilumab group. For everyday physical function at week 12, the placebo group's average score dropped by 0.26 points on the 0–3 scale, while the 150 mg group dropped by 0.46 points and the 200 mg group by 0.47 points (a larger drop indicates less difficulty reported). The reported data also shows results for several secondary measures at week 24. On a separate disease-activity score (DAS28-CRP, rated 2–10), average scores fell by 1.38 points in the placebo group, 2.35 points in the 150 mg group, and 2.82 points in the 200 mg group. For higher thresholds of symptom improvement (ACR50 and ACR70), the reported figures were: ACR50 — 18.2% (placebo), 37.0% (150 mg), 40.8% (200 mg); ACR70 — 7.2% (placebo), 19.9% (150 mg), 16.3% (200 mg). The percentage of participants whose disease-activity score fell into the "remission" range (below 2.6) was 7.2% (placebo), 24.9% (150 mg), and 28.8% (200 mg). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01764997 · results posted 27 July 2017

    According to the results reported on ClinicalTrials.gov, this trial involved people with rheumatoid arthritis and was designed to compare different treatments across two main stages. In the first stage (the "run-in" period), 776 participants started on a medicine called adalimumab; 738 of them completed this stage, while 38 did not. Those who moved into the second stage were randomly assigned to one of three treatment groups — etanercept plus methotrexate (17 people), sarilumab 150 mg plus methotrexate (13 people), or sarilumab 200 mg plus methotrexate (13 people) — alongside a separate open-label sub-study group of 322 participants receiving sarilumab 150 mg plus methotrexate. The trial was primarily measuring changes in joint disease activity (using a scoring system called DAS28-CRP, which combines information about tender and swollen joints and a blood marker of inflammation) over 24 weeks. The reported data shows that, unfortunately, no numerical results were submitted to ClinicalTrials.gov for any of the outcome measures listed — including the primary measure (change in disease activity score at week 24) and all of the secondary measures (such as the proportion of participants showing 20%, 50%, or 70% improvement in arthritis symptoms, and the proportion reaching a "remission" score, at weeks 12 and 24). Because no measurement data was provided in the submitted results, it is not possible to describe what the numbers showed for any of these outcomes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01750931 · results posted 17 July 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled 28 adults in total, split into two groups of 14. It was a crossover study, meaning every participant took both treatments at different times — one group took a GSK-branded version of meloxicam 15 mg first, then switched to the brand-name version called Mobic after a washout (a rest period to clear the drug from the body), while the other group did it in the opposite order. All 28 participants completed every stage of the trial. The trial was not measuring how well the medicine worked for any health condition; instead, it was measuring how the drug moved through the body — things like how much of the drug got into the bloodstream and how quickly. The reported data shows very similar numbers between the two versions of meloxicam across all the measurements taken. The peak level of the drug detected in the blood (the highest concentration reached after a single dose) was reported as approximately 1,890 nanograms per millilitre for the GSK version and approximately 1,844 nanograms per millilitre for the Mobic version. Both versions reached that peak level at the same time point — 5.5 hours after taking the dose. The total amount of drug absorbed over time (measured as the area under a concentration-time curve, which is a way of adding up drug levels across all time points) was reported as approximately 57,499 for GSK-meloxicam and approximately 54,751 for Mobic-meloxicam (in nanogram-hours per millilitre), with slightly higher figures when the calculation was extended to estimate full absorption. The time it took for the body to reduce the drug level by half was reported as approximately 21.4 hours for the GSK version and approximately 22.3 hours for the Mobic version. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01664104 · results posted 13 July 2017

    According to the results reported on ClinicalTrials.gov, this trial (NCT01664104) enrolled 136 adults with rheumatoid arthritis (a condition where the immune system attacks the joints). The study was measuring how many participants were still receiving a medicine called tocilizumab (TCZ) after six months of treatment. Of the 136 people who started, 120 completed the study and 16 did not finish. The reported data shows that 86.5% of participants who were assessed were still on tocilizumab treatment at the six-month mark. Among those who were still on the medicine at six months, the reported data shows that approximately 93.9% were on one particular dose level, with very small percentages (around 0.87–1.74% each) recorded at a handful of other dose levels. Regarding why participants had started tocilizumab in the first place, about 62.4% had previously not responded well enough to another type of biological medicine, while 37.6% had not responded well enough to, or could not tolerate, disease-modifying drugs (medicines commonly used to slow rheumatoid arthritis). The reported data also shows that, on average, participants had been living with a rheumatoid arthritis diagnosis for around 6.5 years before joining the study. At the start of the study (baseline), participants were asked to rate their pain and how they were managing their disease on a scale of 0 to 100. The reported data shows the average pain score was 61.3 out of 100, and the average score for how well they felt they were managing their disease overall was 61.0 out of 100 — both sitting in the higher (more difficult) range of those scales. These baseline figures describe how participants felt before the study period, and no comparative endpoint scores were reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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  • NCT01061736 · results posted 28 June 2017

    According to the results reported on ClinicalTrials.gov, this trial (NCT01061736) was conducted in two parts and involved people with rheumatoid arthritis. Part A enrolled 306 participants across five different doses of a medicine called SAR (sarilumab) and a placebo (a dummy treatment with no active ingredient), and was run over 12 weeks. Part B was a larger phase involving approximately 1,285 additional participants across three groups — two different doses of SAR given every two weeks, and a placebo — and ran for up to 52 weeks. The trial measured things like joint tenderness and swelling, participants' ability to carry out daily activities, and X-ray evidence of joint damage progressing over time. The reported data shows the following numbers from Part A at 12 weeks: the percentage of participants who met a standard measure of joint improvement (called ACR20, meaning at least a 20% reduction in certain joint and symptom scores) ranged from 49% to 72% across the SAR dose groups, compared with 46.2% in the placebo group. In Part B at 24 weeks, the reported ACR20 figures were 58% for the 150 mg every-two-weeks group, 66.4% for the 200 mg every-two-weeks group, and 33.4% for the placebo group. For daily physical function (scored on a scale where lower numbers mean less difficulty), the reported average change from the starting point at 16 weeks was a reduction of 0.54 points in the 150 mg group and 0.58 points in the 200 mg group, compared with a reduction of 0.30 points in the placebo group. For X-ray scores measuring joint damage progression over 52 weeks (on a scale of 0–448, where higher means more damage), the reported average change from baseline was 0.90 points in the 150 mg group, 0.25 points in the 200 mg group, and 2.78 points in the placebo group. Finally, the reported data shows that the percentage of participants who maintained a high level of joint improvement (ACR70) for at least 24 weeks in a row was 12.8% in the 150 mg group, 14.8% in the 200 mg group, and 3% in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01383421 · results posted 26 June 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled 1,025 people with rheumatoid arthritis (RA) who were all receiving the medication adalimumab. Of those, 679 completed the study and 346 did not. Participants were divided into two groups depending on whether they used a Patient Support Program (PSP) — a structured support service — or not. The trial ran for 78 weeks and was primarily measuring changes in participants' ability to carry out everyday tasks such as dressing, eating, walking, and gripping, using a self-reported questionnaire called the Health Assessment Questionnaire Disability Index (HAQ-DI). A meaningful improvement was defined as a score reduction of at least 0.22 points from the start of the trial (a lower score indicates less difficulty with daily tasks). The reported data shows that, at the 78-week mark (the main measurement point), 48.1% of PSP users and 37.8% of PSP non-users were recorded as having reached that meaningful improvement threshold in their daily functioning scores. At earlier time points, the reported figures were: at 12 weeks, 60.9% of PSP users and 50.0% of PSP non-users; at 24 weeks, 52.3% and 46.4%; at 36 weeks, 49.9% and 43.0%; at 52 weeks, 48.5% and 39.2%; and at 64 weeks, 48.3% and 37.3%. Across all time points reported, the PSP user group consistently recorded a higher percentage reaching the improvement threshold compared to the PSP non-user group. It is important to note that this trial did not include a comparison group of people who did not receive adalimumab at all, so the reported numbers reflect only what was measured within this one treatment group, divided by PSP use. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02433340 · results posted 19 June 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled 158 people in total across four groups, all of whom had rheumatoid arthritis. The trial was comparing different doses and dosing schedules of an investigational drug called ABT-122 against an existing medicine called adalimumab (ADA). Participants were randomly assigned to one of four groups: one group started on adalimumab and then switched to ABT-122 120 mg every other week; the other three groups received different doses or frequencies of ABT-122 from the start. The trial was measuring what is called an "ACR20 response" — a standard way of tracking whether a person's joint tenderness, joint swelling, and several other arthritis-related measures each improved by at least 20% compared to where they started. The reported data shows the percentage of participants in each group who met that ACR20 response threshold at six points in time: weeks 2, 4, 6, 8, 12, and 16. At the earliest check-in (week 2), reported response rates across all four groups ranged from about 43% to 47%. By week 4, the range had widened — from about 46% up to 74% — with differences visible between the groups. By weeks 8 and 12, reported response rates had risen further, with most groups sitting between approximately 70% and 85%. At the final measurement point of week 16, the reported rates ranged from roughly 78% to 86% across the four groups. The reported data shows a combined figure for all participants who received ABT-122 at the 120 mg every-other-week dose reaching approximately 82% by week 16. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01987479 · results posted 19 June 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled 150 people who were treated with tocilizumab — either on its own or combined with methotrexate or another disease-modifying drug — for rheumatoid arthritis. Of those 150 participants, 133 completed the study and 17 did not. The trial tracked any unwanted medical events that occurred during the study, as well as changes in rheumatoid arthritis disease activity over 24 weeks using several standard measurement tools used in arthritis research. The reported data shows that the primary thing measured was how many participants experienced any adverse event (that is, any unwanted medical occurrence during the study) — this was reported as 91.3% of participants. For disease activity, researchers used a scoring system called the DAS28-ESR (a combined score based on joint counts, a blood marker, and how participants rated their own condition, scored from 0 to 10 where higher means more active disease). The reported starting score was 4.8, and over the course of the study the score was reported to decrease — the reductions from the starting point grew from about 1.3 at week 2 up to around 3.2 at week 24. The trial also measured what proportion of participants reached certain improvement thresholds in joint swelling, tenderness, and other assessments. The reported data shows that by week 24, approximately 82.6% of participants reached a "20% improvement" threshold (ACR20), 62.0% reached a "50% improvement" threshold (ACR50), 35.5% reached a "70% improvement" threshold (ACR70), and 15.7% reached a "90% improvement" threshold (ACR90). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01721057 · results posted 12 June 2017

    According to the results reported on ClinicalTrials.gov, this trial (NCT01721057) looked at a medicine called baricitinib in people with rheumatoid arthritis — a condition where the immune system attacks the joints. A total of 684 people took part in the main treatment phase: 228 received a placebo (a dummy treatment with no active ingredient), 229 received a 2 mg daily dose of baricitinib, and 227 received a 4 mg daily dose. The trial's main goal was to measure how many participants reached a standard benchmark called "ACR20" — meaning at least a 20% improvement across a set of joint, pain, and function measures commonly used in arthritis research. The reported data shows that, for the primary measure, 39.5% of people in the placebo group reached the ACR20 benchmark, compared with 65.9% in the baricitinib 2 mg group and 61.7% in the baricitinib 4 mg group. For the secondary measures, the reported data shows changes in everyday physical function (scored on a scale of 0–3, where lower is better): the placebo group improved by 0.30 points on average, while both baricitinib groups improved by 0.52 points. A broader measure of disease activity (scored 1.0–9.4, lower being better) showed an average improvement of 1.05 points for placebo, 1.83 for the 2 mg group, and 1.91 for the 4 mg group. The reported data also shows that the percentage of people reaching a strict remission threshold on another disease activity score was 0.9% for placebo, 9.2% for the 2 mg group, and 8.8% for the 4 mg group. For morning joint stiffness, the placebo group reported an average duration of 60.0 minutes in the week before assessment, compared with 44.4 minutes for the 2 mg group and 34.6 minutes for the 4 mg group; severity ratings (on a 0–10 scale) were 4.2, 3.5, and 3.4 respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00346216 · results posted 1 May 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled 24,081 people in total across three groups: 8,072 took celecoxib, 8,040 took ibuprofen, and 7,969 took naproxen. All three are pain-relief medicines commonly used for arthritis. The trial was measuring and comparing three main things across the groups: the rate of serious heart and blood vessel events (such as heart attack, stroke, or cardiovascular death), the rate of serious stomach and bowel problems, and self-reported pain scores on a scale of 0 to 100. The reported data shows that for the primary measure — serious heart and blood vessel events — the percentages of participants who experienced at least one such event were 2.3% in the celecoxib group, 2.7% in the ibuprofen group, and 2.5% in the naproxen group. For a broader group of heart-related events (the secondary measure), the reported figures were 4.2%, 4.8%, and 4.3% respectively. For serious stomach and bowel events, the reported data shows 0.7% for celecoxib, 0.9% for ibuprofen, and 0.7% for naproxen. Regarding self-reported pain (on a 0–100 scale where higher means more pain), all three groups started with an average score of around 54. Over time, all three groups reported lower pain scores than at the start, with reductions ranging from roughly 8 to 12 points depending on the group and the time point measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01500278 · results posted 31 March 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled 457 people in the certolizumab pegol plus methotrexate group (CZP+MTX) and 458 people in the adalimumab plus methotrexate group (ADA+MTX) — a total of 915 participants. The trial was comparing these two medication combinations in people with rheumatoid arthritis, tracking them over roughly two years (104 weeks). The main things being measured were how many participants showed a meaningful improvement in joint tenderness, swelling, and related symptoms by week 12, and how many reached a low level of disease activity (based on a standardised scoring system) by week 104. The reported data shows that at week 12, around 69.2% of the CZP+MTX group and 71.4% of the ADA+MTX group met the target improvement threshold (known as ACR20 — meaning at least a 20% improvement across several joint and symptom measures). By week 6, those figures were 64.5% and 60.8% respectively. For the disease activity score (a combined measure of joint counts, a blood marker, and patient-reported wellbeing, where a lower score means less active disease), the reported data shows that at week 6, about 20.5% of the CZP+MTX group and 18.1% of the ADA+MTX group reached the low-activity threshold; by week 12 those figures were 30.4% and 29.7%; and by week 104 they were 35.5% and 33.5%. Among participants who had already shown a meaningful response by week 12, the reported data shows that 45.6% in the CZP+MTX group and 42.4% in the ADA+MTX group still met the low disease activity threshold at week 104. It is worth noting that a notable number of participants did not complete the full two years — 139 in the CZP+MTX group and 126 in the ADA+MTX group dropped out after week 12. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02093026 · results posted 13 March 2017

    According to the results reported on ClinicalTrials.gov, this trial (NCT02093026) enrolled 465 people with rheumatoid arthritis who received the medication rituximab. The trial was an extension study, meaning participants had already taken part in earlier related trials. Of the 465 who started, 272 completed the study and 193 did not. The trial was measuring how many participants met a standard rheumatoid arthritis scoring threshold — called an ACR20 response — after each repeated course of rituximab. An ACR20 response means a person showed at least a 20% reduction in the number of tender and swollen joints, alongside improvements in at least three out of five other measures of disease activity (such as pain scores and physical function), compared to where they started in the earlier trials. The reported data shows the percentage of participants who met the ACR20 threshold after each of up to six courses of rituximab. After the first course, 67.1% of participants reached this threshold. After the second course, the reported figure was 70.8%, rising to 73.2% after the third course and 75.1% after the fourth course. After the fifth course, the reported percentage was 69.7%, and after the sixth course it was 68.2%. No secondary outcome measure data was included in the submitted results available for this summary. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01988012 · results posted 6 March 2017

    According to the results reported on ClinicalTrials.gov, this trial (NCT01988012) enrolled 100 people who had rheumatoid arthritis — a condition where the immune system attacks the joints, causing pain and swelling. All 100 participants received tocilizumab, a medicine given by injection or infusion. Eighty-five people completed the study, while 15 did not finish. The trial was measuring joint disease activity using several scoring tools that combine things like the number of swollen and tender joints, how the patient felt, how the doctor assessed the patient, and blood test results. The reported data shows the following results for the group receiving tocilizumab. Using a scoring tool called the CDAI (which runs from 0 to 76, where lower is better), the average score at the start was about 31.9, and by the end it had dropped by around 18.3 points. About 16.5% of participants reached "remission" (very low disease activity, score of 2.8 or below), and about 34.1% reached "low disease activity" (score of 10 or below). A similar tool called the SDAI (0 to 86 scale) showed a starting average of roughly 33.7, falling by about 21.4 points; remission was recorded in about 19.2% of participants and low disease activity in about 38.5%. On another commonly used measure called the DAS28-ESR (0 to 10 scale), scores started at around 5.0 and fell by roughly 2.5 points on average. When looking at overall improvement in joint symptoms — measured as at least 20%, 50%, or 70% improvement from the start — the reported data shows that 62.4% of participants met the 20% improvement threshold, 37.6% met the 50% threshold, and 20.0% met the 70% threshold. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01521923 · results posted 10 January 2017

    According to the results reported on ClinicalTrials.gov, this trial involved 357 people with rheumatoid arthritis across four groups. Participants had already taken part in an earlier study period (called Period 1), where they received either a placebo plus methotrexate, or certolizumab pegol (CZP) plus methotrexate. In this second period (Period 1), those who had been on CZP were then either switched to placebo plus methotrexate, continued on a lower-frequency CZP dose (every four weeks), or continued on their original CZP dose (every two weeks). The trial was measuring disease activity scores, joint damage on X-rays, and whether participants could maintain low disease activity over roughly two years without their condition flaring up. The reported data shows that for the main outcome — the percentage of people who kept their disease activity score at a low level (a score of 3.2 or below on a standard 28-joint scale) throughout the second period without flaring — the figures were: 39.2% in the group switched to placebo, 53.2% in the group who continued CZP every four weeks, and 48.8% in the group who continued CZP every two weeks. For a stricter measure of very low disease activity (score below 2.6), the reported percentages were 33.3%, 43.4%, and 44.0% respectively. For joint damage measured by X-ray, the reported data shows no average change from either the original starting point or from the one-year mark across all three groups. The percentage of people showing no meaningful progression of joint damage from the start of the original study through to the end of this period was reported as 69.3%, 77.9%, and 79.2% across the three groups; from the one-year mark onward, those figures were 80.0%, 84.1%, and 90.3%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00996606 · results posted 9 November 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 58 people with active rheumatoid arthritis, all of whom received the study drug tocilizumab. Of those, 50 completed the study and 8 did not. The trial was measuring inflammation (swelling) in the wrist joint using MRI scans, tracked over time — specifically up to 48 weeks. Three different MRI-based methods were used to measure wrist joint inflammation: a scoring system called RAMRIS (scored 0–9, where lower is less inflammation), and two measures of how quickly a contrast dye spreads through the joint tissue (relative enhancement and rate of early enhancement), where lower numbers also indicate less inflammation. The reported data shows that at the start of the trial, participants had an average RAMRIS wrist inflammation score of 5.78 out of 9. By week 4, that average score had changed by −0.88 (meaning it was lower than at the start). The secondary results, which tracked changes at weeks 2, 12, 24 and 48, reported average RAMRIS score changes of −0.44, −1.28, −1.94, and −1.60 respectively. For the contrast-dye measures, the reported data shows the relative enhancement started at an average of 99.25% and changed by −0.48% at week 4, with larger reported changes at later time points (reaching −26.48% at week 24, then −19.74% at week 48). The rate of early enhancement started at 1.19% per second and the reported changes followed a similar downward pattern across all time points measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01162421 · results posted 1 November 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 77 people in total — 37 in a "standard of care" group and 40 in an "early adalimumab" group (adalimumab is a medicine given by injection). The trial was looking at joint damage in people with a form of arthritis, tracking whether their joints got worse over time using X-rays of the hands and feet. Researchers used a scoring system called the modified Total Sharp Score (mTSS), where a higher score means more joint damage; a score change of 0.5 units or less was considered "no progression" (meaning joints had not noticeably worsened). The reported data shows that at the 12-month mark — the trial's main measurement point — about 62.9% of people in the standard care group and 61.5% in the early adalimumab group showed no meaningful progression in their joint damage score. For the secondary measurements, the reported data shows that the average change in the joint damage score from the start of the trial to month 12 was 1.62 units in the standard care group and 0.16 units in the early adalimumab group; by month 24 these figures were 2.24 and 0.01 units respectively. The proportion of participants whose joints worsened rapidly (a score increase of 5 or more units) by month 12 was reported as 14.3% in the standard care group and 2.6% in the early adalimumab group. The trial also tracked how many participants showed meaningful improvements in joint tenderness, swelling, pain, and overall disease activity at multiple time points; these figures varied across the two groups and across the different time points measured, and the full breakdown was reported to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02809833 · results posted 24 October 2016

    According to the results reported on ClinicalTrials.gov, this trial (NCT02809833) enrolled 850 people with rheumatoid arthritis who were receiving tocilizumab as part of their routine medical care. Of those, 550 completed the study and 300 did not. The trial was not testing whether the medicine worked better than another treatment. Instead, it was observing how closely doctors in real-world practice followed official prescribing guidelines around ordering specific blood tests — for liver enzymes (ALAT and ASAT), white blood cell counts (neutrophils), and platelet counts — and whether those test results led to any changes in a patient's dose. The reported data shows that at the start of the study, 98.6% of participants had at least one blood test result on record. However, the picture was more varied when looking at individual tests: liver enzyme results (ALAT) were available for 49.2% of participants, a related liver test (ASAT) for 63.5%, neutrophil counts for 82.9%, and platelet counts for just 7.3%. By weeks 24 and 52, the proportion of participants with any blood test on record dropped to around 87–86%, with similar falls seen across the individual tests. Regarding dose changes, the reported data shows that at weeks 4, 8, and 12, a small percentage of participants had their dose adjusted or interrupted — for example, at week 12, roughly 1.3% of those with mildly elevated liver enzyme results had a dose adjustment recorded, while about 18.3% with those same results did not have any dose change recorded. The data showed very few instances of dose changes related to neutrophil or platelet count results at any time point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00502996 · results posted 14 October 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 232 people, all of whom received rituximab (a medicine given by infusion). Of those, 188 completed the study and 44 did not finish. The trial was primarily measuring the number of participants who experienced unwanted medical events (called adverse events) during treatment, including how serious those events were and whether any were linked to the study medicine. It also looked at some standard blood test results before and after treatment. The reported data shows that 189 out of 232 participants experienced at least one adverse event of any kind during the study, while 12 experienced a serious adverse event (meaning something that was life-threatening, required hospitalisation, or caused significant disability). No deaths were reported. When the adverse events were grouped by how much they affected daily life, 170 participants had mild events (noticed but not disrupting daily life), 102 had moderate events (enough to reduce normal daily activities), 30 had severe events (preventing work or normal activities), and 12 had the most serious category of event. The reported data also shows that 97 participants stopped taking the study medicine due to an adverse event. Two participants experienced a serious adverse event that was considered possibly related to the study medicine, while no participants stopped due to a drug-related adverse event specifically. Regarding infections — which were tracked as events of special interest — 5 participants had an infection recorded at the start of the study (screening), and 12 were recorded at both the end of treatment and end of follow-up. The reported data shows that standard blood measurements taken before and after treatment were broadly similar. For example, average haemoglobin (a measure of red blood cell protein) was 12.4 g/dL at the start and 12.8 g/dL at the end of treatment, and other blood cell counts showed comparably small numerical differences between the two time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00580229 · results posted 4 October 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 50 adults, and all 50 completed the study — none dropped out. The trial was looking at what happened when people were given a steroid tablet called prednisone (40 mg, taken by mouth) about 30 minutes before receiving their first infusion (drip) of a medicine called rituximab. The main thing being tracked was how many people experienced an "acute infusion reaction" — meaning an unwanted physical response during or within 24 hours of that first infusion. The reported data shows that across all 50 participants, there were 50 acute infusion reactions recorded in the first 24 hours following the first rituximab infusion. For the second rituximab infusion, the reported data shows 48 such reactions were recorded within 24 hours. The trial also tracked any other unwanted events that occurred from the day after the second infusion all the way through to week 26 of the study; the reported data shows 48 events were recorded during that longer follow-up period. It is worth noting that the data as reported counts the number of reactions or events, not necessarily the number of individual people who experienced them — these figures are not broken down further in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01649804 · results posted 22 September 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 12 participants, all of whom received the study medicine tocilizumab. The trial was measuring a range of things in people with rheumatoid arthritis, including unwanted medical events that occurred during the study, and changes in how active their arthritis appeared to be using several scoring tools that look at things like tender and swollen joints and blood test results. Of the 12 people who started, 4 completed the study and 8 did not finish. The reported data shows that 75% of participants (that is, 9 out of 12) experienced at least one adverse event — an unwanted or unintended medical occurrence during the study. No participants were reported to have experienced a serious adverse event, and none experienced the specific adverse events of special interest (such as serious infections, heart attack, or cancer). For disease activity measured by one scoring tool (DAS28-ESR), the reported numbers at one time point show 5 participants in remission (very low disease activity), 1 with low disease activity, 4 with moderate activity, and 2 with high activity; at another time point, 10 were in remission, 1 had low activity, 0 had moderate, and 1 had high activity. Using a second scoring tool (SDAI), different numbers of participants fell into each category across two time points. For joint counts, the reported data shows changes in the number of tender and swollen joints across participants, though the specific time points these measurements relate to were not clearly labelled in the submitted data. The data for "time to disease flare" (how long before arthritis worsened again after stopping the medicine) was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01951170 · results posted 21 September 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 52 people, all of whom received the medicine tocilizumab. Fifty-one of the 52 participants completed the study. The trial was looking at several things related to rheumatoid arthritis over 24 weeks, including changes in joint damage visible on imaging, levels of disease activity, and how participants rated their own pain and overall condition. The reported data shows that for the main outcome — a scoring system that measures joint damage (called the modified Total Sharp Score, where a higher number means more damage and a lower number means less) — the average score at the start of the study was 7.00, and the average change from that starting point by week 24 was reported as 0, meaning no average change in that score over the study period. For the secondary outcomes, the reported data shows that around 76.6% of participants met the criteria for a low disease activity category called "remission" on a standard disease activity scale. When looking at a separate measure of improvement called ACR response, approximately 91.5% of participants showed at least a 20% improvement in joint and symptom counts, 76.6% showed at least a 50% improvement, and 53.2% showed at least a 70% improvement. Regarding participants' own ratings on a 0–100 scale, the average starting score for overall disease activity was about 67 out of 100, with an average reported change of minus 48.6 points by week 24. For pain specifically, the average starting score was about 60 out of 100, with an average reported change of minus 41.9 points by week 24. On a separate response measure (EULAR), about 80.9% were classed as "good responders," 17% as "moderate responders," and around 2% as "non-responders." These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01683604 · results posted 21 July 2016

    According to the results reported on ClinicalTrials.gov, this trial (NCT01683604) enrolled 37 adults with rheumatoid arthritis who were starting treatment with a medicine called tocilizumab. Of those 37 participants, 32 completed the study and 5 did not. The participants were divided into subgroups based on whether they had previously tried similar medicines (biologic naïve vs. biologic exposed) and whether they were taking tocilizumab alone or combined with other medicines. The trial was measuring how many people were still on tocilizumab after 6 months, and also recording a range of starting-point (baseline) information about their pain, disease activity, physical function, and joint health. The reported data shows that across all participants, about 84% were still taking tocilizumab at the 6-month mark. When broken down by subgroup, the figure was approximately 79% for those who had not previously tried similar medicines, 100% for those who had, 80% for those on tocilizumab alone, and 84% for those combining it with other medicines. At the start of the trial, participants rated their pain on average at around 58 out of 100 on a scale where 100 means unbearable pain. They rated how well they were managing their disease at around 68 out of 100 (where 100 means managing very poorly), while their doctors rated disease activity at around 65 out of 100. Participants' ability to carry out everyday tasks was scored at an average of 1.7 out of 3 (where 3 means unable to do the task). On average, participants had around 15 tender joints and 32 swollen joints recorded at the start of the study. No follow-up figures for pain, disease activity, function, or joint counts after the 6-month period were included in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00289133 · results posted 15 July 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 461 people in one group (called "GVF Poly") and 477 in another group (called "XLK Poly") — a total of 938 participants — who each received a knee replacement implant. The trial compared two different types of plastic (polyethylene) components used inside the knee implant. Of those who started, 189 in the GVF Poly group and 179 in the XLK Poly group were recorded as having completed the study, with a large number not completing it in both groups. The trial was measuring how long the implants lasted without needing to be removed or replaced (called "revision"), as well as knee condition scores and patient-reported symptoms. The reported data shows that, based on a statistical method called Kaplan-Meier analysis (which estimates the proportion of people whose implant was still in place without needing revision over time), 96.8% of knees in the GVF Poly group and 98.1% of knees in the XLK Poly group had not required revision by the point measured. For a clinician-assessed knee score (rated 0–100, where 100 is the best possible result), the GVF Poly group recorded scores of 94.7 and 93.5 across two reported time points, while the XLK Poly group recorded 93.5 and 93.1. For a patient-reported score measuring pain, stiffness, and physical function (rated 0–96, where a *lower* score indicates a better outcome), the GVF Poly group recorded 10.2 and 11.0 across two time points, and the XLK Poly group recorded 11.5 and 9.8. The reported data also shows that the percentage of knees with notable bone changes visible on X-ray near the femur (thigh bone) component was 9.5% in the GVF Poly group and 7.6% in the XLK Poly group. It is worth noting that the data as submitted does not clearly label which time points correspond to each set of scores, so those figures should be interpreted with that limitation in mind. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01927757 · results posted 11 July 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 90 people who had rheumatoid arthritis and had previously not responded well enough to a medicine called adalimumab. All participants received a different medicine called etanercept. The trial was measuring how many people showed meaningful improvements in their joint symptoms — things like joint tenderness, swelling, pain, and everyday physical function — at 12 and 24 weeks. Of the 90 who started, 88 actually received the study medicine, and 67 completed the trial, with 23 not finishing for various reasons. The reported data shows that the main result — called an "ACR 20 response" — was a way of measuring whether someone's joint symptoms improved by at least 20% across several measures at once. According to the results reported on ClinicalTrials.gov, 35.7% of participants met this level of improvement at week 12, and 34.5% met it at week 24. The trial also looked at higher levels of improvement: about 10.7% of participants reached a 50% improvement level at week 12, rising to 15.5% at week 24; and a 70% improvement level was reached by 2.4% at week 12 and 3.6% at week 24. The reported data also shows a breakdown by subgroup: among those who had developed antibodies against their previous medicine (adalimumab), 50% met the 20% improvement mark at week 12, compared with 32.7% of those who had not developed such antibodies. Among those whose previous medicine had never worked well ("primary failure"), 27.3% reached that mark, compared with 41.2% of those whose previous medicine had worked at first but then stopped working ("secondary failure"). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01578850 · results posted 6 July 2016

    According to the results reported on ClinicalTrials.gov, this trial involved people with rheumatoid arthritis and ran in two stages. In the first stage (Period 1), 489 participants all received open-label etanercept (meaning everyone knew what they were taking) for roughly six months. Those whose disease activity had fallen to a low level by the end of that stage were then eligible for the second stage (Period 2), where 343 participants were randomly split into two groups: 167 continued on etanercept and 176 were switched to a placebo (a dummy treatment with no active ingredient). The trial was measuring how many people in each group maintained "low disease activity" — a score on a standard rheumatoid arthritis rating scale — through to Week 52. The reported data shows that for the main outcome at Week 52, 43.6% of participants in the etanercept group remained in the low disease activity category, compared with 17.3% of participants in the placebo group. A related secondary measure looked at "remission" (an even lower score on the same rating scale): 53.2% of the etanercept group were reported to be in remission at Week 52, versus 29.5% of the placebo group. During the first stage, the proportion of all participants recorded as being in low disease activity climbed over time — starting at around 9.5% at the first check-in and reaching approximately 72.5% by the end of that stage — suggesting the scores were shifting across the group as the stage progressed. During the second stage, similar tracking showed the proportions in low disease activity and remission diverged between the two groups over time, with the etanercept group generally recording higher percentages than the placebo group at the later time points. It is worth noting that these figures describe what was measured and recorded in this specific group of trial participants; the data was not reported in a way that breaks down results for every individual time point across both measures and both periods in full detail. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00503425 · results posted 23 June 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 215 participants, all of whom received the drug rituximab. Of those, 161 completed the study and 54 did not finish. The trial was measuring how participants with what appears to be an inflammatory joint condition responded to rituximab given in up to five separate treatment courses, tracking joint disease activity, bone density, and any unwanted medical events that occurred along the way. The reported data shows that the primary focus was on unwanted medical events (called adverse events). Out of 215 participants, 176 experienced at least one non-serious adverse event, and 70 experienced a serious adverse event — meaning an event that led to hospitalisation, was life-threatening, caused lasting disability, or was otherwise considered significant. For joint disease activity, the trial used a scoring system called DAS28 (a scale of roughly 0–10, where higher numbers mean more active disease). The reported data shows the average starting score was 6.6, which sits in the "high or severe" range. By 24 weeks into each treatment course, the average score dropped by around 2.3 to 2.8 points. The reported data also shows that in each course, roughly 73–87% of participants saw their score improve by more than 1.2 points, which the scale considers a meaningful change. For bone density, the reported data shows small changes from the starting score at the measurement points across courses, though several of those figures were listed as not reported in the data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01236118 · results posted 26 May 2016

    According to the results reported on ClinicalTrials.gov, this trial tested three different doses of a drug called LY2439821 — 30 mg, 80 mg, and 160 mg. A total of 28 people took part across the three dose groups (6, 5, and 17 participants respectively). The main thing the trial was measuring was how many participants experienced adverse events — that is, any unwanted or unexpected health occurrences that happened during the study — including those considered serious. The reported data shows that in the 30 mg group, all 6 participants experienced at least one adverse event of any kind, 3 experienced an adverse event considered to be related to the drug, and 1 experienced a serious adverse event. In the 80 mg group, all 5 participants experienced at least one adverse event of any kind, 4 experienced a drug-related adverse event, and none experienced a serious adverse event. In the 160 mg group, 16 out of 17 participants experienced at least one adverse event of any kind, 7 experienced a drug-related adverse event, and 2 experienced a serious adverse event. The trial also reported how many people completed the study: 4 of 6 in the 30 mg group, 4 of 5 in the 80 mg group, and 14 of 17 in the 160 mg group. No other outcome measures — such as measures of how the drug may have affected any symptoms or condition — were included in the structured results data submitted to ClinicalTrials.gov for this trial, so those figures cannot be reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01664117 · results posted 4 April 2016

    According to the results reported on ClinicalTrials.gov, this trial (NCT01664117) enrolled 209 adults, all of whom were receiving a type of medicine called a biological DMARD (a disease-modifying drug) on its own, without being combined with other medicines of that type. All 209 participants completed the study. Rather than testing a new treatment, this was a single-visit observational study — meaning researchers were collecting a snapshot of background information about the people in the group, such as their education level, smoking history, and details about their rheumatoid arthritis. The reported data shows the following breakdown of participants' characteristics. For education, 1 person reported being unable to read, 15 had no formal education, 86 had primary schooling, 59 had general secondary education, 17 had vocational training, 28 had higher education, and 3 were recorded in a separate category. For smoking status, 170 participants were non-smokers, 15 were current smokers, 23 were ex-smokers, and 1 was recorded separately. Among those who had ever smoked, the reported data shows an average smoking history of around 120–122 pack-years (a measure combining how much and how long someone smoked), with an average of about 19 years of smoking and roughly 9 years since quitting for ex-smokers. The reported data also shows that, on average, participants had been living with rheumatoid arthritis for about 13.5 years. Regarding family history, 15 participants reported a family history of rheumatoid arthritis, 160 did not, and 34 were recorded separately (possibly unknown or not answered). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01326962 · results posted 28 March 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 28 people, all of whom received a medication called tocilizumab (there was no comparison group). Twenty-one participants completed the study, and seven did not finish. The trial was measuring disease activity in people with rheumatoid arthritis (a condition causing joint inflammation and pain) using a scoring tool called the DAS28. This tool gives a score from 0 to 10, where higher numbers mean more active disease. The trial tracked scores over multiple points in time, and also looked at how many participants reached "remission" (a score below 2.6, meaning very low disease activity), how many showed a meaningful improvement in their score, and how many reported improvements in everyday physical tasks like dressing, walking, and eating. The reported data shows that the average DAS28 score across the group started at 5.4 at the beginning of the study and was recorded as low as 1.7 at certain later time points, before sitting at 2.1 at the final measurement. In terms of remission (score below 2.6), the number of participants reaching that threshold at each time point ranged from 3 (early in the study) up to a peak of 18, before coming back down to 4 at the last recorded time point. The reported data also shows that the average time from the first treatment to first reaching remission was approximately 189 days. Regarding meaningful improvement in the DAS28 score (a drop of at least 1.2 points), the numbers ranged from around 11 to 22 participants across the various time points, with 4 participants recorded at the final time point. For the everyday physical tasks questionnaire (HAQ), the number of participants showing a meaningful improvement at each time point ranged from 2 to 7; data for the final time point was not reported for this measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01672970 · results posted 28 March 2016

    According to the results reported on ClinicalTrials.gov, this trial (NCT01672970) enrolled 291 people with rheumatoid arthritis (RA), of whom 290 received the study treatment — a medicine called tocilizumab (TCZ). By the end of the study, 244 participants had completed it, while 47 did not finish for various reasons. The trial was looking at how many people were still taking tocilizumab six months after starting it, as well as gathering background information about participants' prior treatments and disease characteristics. The reported data shows that 81% of participants were still on tocilizumab at the six-month mark. Regarding participants' health at the time they joined the study, 13.8% were reported to have broader, body-wide features of RA beyond joint symptoms — such as anaemia, fatigue, or lung involvement. When it came to other RA medicines (called DMARDs — disease-modifying antirheumatic drugs), 60.7% of participants had stopped taking them before the study began. A further 12.1% stopped their DMARDs at the point of joining the study. The reported reasons for stopping DMARDs at that point included factors such as lack of effect (22.1%), side effects (7.2%), and other reasons (19.3%). The trial also collected information on how many previous biological RA treatments participants had received, and the reported data shows that all of those prior biological treatments had lasted longer than six months (100%), with none lasting under six months (0%). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01346501 · results posted 11 March 2016

    According to the results reported on ClinicalTrials.gov, this trial involved 172 people with rheumatoid arthritis — 79 in a group that continued or restarted the medicine adalimumab, and 93 in a group that had stopped taking it. The trial was measuring several things: whether people who had stopped adalimumab could maintain low disease activity (using a scoring system called DAS28-CRP, which rates joint inflammation and overall disease activity on a scale of 0 to 9, where lower is better); changes in a blood marker linked to joint damage (MMP-3); participants' self-reported ability to carry out everyday physical tasks (HAQ score, from 0 to 3); and X-ray measures of joint damage over time. The reported data shows that, among those who had stopped adalimumab, 100% started with a low disease activity score, but this proportion gradually fell over time — dropping to around 46% by the final measurement point, meaning that over time fewer people in that group maintained their low disease activity score without a flare-up. For the MMP-3 blood marker (where higher than normal levels may indicate joint damage activity), the reported data shows the percentage of participants with above-normal levels fell in both groups across the study period, though figures varied at different time points. For everyday physical function (HAQ), both groups started with similar scores and both showed lower (improved) scores over time, with the reported figures remaining broadly similar between the two groups throughout. On the X-ray joint damage measure, the reported data shows that at the end of the observation period, 66% of the adalimumab group and 56% of the non-adalimumab group had minimal change in joint damage scores (≤0.5), while 83% and 67% respectively fell within the slightly broader threshold of ≤1.5. The reported data also shows that adverse drug reactions (unexpected medical events that could not be ruled out as being related to adalimumab) were recorded in 16% of participants in the adalimumab group and 2% in the non-adalimumab group, with serious adverse drug reactions reported in 2% of the adalimumab group and 0% of the non-adalimumab group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01117480 · results posted 24 February 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 1,013 people diagnosed with moderate-to-severe rheumatoid arthritis. Of those, 985 completed the study and 28 did not. The trial was measuring disease activity in rheumatoid arthritis across several time points, looking at joint swelling and tenderness, physical function in daily tasks, and participants' own ratings of how their condition felt. The reported data shows that the main (primary) outcome tracked the percentage of participants whose disease activity score (called DAS28 — a combined measure of joint counts, a blood marker, and the participant's own rating) fell below 2.6, which is the threshold considered to represent remission (very low disease activity). According to the results reported on ClinicalTrials.gov, the percentages of participants reaching that threshold at successive time points were 11%, 13%, 16%, 15%, and 16%. For physical function — measured using a questionnaire called the HAQ, scored from 0 (no difficulty) to 3 (severe difficulty) — the starting average score was 1.39, and the reported changes from that starting point at later time points were −0.31, −0.34, −0.37, and −0.37 (negative numbers meaning the score moved lower). For participants' own rating of disease activity (called RADAI, scored 0–10), the starting average was 5.4, and the reported changes were −1.55, −1.77, −1.88, and −1.93 at successive time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01071798 · results posted 22 February 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 1,653 people with rheumatoid arthritis who received at least one treatment cycle, and 820 of those went on to receive a second cycle. The trial was measuring two main things over time: a disease activity score called the DAS28 (which combines information about swollen and tender joints, a blood marker of inflammation, and how the patient rated their own condition on a scale of 0–10, where higher numbers mean more disease activity) and a disability score called the HAQ-DI (which measures how much difficulty a person has with everyday tasks like dressing, eating, and walking, on a scale of 0–3, where 0 means no difficulty). The reported data shows that, across all participants, the average DAS28 score started at 5.3 and moved to 4.8, then 4.4, and finally 4.0 by the last recorded time point. Similar patterns were seen in subgroups defined by certain blood test results (seropositive and seronegative participants). For the HAQ-DI, the reported average score across all participants started at 1.5 and moved to 1.4, then 1.3, and finally 1.2 by the last time point. The reported data also shows that for participants who had only one treatment cycle, the largest single group — 185 out of a subgroup — showed no clinically meaningful change in their HAQ score, while 146 showed an improvement of 0.3 points or more and 44 showed a worsening of 0.3 points or more. Similar breakdowns were reported for those who completed two cycles. Regarding adverse events (unwanted health events that occurred during treatment), the reported data shows that 28.5% of all participants experienced at least one such event during the first cycle, and 21.1% did so during the second cycle. More specific categories of adverse events were also tracked, with figures ranging from around 1.3% to 10.9% depending on the type and cycle. Some sub-figures for the HAQ disability data were listed as not available in the reported results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01245439 · results posted 3 November 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled 65 participants, all of whom received the study drug tocilizumab at a dose of 8 milligrams per kilogram of body weight. All 65 participants completed the study with none dropping out. The trial was primarily focused on tracking unwanted medical events (called adverse events) that occurred during or after receiving the study drug, including serious events, infections, and reactions during the infusion (when the drug is given through a drip). It also looked at certain liver-related blood test results as secondary measures. The reported data shows that 90.8% of participants experienced at least one adverse event (an unwanted medical occurrence) during the study, 9.2% experienced a serious adverse event, and 52.3% experienced an infection of any kind. Regarding serious infections specifically, the reported figures show that 1.5% of participants (1 person) had a serious infection at each of three separate time points measured. No participants stopped treatment early for any reason — the discontinuation rate was reported as 0%. For the liver enzyme blood tests (ALT and AST, which can indicate stress on the liver), the reported data shows that most participants had no notable elevations beyond 3 times the upper limit of the normal range, with only small numbers recording mild elevations above 1.5 times the normal range across different time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01866150 · results posted 5 October 2015

    According to the results reported on ClinicalTrials.gov, this trial (NCT01866150) enrolled 450 participants, all of whom completed the study. It followed people with rheumatoid arthritis who were starting their first biologic (a type of specialised medicine) treatment, comparing two groups: those taking a biologic medicine on its own ("monotherapy") and those taking a biologic medicine together with another medicine ("combination therapy"). The trial measured disease activity using a scoring system called DAS28, which uses information about tender and swollen joints, a patient's own rating of their condition, and a blood test result. A score below 2.6 is defined in the trial as "remission" (very low disease activity), and a score below 3.2 as "low disease activity." The reported data shows that at the six-month mark — the main measurement point — about 30.7% of participants in the monotherapy group and 31.9% in the combination therapy group reached the remission score threshold. For the additional measurements, at three months roughly 23.9% (monotherapy) and 27.6% (combination) reached remission, rising to 44.4% and 46.9% respectively at participants' last recorded visit. When looking at "low disease activity" (the slightly less strict cut-off), the reported figures at six months were 50.0% (monotherapy) and 53.4% (combination), and at the last visit 57.1% and 67.1%. The reported data also shows that average DAS28 scores fell from baseline by approximately 3.0 points (monotherapy) and 3.18 points (combination) at six months. Participants in the monotherapy group stayed on their treatment for a reported average of about 57 months, compared with about 48 months in the combination group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01640548 · results posted 2 October 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled 309 adults with rheumatoid arthritis (RA), and all 309 completed the study with no dropouts recorded. The trial was an observational study — meaning it watched and recorded what was already happening rather than testing a new treatment — focused on understanding how people with RA were being treated with a type of medicine called biologic disease-modifying anti-rheumatic drugs (bDMARDs, a group of medicines that target specific parts of the immune system). In particular, it looked at how many participants were taking these medicines on their own (called "monotherapy," meaning without combining them with other RA medicines), and what treatments they had received before. The reported data shows that among the 309 participants currently on biologic monotherapy, the most commonly used medicine was etanercept (about 39.5% of participants), followed by adalimumab (about 28.8%), tocilizumab (about 12.3%), and rituximab (about 10.7%), with smaller proportions on other medicines. Looking back at what traditional (non-biologic) medicines participants had taken previously, the reported data shows that around 94.7% had previously taken methotrexate, 78.9% sulfasalazine, and 46.9% leflunomide, among others. Nearly all participants (96.1%) were also recorded as taking additional non-DMARD treatments such as corticosteroids or anti-inflammatory pain medicines alongside their main RA treatment. A secondary measure — a standard scoring tool used to gauge how active a person's RA is, rated on a scale from 0 to 9.4 — recorded average scores of 3.41 and 3.21 (measured using two slightly different methods), where higher numbers indicate more active disease. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00688103 · results posted 1 October 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled 151 people with rheumatoid arthritis — 74 in a group receiving etanercept (ETN) alone, and 77 in a group receiving etanercept combined with methotrexate (ETN+MTX). The trial was measuring three things: a disease activity score called EULAR Good Response, a joint improvement measure called ACR50, and changes in joint damage visible on X-rays over time. Not everyone who started the trial finished it — 44 out of 74 people completed it in the ETN alone group, compared to 64 out of 77 in the combination group. The reported data shows the following results at the end of the trial. For the EULAR Good Response measure (which looks at how much disease activity improved), 33.3% of people in the ETN alone group met the target, compared to 52.1% in the combination group. For the ACR50 measure (which looks at at least a 50% improvement across several joint and symptom counts), 47.8% of the ETN alone group met that target, compared to 64.4% in the combination group. For X-ray joint damage, the reported data shows an average change in score of 3.6 points in the ETN alone group and 0.8 points in the combination group, on a scale that runs from 0 to 448 (where a higher number reflects more joint damage). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01519791 · results posted 22 September 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled 879 people in total — 219 in the placebo plus methotrexate group and 660 in the certolizumab pegol plus methotrexate group. The trial was measuring whether adding certolizumab pegol to methotrexate (a common medicine for inflammatory joint conditions) made a difference compared to adding a placebo (an inactive dummy treatment) to methotrexate. The main thing the trial was looking at was how many participants reached a sustained state of low disease activity — specifically, scoring below a certain threshold on a joint disease activity scale at both Week 40 and Week 52 of the study. The reported data shows that for the primary goal — the percentage of people who reached sustained remission (that is, a low disease activity score at both Weeks 40 and 52) — 15.0% of people in the placebo plus methotrexate group met this measure, compared with 28.9% in the certolizumab pegol plus methotrexate group. For a related secondary measure looking at a slightly broader category called "sustained low disease activity," the reported figures were 28.6% for the placebo group and 43.8% for the certolizumab pegol group. The trial also looked at joint damage using X-ray scoring. The reported data shows the average change in overall joint damage score from the start to Week 52 was 1.8 points in the placebo group and 0.2 points in the certolizumab pegol group (on a scale where higher numbers mean more damage). Additionally, 49.7% of the placebo group showed no meaningful progression of joint damage on X-ray, compared with 70.3% in the certolizumab pegol group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01468077 · results posted 17 August 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled 47 people in total — 22 in a group receiving tocilizumab (a medication used for rheumatoid arthritis) through a standard-speed intravenous drip, and 25 in a group receiving the same medication through a faster drip. Of those, 18 and 22 participants respectively completed the study. The trial was measuring whether the speed of the drip made a difference to reactions during or shortly after the infusion, as well as tracking things like changes in liver enzyme levels, cholesterol levels, and disease activity scores over time. The reported data shows that 13.6% of participants in the normal-speed group and 12.0% in the faster-speed group experienced a reaction during or within 24 hours of their infusion. Around 9% of the normal-speed group and 8% of the faster-speed group stopped the medication due to an unwanted event, while 9% and 4% respectively stopped for other reasons. For liver enzymes, some participants showed mildly elevated readings (above 1.5 times the normal upper limit) at various points during the study, but the reported data shows no participants in either group reached the higher thresholds of 3 or 5 times the upper limit. For cholesterol, the reported figures varied across visits but roughly 36–55% of participants in both groups had elevated lipid readings at different time points. Regarding disease activity scores, the reported data shows that by the later visits, around 89–94% of the normal-speed group and 77–86% of the faster-speed group had a meaningful reduction in their disease activity score of at least 1.2 points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00565409 · results posted 10 August 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled 834 people with rheumatoid arthritis. The trial had two stages. In the first stage, all 834 participants received a combination of two medicines — etanercept (50 mg) and methotrexate — for 36 weeks, with no comparison group. Of those 834, 756 completed this first stage, and 604 went on to enter the second stage. In the second stage, 604 participants were randomly assigned to one of three groups: continuing on the higher dose of etanercept (50 mg) plus methotrexate, switching to a lower dose of etanercept (25 mg) plus methotrexate, or switching to a dummy (placebo) treatment plus methotrexate — without knowing which group they were in. The trial was primarily measuring what proportion of participants in each group had low disease activity (based on a scoring tool called the DAS28, which combines joint counts and other measures into a number from 0 to 10) by week 88. The reported data shows that, at week 88, around 82.6% of participants in the higher-dose etanercept group, 79.1% in the lower-dose etanercept group, and 42.6% in the placebo group had a DAS28 score indicating low disease activity. For the secondary measures, the reported data shows that during the first stage, the proportion of all participants reaching low disease activity grew steadily over time — from under 1% at the start to around 82% by week 36. In the second stage, the reported data shows that the proportion of participants maintaining low disease activity declined more noticeably in the placebo group over time compared with the two etanercept groups. For the time-to-worsening measure, the reported data shows that the median number of days until participants in the placebo group lost low disease activity was 85 days; for the two etanercept groups, a median figure was not reached, meaning the data was not reported in a way that produced a definitive number for those groups within the study period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00928512 · results posted 30 July 2015

    According to the results reported on ClinicalTrials.gov, this trial (NCT00928512) enrolled 237 adults with rheumatoid arthritis across five groups. Participants received one of four doses of a medicine called secukinumab (300 mg, 150 mg, 75 mg, or 25 mg) or a placebo (a dummy treatment with no active ingredient). The trial was mainly measuring how many people in each group reached a standard rheumatology benchmark called ACR20 by week 16 — a score that requires at least a 20% improvement in joint tenderness, joint swelling, and at least three other disease measures such as pain ratings and a blood marker of inflammation. The reported data shows that at week 16, the number of participants who met the ACR20 threshold was 22 out of 41 in the 300 mg group, 20 out of 43 in the 150 mg group, 23 out of 49 in the 75 mg group, 18 out of 54 in the 25 mg group, and 18 out of 50 in the placebo group. For the higher response thresholds (ACR50, meaning at least 50% improvement), the numbers were 7, 9, 9, 8, and 3 participants respectively; for ACR70 (at least 70% improvement), the numbers were 2, 2, 1, 4, and 0 respectively. All groups also showed a decrease in a disease activity score (DAS28-CRP, where lower is less active disease), ranging from −0.96 in the placebo group to −1.46 in the 75 mg group. Changes in quality-of-life and fatigue scores were also measured and reported as modest increases across all groups, including placebo, though the specific figures varied by group and are detailed in the full trial record. The reported data also shows that a number of participants did not complete the study — for example, 10 people in the 300 mg group and 21 in the 25 mg group did not finish. These numbers are part of the full picture of what was observed during the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01782469 · results posted 30 July 2015

    According to the results reported on ClinicalTrials.gov, this trial (NCT01782469) enrolled 16 adults with rheumatoid arthritis, and 15 of them completed the study. The trial was looking at the drug adalimumab over 13 weeks, with the main focus on measuring joint inflammation (called synovitis) using ultrasound scans. Twelve joints were assessed — including elbows, wrists, knuckles, knees, and ankles on both sides of the body — and each joint was given an inflammation score from 0 (none) to 3 (major), giving a total possible score of 0 to 36. The reported data shows that the average total inflammation score across participants dropped by 9.6 points after 13 weeks of treatment. For the secondary measures, the reported data shows a percentage reduction in the inflammation score at different time points during the study of approximately 21%, 36%, 48%, and 57% — suggesting the scores were changing over the course of the study, though these figures are as reported and no comparison group was included. The average number of joints showing signs of erosion (wearing away of the joint) was reported to decrease over time, from around 9.4 joints at the start to approximately 6.1 joints by the end. Nearly 94% of participants were reported to have achieved at least a 20% improvement in both the number of tender joints and swollen joints. A questionnaire measuring participants' ability to carry out everyday tasks (scored 0–3, where lower is better) was also used, but the reported data notes that due to an error, the 13-week result was not collected; only a baseline score of 1.19 was reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00626275 · results posted 1 July 2015

    According to the results reported on ClinicalTrials.gov, this trial (NCT00626275) tested a study drug called ADL5859 in people with lower limb pain, comparing it to a common pain reliever called naproxen and to a placebo (a dummy treatment with no active ingredient). The trial had two parts. In Part A, 46 people took part and each person received all three treatments one after another in a different order, with rest periods in between. In Part B, a separate group of 44 people were split into two groups — 20 received ADL5859 and 24 received placebo — and took their assigned treatment for two weeks. The reported data shows that in Part A, the main thing being measured was the change in lower limb pain scores after participants walked on a treadmill. Pain was rated on a scale of 0 (no pain) to 10 (worst possible pain). According to the results reported on ClinicalTrials.gov, the average reduction in treadmill-evoked pain over six hours was 1.12 points for placebo, 1.95 points for naproxen, and 1.20 points for ADL5859. For overall pain intensity at six hours after dosing, the reported reductions were 1.40 points for placebo, 2.09 points for naproxen, and 0.86 points for ADL5859. In Part B, participants rated their leg pain three times a day over two weeks. The reported average daily pain scores were approximately 4.28 (placebo, week 1) and 4.17 (ADL5859, week 1), and 4.23 (placebo, week 2) and 4.13 (ADL5859, week 2) — all on the same 0–10 scale. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01844895 · results posted 1 July 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled 120 participants who all received a 125 mg dose of abatacept (a medicine used in conditions like rheumatoid arthritis) by self-injection under the skin. For the first four weeks (up to Day 29), participants used a prefilled syringe, then switched to an autoinjector device for the remaining three months (up to Day 113). The trial was primarily measuring how much of the medicine was present in participants' blood at its lowest point between doses — known as the "trough concentration" — to compare the two delivery devices. Of the 120 who started, 117 completed the first phase and 111 completed the second phase. The reported data shows that the average lowest blood level of abatacept at steady state (when levels had stabilised) was 27.76 micrograms per millilitre (µg/mL) with the prefilled syringe and 25.32 µg/mL with the autoinjector. For the secondary measurements, the reported peak blood concentration was 40.9 µg/mL with the prefilled syringe and 39.8 µg/mL with the autoinjector. The median time to reach that peak was reported as 70 hours for the prefilled syringe and approximately 56 hours for the autoinjector. The total amount of medicine in the blood over a dosing week was reported as 5,740 µg·h/mL (prefilled syringe) and 5,643 µg·h/mL (autoinjector). Regarding the body's immune response to the medicine itself, the reported data shows that 1 participant tested positive on Day 29 and 1 on Day 113 for one type of antibody response, and 5 participants on Day 29 and 2 on Day 113 for another type — though what this means clinically was not described in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00754572 · results posted 15 May 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled 418 people, all of whom received a treatment called tocilizumab. There was no comparison group. Of the 418 who started, 347 completed the study and 71 did not. The trial was measuring how participants' rheumatoid arthritis responded over 24 weeks, using a standard scoring system that looks at things like swollen and tender joints, pain, and general wellbeing, as rated by both the participant and their doctor. The reported data shows that the main thing being measured — called an "ACR50 response" — was whether participants showed at least a 50% improvement across several joint and wellbeing measures by week 24. According to the results, 73.23% of participants reached that level of improvement. For a lower improvement threshold (20% improvement, called ACR20), the reported figure was 90.55% of participants. For a higher threshold (70% improvement, called ACR70), it was 50.39%. The reported data also shows that, on average, the number of swollen joints went from about 25 at the start of the study down to about 4.6 at week 24, and the number of tender joints went from about 16 down to about 2.6 — representing reported reductions of around 81% and 85% respectively. Some other planned measurements, including time to response and changes in haemoglobin, were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00422383 · results posted 4 May 2015

    According to the results reported on ClinicalTrials.gov, this trial looked at different doses of a medicine called rituximab, always given together with another medicine called methotrexate, in people with rheumatoid arthritis. There were five groups in the trial: a low dose group (134 participants), an escalated dose group (120 participants), a high dose group (93 participants), a placebo/rituximab group (6 participants), and a decreased dose group (25 participants). The trial measured how participants' joint symptoms and overall disease activity changed over approximately 48 weeks (about one year). The reported data shows that for the main outcome — the percentage of participants who showed at least a 20% improvement in a standard joint assessment score (known as ACR20) — the figures were 64.2% in the low dose group, 63.9% in the escalated dose group, and 72.0% in the high dose group. For a higher bar of 50% improvement (ACR50), the reported figures were 39%, 39%, and 48% respectively, and for a 70% improvement bar (ACR70), they were 20%, 19%, and 23%. A separate disease activity score (rated on a scale where higher numbers mean more active disease) was also reported to have decreased from the starting point by around 2.1 to 2.4 points across the three main groups. For a fatigue questionnaire scored from 0 to 52, the reported changes from the starting point ranged from approximately 2.0 to 8.4 points across all five groups, where a positive number indicates a change in the direction of less fatigue. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00578305 · results posted 10 April 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled 185 people with rheumatoid arthritis across three groups: 62 received a lower dose of rituximab (500 mg), 60 received a higher dose (1,000 mg), and 63 received a placebo (an inactive treatment). The trial used MRI scans to measure changes in the bones and joints of the hand and wrist over time — specifically looking at bone erosion (damage to bone), synovitis (inflammation in the joint lining), and osteitis (inflammation within the bone itself). Scores on these MRI measures were tracked at 12, 24, and 52 weeks, with a lower or more negative score meaning less damage or inflammation compared to the start of the trial. The reported data shows that for the primary outcome — change in bone erosion score at 24 weeks — the rituximab 500 mg group had an average score change of +0.13, the rituximab 1,000 mg group +0.39, and the placebo group +1.33 (on a 0–100 scale, where a higher number means more erosion). At 52 weeks, the reported data shows the rituximab 500 mg group had a change of +0.11, the 1,000 mg group –0.30, and the placebo group +3.02. For the joint inflammation (synovitis) score at 52 weeks, the reported changes were –2.03 (500 mg group), –2.73 (1,000 mg group), and –0.01 (placebo group), where a negative number means the score went down from the start. For bone inflammation (osteitis) at 52 weeks, the reported changes were –4.75, –3.83, and –0.22 respectively. Regarding the proportion of participants who showed no worsening in bone erosion at week 24 (using a broad definition that includes no meaningful increase), the reported data shows 88.7% in the 500 mg group, 96.7% in the 1,000 mg group, and 81.0% in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00669942 · results posted 30 March 2015

    According to the results reported on ClinicalTrials.gov, this trial (NCT00669942) tested a drug called AIN457A (also known as secukinumab) in people with rheumatoid arthritis, as well as in a small number of healthy volunteers. The trial ran in multiple parts. In Part 1, 32 rheumatoid arthritis patients were divided into four dose groups (0.3, 1.0, 3.0, or 10 mg/kg) or a placebo group, and the main goal was to understand how the drug moved through the body. In Parts 2 and 3, a further 64 rheumatoid arthritis patients received either the 1.0, 3.0, or 10 mg/kg dose or a placebo, and the main goal was to measure how many participants showed a meaningful improvement in their joint disease based on a standard set of criteria called ACR20 — which requires at least a 20% improvement in tender joints, swollen joints, and several other measures of disease activity. Eight healthy volunteers also took part in a separate arm of Part 1. The reported data shows that for the key clinical question in Parts 2 and 3, 46% of participants who received the 10 mg/kg dose met the ACR20 response standard, compared with 27% of those who received the placebo. For the body-chemistry measurements in Part 1, the drug was detected at its highest level in the blood very quickly after the infusion — roughly two hours after dosing across all dose groups. The reported peak blood levels ranged from about 8.8 micrograms per millilitre in the lowest dose group up to about 212 micrograms per millilitre in the highest dose group, rising in line with the dose given. The total amount of drug the body was exposed to over time, and the speed at which the body cleared the drug, followed a similar pattern across all four dose groups tested. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00556894 · results posted 9 March 2015

    According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called CF101 (tested at two different doses — 0.1 mg and 1 mg) compared to a placebo (a dummy treatment with no active ingredient) in people with rheumatoid arthritis. A total of 253 people were enrolled across the three groups: 82 in the CF101 0.1 mg group, 87 in the CF101 1 mg group, and 84 in the placebo group. Not everyone finished the trial — 66, 68, and 65 people respectively completed it. The main thing being measured was whether participants' symptoms improved by at least 20% after 12 weeks, using a standard checklist called the ACR20 criteria. The reported data shows that at the 12-week mark, 29 out of 82 people in the CF101 0.1 mg group, 34 out of 87 in the CF101 1 mg group, and 33 out of 84 in the placebo group met the ACR20 threshold — meaning their symptoms had reduced by at least 20% according to that checklist. These are the raw counts as submitted; no further breakdown between the groups was provided in the data beyond these numbers. For the secondary outcomes — which looked at higher levels of improvement (50% and 70%), changes in a disease activity score called DAS28, and other related measures over time — the reported data shows that specific numbers were not included in the submitted results on ClinicalTrials.gov, so those figures cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01359943 · results posted 2 March 2015

    According to the results reported on ClinicalTrials.gov, this trial (NCT01359943) enrolled 221 adults with rheumatoid arthritis across three groups: 88 people received secukinumab by intravenous (drip) infusion at a 10 mg/kg dose, 89 received secukinumab as a 150 mg injection under the skin, and 44 received a placebo (a dummy treatment with no active ingredient). The trial ran for up to 60 weeks in total, with the first 16 weeks being a blinded phase — meaning neither participants nor their doctors knew which treatment they were receiving. The main thing the trial was measuring was whether participants reached a standard rheumatology benchmark called ACR20, which means at least a 20% improvement in joint tenderness, joint swelling, and several other measures of disease activity. The reported data shows that, at 16 weeks, 53.4% of participants in the intravenous secukinumab group, 44.9% in the under-skin injection group, and 40.9% in the placebo group met the ACR20 threshold. For more demanding improvement thresholds (ACR50, meaning at least 50% improvement), the figures reported were 20.5%, 18.0%, and 11.4% respectively; for ACR70 (at least 70% improvement), the reported figures were 8.0%, 5.6%, and 0.0%. The reported data also shows changes in a disability questionnaire score (HAQ-DI, rated 0–3, where lower is better): the intravenous group showed an average change of −0.35, the injection group −0.28, and the placebo group −0.17. Two separate composite disease-activity scores (DAS28-CRP and DAS28-ESR, both rated 0–10, where lower scores indicate less active disease) also showed reductions across all three groups, with the secukinumab groups showing slightly larger decreases than the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01254331 · results posted 26 February 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled 51 participants, all of whom received the medicine tocilizumab. There was no comparison (control) group. The trial ran in two back-to-back phases — an initial phase and an extension phase. By the end of both phases combined, 41 participants had completed the full study. The trial was measuring how joint disease activity changed over time in people taking tocilizumab, using several scoring tools that look at things like the number of swollen and tender joints, and how active the disease appeared overall. The reported data shows a range of figures across multiple time points. Using a joint-disease scoring system called DAS28 (which combines swollen and tender joint counts with a blood test result and the participant's own rating of their condition), the proportion of participants recorded as having a clinically meaningful improvement — defined as a drop of at least 1.2 points on that scale — ranged from about 57% at an early time point up to around 93% at a later one. The proportion recorded as having "low disease activity" on the same scale rose from around 10% early on to around 66% at one later point. The proportion recorded as being in "remission" on that scale started at 0% and reached up to around 45% at later time points. Separately, using a different measurement system (ACR scores), the reported data shows that the share of participants meeting the threshold for at least a 20% improvement in joint counts and other assessments ranged from roughly 29% to 61% across different time points, while fewer participants met the higher thresholds of 50% or 70% improvement. The average number of swollen and tender joints also appeared to change across the course of the study, though the specific figures for each time point varied. The median time to reach the 20% improvement threshold was reported as 8 weeks, and the median time to reach the 50% threshold was reported as 20 weeks; a median time for the 70% threshold was not reported in the data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01034397 · results posted 6 February 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled 54 people in total — 35 received tocilizumab (a medicine given by infusion, at a dose of 8 milligrams per kilogram of body weight) and 19 received a placebo (an inactive dummy treatment). By the end of the study, 28 people in the tocilizumab group and 17 in the placebo group had completed it. The trial was measuring changes in joint inflammation (called synovitis) and joint damage using a special MRI scanning method, with scores tracked at 12 weeks and 24 weeks. Some participants who started on placebo were later switched to tocilizumab, so results at 24 weeks include three groups. The reported data shows that the main thing being measured — the percentage change in synovitis score at 12 weeks — showed a reported reduction of around 20–25% in the tocilizumab group and a reduction of 0–37.5% in the placebo group, depending on which part of the hand was measured (the wrist area or the finger joints). For the overall combined MRI damage score (which adds together measures of swelling, fluid in the bone, and bone erosion) at 12 weeks, the reported data shows a reduction of about 10.6% for tocilizumab and 15.4% for placebo. At 24 weeks, the reported figures show a reduction of about 24.2% for those who stayed on tocilizumab, 17.3% for those who stayed on placebo, and 36.8% for those who switched from placebo to tocilizumab partway through. In terms of actual score points (not percentages), the combined damage score fell by 5.5 points (tocilizumab) versus 7.0 points (placebo) at 12 weeks, and by 13.0 points (tocilizumab) versus 3.0 points (placebo) versus 14.0 points (placebo-to-tocilizumab switchers) at 24 weeks. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01142726 · results posted 17 October 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 351 people with rheumatoid arthritis across three groups: one group received abatacept combined with methotrexate (119 people), one received abatacept alone with a dummy (placebo) version of methotrexate (116 people), and one received methotrexate alone with a placebo version of abatacept (116 people). The trial was measuring how many participants reached "remission" — meaning their joint disease activity score dropped below a certain threshold — using a scoring system called the DAS28-CRP, which takes into account tender and swollen joints, a blood marker of inflammation, and the patient's own rating of their health. The reported data shows that for the main (primary) outcome — reaching remission at month 12 — about 60.9% of people in the abatacept-plus-methotrexate group met that threshold, compared with 45.2% in the methotrexate-alone group. When a stricter measure was applied — remission at both month 12 and month 18 — the reported figures were 14.8% and 7.8% respectively. For the abatacept-alone group, the reported remission rate at month 12 was 42.5%, dropping to 12.4% when both time points were required. A separate scoring tool called the SDAI also showed remission rates at month 12 of 42.0% (combination group), 29.3% (abatacept alone), and 25.0% (methotrexate alone). Disease activity scores across all three groups decreased from their starting points over the course of the trial, with the reported reductions being largest in the combination group at most time points measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00720798 · results posted 30 September 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 2,067 adults who received the medication tocilizumab, which is used in the treatment of rheumatoid arthritis. The study ran for roughly eight years and was a long-term follow-on study. Of those who started, 1,311 completed the study and 756 did not. The trial was tracking a range of things, including unwanted events (called adverse events), how many people stopped treatment, and how participants' joint symptoms changed over time using a standard scoring system called the ACR score — a way of measuring improvement in tender and swollen joints alongside other symptoms like pain and physical function. The reported data shows that 96.3% of participants experienced at least one adverse event during the study. Around 36.6% of participants withdrew from treatment at some point. Roughly half of all participants were taking oral corticosteroids (a type of anti-inflammatory tablet) alongside tocilizumab throughout the study, with that proportion gradually declining from about 55.8% in the first six-month period to around 48.4% by the final period. Only 1.2% to 15.6% of participants (varying by time period) switched from taking tocilizumab alone to combining it with another arthritis medicine. Looking at ACR score improvements, the reported data shows that at week 24 approximately 59.5% of participants had at least a 20% improvement, rising to around 78.7% by week 264; for a 50% improvement, the figures ranged from about 34.9% at week 24 to 58.8% at week 264. The proportion achieving what was called a "major clinical response" — meaning a sustained, substantial improvement held for at least 24 weeks — rose from 8.5% at week 48 to 24.9% by week 264. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02010216 · results posted 25 September 2014

    According to the results reported on ClinicalTrials.gov, this trial (NCT02010216) involved 23 participants who all received the medication tocilizumab (also known as RoActemra or Actemra). All 23 participants completed the study — none dropped out. The trial was measuring changes in rheumatoid arthritis disease activity, using a scoring tool called the DAS28 (a scale from 0 to about 10, where lower scores mean better disease control), as well as a set of response criteria called ACR20/50/70 (which describe whether a participant's joint symptoms improved by at least 20%, 50%, or 70% compared to the start of the trial). The trial also recorded the number of participants who experienced any unwanted health events during the study. The reported data shows that, on average, participants' DAS28 scores fell by 3.9 points from where they started (a negative change on this scale means scores moved in the direction of better disease control). For the ACR response measures — assessed after the third infusion — the reported data shows that none of the participants (0%) reached only the lowest response level (ACR20), approximately 9.5% reached the middle level (ACR50), and approximately 66.7% reached the highest level measured (ACR70). Regarding unwanted health events, the reported data shows that 5 out of 23 participants experienced an adverse event (an unexpected or unwanted sign, symptom, or health issue during the study), and 0 participants experienced a serious adverse event (a more severe health event such as hospitalisation or life-threatening illness). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00750880 · results posted 7 August 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 1,681 adults who all received tocilizumab (TCZ) at a dose of 8 milligrams per kilogram of body weight. There was no comparison group — every participant received the same treatment. The trial was measuring how rheumatoid arthritis disease activity changed over time using several scoring systems, including the DAS28 score (a tool that combines joint counts and a blood test result into a number between 0 and 10, where higher numbers reflect more active disease). The reported data shows that participants' average DAS28 score started at around 5.96 at the beginning of the study. By the end of the follow-up period, the average score had fallen to around 2.52. In terms of the proportion of people reaching certain thresholds: at the study's final recorded visit, about 69% of participants were reported to have reached "low disease activity" (a DAS28 score of 3.2 or below), and about 55% were reported to have reached "remission" (a score below 2.6). The reported data shows that among those who did reach low disease activity, the median time to do so was 63 days, while the median time to reach remission was 112 days. Using a separate response scale (EULAR criteria), roughly 57% of participants were categorised as "good responders" at the final visit. Using the ACR improvement scale, the reported data shows that at the final visit, approximately 61% of participants met the threshold for a 20% improvement in joint and symptom measures, around 36% met the 50% improvement threshold, and about 18% met the 70% improvement threshold. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00883753 · results posted 6 August 2014

    According to the results reported on ClinicalTrials.gov, this trial (NCT00883753) enrolled 934 people, all of whom received a medicine called tocilizumab. It was an extension study, meaning participants had already taken part in an earlier ("core") trial and continued into this longer follow-up phase. Of the 934 who started, 827 completed the study and 107 did not. The trial's main focus was tracking unwanted or unexpected health events (called adverse events) and more serious health events (serious adverse events) that occurred while participants were taking the medicine. The reported data shows that the percentage of participants who experienced any adverse event varied depending on how many other arthritis medicines (called DMARDs) they were also taking: 65.0% among those taking tocilizumab alone, 68.6% among those also taking one other DMARD, and 73.2% among those taking more than one other DMARD. Serious adverse events were reported in 8.5%, 5.7%, and 7.3% of participants in those same three groups, respectively. Across all participants, 4.0% stopped taking the medicine due to an adverse event, and the reported median time from the start of the core study to stopping for this reason was 374.5 days. Overall, 11.5% of participants stopped treatment for any reason, with a reported median time to stopping of 339 days. The reported data also shows that some participants had notable changes in their blood fat (lipid) levels during the extension study. Specifically, 14.9% had a high LDL cholesterol reading at some point, 6.5% had a low HDL cholesterol reading, 4.2% had a high total cholesterol reading, and 0.0% had a high triglyceride reading recorded as a marked abnormality. These figures describe what was measured and recorded; they do not indicate what caused these changes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00504777 · results posted 4 August 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 36 adults who were given a combination of rituximab and methotrexate. Thirty-five of the 36 participants completed the study, and one did not. The trial was measuring changes in rheumatoid arthritis disease activity and physical function over time, using several scoring tools that track things like joint swelling, joint tenderness, and how much difficulty people have with everyday tasks. The reported data shows that on the main measure — a disease activity score based on 28 joints (called DAS28, where higher scores mean more active disease) — the average score at the start of the study was 5.51, and by the end it was 4.39, a reported change of −1.12 points. For the secondary measures, the reported data shows that when participants were rated using a European response scale at week 24, approximately 58% fell into the "moderate response" category and about 42% fell into the "no response" category, with 0% recorded as a "good response." On a separate measure of improvement (ACR response), approximately 2.78% of participants were reported as reaching the 20% improvement threshold, and 0% reached the 50% or 70% improvement thresholds. On the everyday physical function questionnaire (HAQ-DI, scored 0–3 where higher means more difficulty), the average score moved from 1.07 at the start to 0.81 at the end, a reported change of −0.26 points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01063062 · results posted 4 August 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 107 people with rheumatoid arthritis across two groups: 30 received tocilizumab on its own, and 77 received tocilizumab combined with another medicine called methotrexate (MTX). The trial was measuring how many participants reached certain scores on a standard disease activity scale called the DAS28 — a tool that uses joint counts and other markers to give a number between 0 and roughly 10, where lower numbers indicate less disease activity. Specifically, the trial tracked how many people reached a "low disease activity" threshold (a score below 3.2) and a "remission" threshold (a score below 2.6), as well as how quickly those thresholds were reached. The reported data shows that, by the final measurement point, around 59% of the tocilizumab-alone group and around 59% of the tocilizumab-plus-MTX group had reached the low disease activity threshold. The reported average time to first reaching that threshold was approximately 107 days for the tocilizumab-alone group and around 100 days for the combination group. For the remission threshold (a stricter, lower score), the reported data shows approximately 48% of the tocilizumab-alone group and around 41% of the tocilizumab-plus-MTX group had reached that level by the final point, with an average time of roughly 116 days and 121 days respectively. A separate secondary measure looked at a meaningful improvement in the score (a drop of at least 1.2 points from the starting score): the reported data shows approximately 86% of the tocilizumab-alone group and around 96% of the combination group had reached that level by the final measurement. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01004432 · results posted 13 May 2014

    According to the results reported on ClinicalTrials.gov, this trial (NCT01004432) enrolled 433 participants in its opening phase, all of whom received golimumab (a 50 mg injection under the skin) together with methotrexate. The trial was designed to measure how participants with rheumatoid arthritis responded to this treatment combination over several stages, running from an open-label period (where everyone knew what they were receiving) through to a double-blind period (where some participants and their doctors did not know which version of the treatment was being given) and a later extension phase. The main thing the trial was measuring was whether participants showed at least a 20% improvement across a set of standard rheumatoid arthritis markers — including joint tenderness, joint swelling, pain scores, and a blood test result — at week 14. The reported data shows that at the primary measurement point (week 14), approximately 34.9% of participants in the overall open-label group met that 20% improvement threshold. At the earlier two-week mark, the reported figure was lower, at around 24.5%. For a subgroup who had responded well by week 16 and were tracked to see whether that response held through to week 52, approximately 22.7% were reported to have maintained that level of improvement. In the double-blind phase, when measuring a similar improvement threshold at week 52 compared to week 16, the reported figures were 13.2% for one group (receiving the injection form) and 9.2% for another (receiving the intravenous form). At the final week-76 point, the reported proportions meeting the improvement threshold ranged from approximately 7.9% to 17.6% depending on the group and the specific blood marker used. The reported data also shows disease activity scores (on a scale of 0 to 9.4, where higher numbers mean more active disease) at week 76. Scores at that point ranged from around 3.2 to 4.4 across the different groups, with the changes in score from week 52 to week 76 being small — ranging from approximately −0.14 to +0.21 — meaning disease activity levels appeared relatively stable across that final period, according to the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01023256 · results posted 8 May 2014

    According to the results reported on ClinicalTrials.gov, this trial tested three different doses of a drug called MOR103 (0.3 mg/kg, 1.0 mg/kg, and 1.5 mg/kg) against a placebo (an inactive treatment) in people with rheumatoid arthritis. A total of 98 people started the trial — 25 in the lowest dose group, 22 in the middle dose group, 24 in the highest dose group, and 27 in the placebo group. The trial's main focus was on tracking unwanted side effects, while secondary measurements looked at joint disease activity scores, the number of swollen and tender joints, and how many participants showed a certain level of improvement in their symptoms. The reported data shows that between 54% and 65% of participants in the MOR103 dose groups experienced a treatment-emergent adverse event (an unwanted health event that occurred during the trial), compared with 44% in the placebo group. Serious adverse events were reported in 4.2% of the lowest dose group and 0% in the other two MOR103 groups, compared with 3.7% in the placebo group. For the disease activity score (a scale from 0 to 9.3, where higher means more active disease), the reported data shows small reductions from the starting point across all groups at both 4 and 8 weeks, with the middle dose group (1.0 mg/kg) showing the largest reported change (−1.1 at 4 weeks and −1.0 at 8 weeks), while the placebo group showed little change (0.2 at 4 weeks and −0.1 at 8 weeks). The reported data also shows that 68% of participants in the middle dose group met a benchmark for symptom improvement (called ACR20, meaning at least 20% improvement across several joint and symptom measures) at week 4, compared with 25%, 30%, and 7.4% in the low dose, high dose, and placebo groups respectively. Regarding joint counts, the reported data shows reductions in swollen and tender joints across MOR103 groups at both 4 and 8 weeks, with the middle and highest dose groups showing somewhat larger reductions than the lowest dose group or placebo. MRI scan scores measuring joint inflammation were also reported, with all groups — including placebo — showing small reductions from their starting scores at week 4; these numbers ranged from −0.37 to −1.50 across the MOR103 groups, compared with −0.66 in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01264770 · results posted 6 May 2014

    According to the results reported on ClinicalTrials.gov, this trial (NCT01264770) enrolled 265 people with rheumatoid arthritis across six groups. The groups were given different doses or schedules of a medicine called fostamatinib (FOSTA) taken by mouth, a comparison medicine called adalimumab given by injection under the skin, or a placebo (dummy treatment) for the first six weeks before switching to fostamatinib. The trial was measuring changes in rheumatoid arthritis disease activity, using a scoring system called DAS28-CRP — a number calculated from swollen and tender joint counts, a blood inflammation test, and the patient's own rating of their condition. A larger drop in this score from the starting point indicates a greater reduction in measured disease activity. The reported data shows that at six weeks, the average drop in DAS28-CRP score from the starting point ranged from about 0.6 to 1.1 units across the fostamatinib groups, compared to 0.6 units in the placebo group. At 24 weeks, the average drop ranged from about 1.0 to 1.4 units across the fostamatinib groups, while the adalimumab group showed a reported drop of 1.8 units. For a secondary measure — the proportion of participants meeting a standard response threshold (ACR20, meaning at least a 20% improvement across several joint and inflammation measures) at 24 weeks — the reported figures ranged from roughly 35% to 56% across the fostamatinib groups, and about 59% in the adalimumab group. For a stricter threshold (ACR50, meaning at least 50% improvement), reported figures across fostamatinib groups ranged from approximately 7% to 20%, compared to about 32% for adalimumab. Some group comparisons were listed as not reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01181050 · results posted 28 April 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 63 adults in total — 41 people received the active treatment (a dose of 4.0 mg/kg of the study drug) and 22 received a placebo (an inactive dummy treatment). All 63 participants completed the study. The trial was measuring changes in a scoring system called DAS28-CRP, which combines information about tender and swollen joints, a blood marker of inflammation, and the participant's own rating of their disease severity into a single number — a lower score means less severe disease. The reported data shows that the main result, measured at 12 weeks, was a reduction of 1.0 points in the DAS28-CRP score in the treatment group and also a reduction of 1.0 points in the placebo group. At the 6-week check-in, the reported reduction was 0.9 points in the treatment group and 1.0 points in the placebo group. At 24 weeks, both groups showed a reported reduction of 1.3 points. In all three time points, the reported changes in score were numerically very similar between the treatment and placebo groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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  • NCT01563978 · results posted 14 April 2014

    According to the results reported on ClinicalTrials.gov, this trial (NCT01563978) enrolled 135 participants in total — 68 in the group receiving a medicine called fostamatin (FOSTA) at 100 mg twice daily, and 67 in a placebo group (a dummy treatment with no active ingredient). Most participants finished the trial: 64 in the fostamatin group and 65 in the placebo group. The trial was measuring changes in blood pressure — specifically systolic blood pressure (the "top" number in a blood pressure reading) and diastolic blood pressure (the "bottom" number) — using monitors worn over 24 hours as well as readings taken in a clinic. The reported data shows that, for the main measure — the change in average 24-hour systolic blood pressure — the fostamatin group showed a reduction of 4.3 mmHg (millimetres of mercury, the standard unit for blood pressure) from their starting level, while the placebo group showed a reduction of 1.3 mmHg. For the 24-hour diastolic (bottom number) reading, the reported reductions were 4.4 mmHg for the fostamatin group and 0.7 mmHg for the placebo group. The reported data also shows reductions across other timepoints: during daytime hours, the fostamatin group's systolic reading fell by 4.9 mmHg versus 1.6 mmHg for placebo; during sleeping hours, the figures were 2.4 mmHg versus 0.7 mmHg. For clinic-based blood pressure readings, the fostamatin group's systolic reading fell by 3.8 mmHg compared with 2.9 mmHg in the placebo group, and the diastolic reading fell by 2.7 mmHg versus 0.7 mmHg. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01077258 · results posted 8 April 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 4,208 people with rheumatoid arthritis. A total of 1,640 participants completed the study, while 2,568 did not complete it. The trial was observational — meaning it watched what happened in real-world care rather than testing a new treatment against a placebo — and tracked how participants' rheumatoid arthritis activity changed over time using a scoring system called the DAS28. This score runs from 0 to 10, where higher numbers mean more active disease; a score below 2.6 is considered remission (very low or no active disease). The reported data shows that, on average, participants' DAS28 scores fell progressively over the course of the study — dropping by approximately 1.5 points at the earliest time point measured and by around 2.2 points by the final time point. The percentage of participants whose scores fell into the remission range (below 2.6) rose from about 18% at the first follow-up to roughly 35% by the end of the study. For a secondary measure — defined as a score improvement of at least 1.8 points, considered a meaningful individual response — the reported data shows this threshold was reached by approximately 39% of participants at the earliest time point, rising to about 62% by the final time point. Two blood markers associated with inflammation — ESR and CRP — were also tracked. The reported data shows both started above typical reference ranges (ESR 32.1 mm/hour; CRP 20.0 mg/L) and were lower at each subsequent time point measured, reaching 21.2 mm/hour and 5.7 mg/L respectively by the study's end. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00254293 · results posted 8 April 2014

    According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called abatacept, given to people with active rheumatoid arthritis (a condition causing joint inflammation) who were already taking other arthritis medicines known as DMARDs. The trial had two main stages: a short 12-week randomised phase where participants were split into five different dose groups or a placebo (dummy treatment) group, and a longer open-label phase where dosing continued. In total, across all groups and phases, roughly 68 people took part in the short-term stage and around 63 entered the longer-term stage. The trial was primarily measuring how much of the medicine was present in participants' blood at certain points in time — this is a way of understanding how the body handles the drug, not a direct measure of whether symptoms improved. The reported data shows that the main thing being tracked was the lowest level of abatacept in the blood between doses (called the "trough" level), measured in micrograms per millilitre (µg/mL) — think of it as measuring how much medicine was still circulating just before the next dose was due. Across the five dose groups, these trough levels ranged from approximately 16 µg/mL (in the group receiving 1000 mg by drip and 125 mg by injection, body weight over 100 kg) up to about 28 µg/mL (in the group receiving 500 mg by drip and 125 mg by injection, body weight under 60 kg). The reported data also shows peak blood levels (the highest concentration after a dose) ranging from about 14.7 µg/mL to 41.7 µg/mL across groups. For unwanted events during the short-term phase, no deaths or discontinuations due to adverse events were reported in any group; a small number of participants across groups experienced serious adverse events (for example, 1 participant in Group 2 and 1 in Group 5). During the longer-term phase, the reported data shows 19 participants experienced adverse events and 4 experienced serious adverse events across the three longer-term dose groups, with 1 death reported in one group (125 mg SC). Infection-related events were the most commonly noted special-interest events in the short-term phase. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01374971 · results posted 8 April 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 12 people with rheumatoid arthritis, all of whom received the study drug certolizumab pegol (also called CZP). Eleven of the 12 participants completed the study, and one did not finish. The trial was measuring changes in certain biological markers (substances found in joint tissue that can reflect what is happening inside the joint) taken from tissue samples, as well as changes in a standard disease activity score used in rheumatoid arthritis care. The reported data shows that joint tissue samples were taken at the start of the study and again after 12 weeks of treatment. Levels of the various biological markers changed by different amounts over that time. Some markers went down — for example, one marker (CXCL13) showed a reported decrease of around 53%, and another (BCL3) decreased by around 32% — while others went up, including one marker (IL-10) that showed a reported increase of around 205% and another (CD79A) that increased by around 110%. Other markers showed smaller changes in either direction. Because the data as submitted lists percentage changes without labelling each number to each specific marker beyond the order listed, only these broad patterns can be described here. For the secondary outcome, the reported data shows that a composite disease activity score known as the DAS28 ESR — which combines joint tenderness and swelling counts, a blood inflammation marker, and a patient's own rating of how arthritis is affecting them — showed a mean (average) percentage decrease of 27.5% from the start of the study to week 14 across all participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01197521 · results posted 7 April 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 918 people across three groups. One group (310 people) took fostamatinib 100 mg twice a day by mouth throughout the study. A second group (304 people) started on fostamatinib 100 mg twice a day, then switched to 150 mg once a day after four weeks. A third group (304 people) took a placebo (a dummy tablet with no active ingredient) for 24 weeks, then switched to fostamatinib 100 mg twice a day. The trial was measuring how well fostamatinib reduced signs of rheumatoid arthritis activity compared to placebo, and whether it slowed joint damage visible on X-rays, over 24 weeks. The reported data shows that at the 24-week mark, 49% of people in the first fostamatinib group and 44.4% in the second fostamatinib group met the trial's main measure of improvement in joint symptoms — compared with 34.2% in the placebo group. For joint damage visible on X-rays (scored on a scale of 0 to 448, where higher numbers mean more damage), the reported average change from the start of the trial was 0.45 points in the first fostamatinib group and 1.29 points in the second, compared with 0.13 points in the placebo group. For secondary measures, the reported data shows that after just one week, about 18.2% of combined fostamatinib participants met the improvement threshold, versus 4.9% in the placebo group. At 24 weeks, the proportions meeting higher improvement thresholds (a 50% or 70% improvement in symptoms) were also reported as higher in the fostamatinib groups than in the placebo group. The reported data also shows an overall average symptom improvement score at 24 weeks of 26.1% for the first fostamatinib group and 20.1% for the second, compared with 12.9% for the placebo group. These numbers describe what was measured and recorded in this trial; they do not account for individual variation between patients, and not all participants completed the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01242514 · results posted 4 April 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 1,912 people across three groups: 1,343 received fostamatinib 100 mg twice daily, 357 received fostamatinib 150 mg once daily, and 212 received fostamatinib 100 mg once daily. The trial was measuring adverse events (unwanted health events that occurred during the study) as its main focus, and also tracked joint disease activity, physical disability, and X-ray evidence of joint damage as secondary measures. Notably, the data shows that none of the participants were recorded as having "completed" the study, and all were listed as "not completed," though the reasons for this are not explained in the submitted data. The reported data shows that the main thing measured was the percentage of participants who experienced at least one adverse event. Across the three groups, this was reported as 74.4%, 70.3%, and 69.8% respectively. Serious adverse events were reported for 11.4%, 8.7%, and 5.7% of participants across the three groups. For the secondary measures, joint disease activity scores (on a scale where lower is better) were reported at similar levels across all groups at the start of the study and at later time points. Physical disability scores (on a scale of 0 to 3, where higher means more difficulty) were reported as approximately 1.0–1.2 across all groups throughout the study. X-ray joint damage scores were also reported at various time points, though some data points appear to be missing or not reported for certain groups and time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01484561 · results posted 2 April 2014

    According to the results reported on ClinicalTrials.gov, this trial (NCT01484561) involved 148 participants in total — 97 in a group that received the active drug CP-690,550 (also known as tofacitinib) followed by a placebo, and 51 in a group that received a placebo in both periods. The trial was measuring how the drug affected kidney function, specifically something called the glomerular filtration rate (GFR) — a measure of how well the kidneys filter fluid. GFR was assessed in two ways: directly measured (mGFR) and estimated using a formula (eGFR). By the end of the study, 88 participants in the first group and 45 in the second group had completed the trial. The reported data shows that kidney function — expressed as a "fold change" from the starting point (where 1.0 would mean no change, above 1.0 would mean an increase, and below 1.0 would mean a decrease) — changed only modestly in both groups across the study periods. For the primary outcome, the directly measured kidney function at the end of the first period showed a fold change of 0.91 in the CP-690,550/Placebo group and 0.99 in the Placebo/Placebo group. For the secondary outcomes, fold changes in both the directly measured and formula-estimated kidney function at later timepoints ranged from approximately 0.92 to 1.04 across both groups, representing similarly small changes from baseline in each case. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00264550 · results posted 21 March 2014

    According to the results reported on ClinicalTrials.gov, this trial (NCT00264550) enrolled 444 people with rheumatoid arthritis across four groups. Participants received either a placebo plus methotrexate (133 people), golimumab 100 mg plus a placebo (133 people), golimumab 50 mg plus methotrexate (89 people), or golimumab 100 mg plus methotrexate (89 people). The trial was measuring things like joint swelling and tenderness, participants' ability to perform everyday tasks, and signs of joint damage over a period of up to 24 weeks. The reported data shows that at week 14, the number of participants who met a standard measure of joint improvement (called an "ACR 20 response" — meaning at least a 20% improvement in swollen and tender joint counts alongside improvements in several other measures) was: 44 out of 133 in the placebo plus methotrexate group, 59 out of 133 in the golimumab 100 mg plus placebo group, 49 out of 89 in the golimumab 50 mg plus methotrexate group, and 50 out of 89 in the golimumab 100 mg plus methotrexate group. For everyday physical function (scored on a scale from 0 to 3, where 0 means no difficulty), the reported average improvement from the starting point at week 24 was 0.125 points in both the placebo plus methotrexate and golimumab 100 mg plus placebo groups, 0.375 points in the golimumab 50 mg plus methotrexate group, and 0.500 points in the golimumab 100 mg plus methotrexate group. For the measure of joint damage on X-ray at week 24, all four groups reported a change of 0.00 on that scale, meaning no change from the starting point was recorded in any group. The reported data also shows that at week 24, the number of participants meeting the ACR 20 response threshold was 37 in the placebo plus methotrexate group, 47 in the golimumab 100 mg plus placebo group, and 53 each in both golimumab plus methotrexate groups. A separate disease activity score (called DAS 28, a combined measure of joint counts, a blood marker, and the participant's own rating) showed a response in 67 of 133 participants in the placebo plus methotrexate group, 84 of 133 in the golimumab 100 mg plus placebo group, 64 of 89 in the golimumab 50 mg plus methotrexate group, and 67 of 89 in the golimumab 100 mg plus methotrexate group at week 14. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01185288 · results posted 18 March 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 309 people with rheumatoid arthritis — 154 in one group and 155 in another. Both groups received the same medication, adalimumab, but were paired with different doses of a second medication, methotrexate: one group received a low dose and the other a high dose. The trial ran for 24 weeks and was mainly measuring joint disease activity using a scoring tool called the DAS28(CRP), which runs from 0 to 10, where higher numbers mean more active disease (a score below 2.6 is considered remission, and above 5.1 is considered high activity). By the end of the study, 135 people in the low-dose group and 139 in the high-dose group had completed the trial. The reported data shows that at 24 weeks, the average DAS28(CRP) score was 4.11 in the low-dose methotrexate group and 3.75 in the high-dose methotrexate group. For the secondary measures, the reported data shows that around 45% of the low-dose group and 52% of the high-dose group had at least a 30% improvement in an ultrasound measure of joint inflammation. Roughly 30% of the low-dose group and 38% of the high-dose group met a standard measure of meaningful improvement across multiple joint symptoms (called ACR50), while about 13% and 20% respectively met an even stricter version of that measure (ACR70). Around 64% and 66% of participants in each group respectively showed a meaningful improvement in a self-reported physical function questionnaire. Both groups also reported a reduction in sleep problems, with the low-dose group showing roughly a 15% reduction and the high-dose group roughly a 17% reduction in their sleep problem score. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01502423 · results posted 20 February 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 61 adults across two groups. It was a crossover study, meaning participants in both groups received both versions of the medicine — adalimumab in its current formulation and a new formulation — just in a different order. The trial was primarily measuring how much pain people felt at the injection site immediately after receiving each injection, using a simple 0–10 scale (where 0 means no pain and 10 means the worst imaginable pain). The reported data shows that, right after injection, the average pain score for the current formulation was 4.2 out of 10, compared to 0.9 out of 10 for the new formulation. Fifteen minutes after the injection, the reported average pain scores had dropped for both — to 1.0 out of 10 for the current formulation and 0.4 out of 10 for the new formulation. The trial also measured injection site reactions at the skin. For the new formulation, the reported data shows that around 90–92% of participants had no bleeding or spots under the skin at the injection site, compared with around 80–82% for the current formulation. For redness at the injection site, roughly 63–75% of participants had none with the new formulation, versus around 50–60% with the current formulation. For swelling, approximately 93–95% had none with the new formulation, compared to around 90–92% with the current formulation. For itching, the figures were similar between the two — around 95–97% for the new formulation and 97–98% for the current formulation. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01235598 · results posted 5 February 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 41 people with rheumatoid arthritis across two groups: 13 participants received a placebo first and then switched to certolizumab pegol (CZP), while 28 participants received CZP from the start. Of those, 12 and 24 respectively completed the study. The trial was measuring joint inflammation (called synovitis) in the hands and wrists using a special type of MRI scan, tracked at several points over 16 weeks. The scoring system used — known as RAMRIS — runs from 0 (no inflammation) to 21 (most severe), with a lower score over time suggesting a reduction in inflammation. The reported data shows changes in the RAMRIS synovitis score for the CZP group compared to where they started (baseline). At week 1, the reported change was −0.6 points; at week 2, −0.4 points; at week 4, −0.4 points; at week 8, −0.7 points; and at week 16, −1.0 points. A negative number on this scale means the score moved downward from baseline. No comparison numbers for the placebo group were reported in the primary outcome data submitted. One secondary outcome also measured inflammation using a different MRI technique (looking at how quickly contrast dye spreads into joint tissue); the reported change from baseline to week 16 was −0.0044 percent per second for the CZP group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01464021 · results posted 30 January 2014

    According to the results reported on ClinicalTrials.gov, this trial (NCT01464021) enrolled 26 participants, all of whom received the drug adalimumab. The trial was measuring responses in people with rheumatoid arthritis, a condition causing joint inflammation and pain. The main thing being tracked was whether participants showed at least a "moderate response" on a standard rheumatology scoring system called the DAS28, which rates disease activity on a scale from 0 to 10 — higher scores mean more active disease. Notably, the reported data shows that none of the 26 participants were recorded as having completed the study, and all 26 were listed under "not completed," though no further explanation for this is provided in the data. The reported data shows that, for the primary outcome, 9 out of 26 participants were recorded as having achieved at least a moderate EULAR response — meaning their DAS28 score improved by a defined amount from the start of the trial. For the secondary outcomes, the data reports percentage changes from the starting point across what appear to be multiple time points during the study. The DAS28 score (measured using a blood marker called ESR) showed reported changes ranging from around −34% to −62%. The number of tender and swollen joints showed reported changes ranging from approximately −44% to −97%. Participants' own ratings of how their disease felt showed reported changes ranging from around −45% to −66%. C-reactive protein — another blood marker of inflammation — showed more varied results, with some time points reporting increases (up to about +206%) and others reporting decreases (down to about −82%). The data as submitted does not label which time points these individual figures belong to, so a full breakdown cannot be provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01163292 · results posted 11 December 2013

    According to the results reported on ClinicalTrials.gov, this trial (NCT01163292) involved people with rheumatoid arthritis — a condition where the immune system attacks the joints. A total of 220 people took part: 106 in the adalimumab group (a medicine used for arthritis) and 114 in a non-adalimumab group (people treated without that particular medicine). By the end of the study, 65 people in the adalimumab group and 92 in the non-adalimumab group had completed it. The trial tracked joint disease activity, physical function, joint damage on X-rays, a blood marker of inflammation, and the number of participants who experienced unwanted health events (adverse events). The reported data shows that disease activity — measured on a scoring system called DAS28, which runs from 0 (no disease activity) to 9 (maximum) — was recorded at several points across the study. Scores for the adalimumab group were reported as approximately 2.93, 2.72, and 2.70 at different time points, while scores for the non-adalimumab group were approximately 2.73, 3.17, and 3.20. For physical function (HAQ-DI, scored 0–3 where lower means fewer difficulties), the reported scores ranged from roughly 0.20 to 0.27 in the adalimumab group and 0.24 to 0.26 in the non-adalimumab group. Joint damage on X-ray (mTSS, scored 0–380) changed by an average of 0.8 units in the adalimumab group and 0.6 units in the non-adalimumab group over 52 weeks. For the blood marker MMP-3, the data shows counts of participants at various time points rather than a single summary figure, so a straightforward comparison is not possible from the numbers as reported. Regarding adverse events, 51 participants in the adalimumab group and 39 in the non-adalimumab group were reported as having experienced at least one adverse event; however, the data as submitted does not break these down further in this section. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01232569 · results posted 23 October 2013

    According to the results reported on ClinicalTrials.gov, this trial involved 656 participants across two main stages. In the first stage (the double-blind period), 438 people received a subcutaneous (under-the-skin) injection of tocilizumab and 218 received a placebo (a dummy injection with no active medicine), with neither participants nor researchers knowing who received which treatment. In the second stage (an open-label extension, where everyone knew what was being given), 457 participants continued on tocilizumab — some using a pre-filled syringe and some using an auto-injector device. The trial was primarily measuring how many participants showed a meaningful improvement in their joint symptoms and related measures at 24 weeks, using a standard rheumatology scoring system called the ACR20 (which requires at least a 20% improvement across several disease markers). The reported data shows that at 24 weeks, 60.9% of participants in the tocilizumab group met the ACR20 response threshold, compared with 31.5% in the placebo group. For a higher level of improvement (ACR50, meaning at least 50% improvement), the reported figures were 39.8% for the tocilizumab group and 12.3% for the placebo group; for ACR70 (at least 70% improvement), the figures were 19.7% and 5.0% respectively. The reported data also shows that the median time to first reaching the ACR20 response level was 57 days in the tocilizumab group and 86 days in the placebo group. For ACR50 and ACR70 responses, median times were not reported for the placebo group. Changes in two inflammation markers — C-reactive protein and erythrocyte sedimentation rate (both blood tests used to measure inflammation in the body) — were also reported, with larger reductions seen in the tocilizumab group than the placebo group at 24 weeks. Similarly, the average number of tender and swollen joints reported decreased more in the tocilizumab group than in the placebo group over the same period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00721123 · results posted 21 October 2013

    According to the results reported on ClinicalTrials.gov, this trial enrolled 538 people, all of whom received tocilizumab at a dose of 8 mg/kg. The trial followed participants with rheumatoid arthritis (a condition where the immune system attacks the joints) for up to five years. Of the 538 who started, 355 completed the study and 183 did not finish. The trial's primary focus was tracking how many participants experienced any unwanted health events (called adverse events) across successive yearly periods, and a range of secondary measurements looked at joint symptoms, disease activity, and everyday physical functioning over time. The reported data shows that, for the primary measure — the count of participants who experienced at least one unwanted health event in each yearly period — the numbers were: 433 participants in the first year, 390 in the second, 333 in the third, 294 in the fourth, and 329 in the fifth (noting that the study notes this last figure reflects the participants still in the trial at that stage, so direct year-to-year comparison should be treated with caution). For the secondary measures, using a standard rheumatoid arthritis symptom score (ACR20, meaning at least a 20% improvement across key joint and health measures), the reported percentage of participants reaching that threshold rose from 63.2% at week 24 to 83.9% at week 264. A stricter improvement threshold (ACR50, meaning at least 50% improvement) went from 41.2% at week 24 to 67.8% at week 264. Reported data also shows that the percentage of participants whose disease activity score fell into the "remission" category (a very low score on a 0–10 scale) rose from 24.6% at week 24 to 60.6% at week 264. Average swollen joint counts (out of 66 assessed joints) changed by −11.7 joints at week 24 and −16.5 joints at week 264 from where they started, and tender joint counts (out of 68 joints) changed by −17.4 and −24.8 respectively — with a negative number indicating a reduction. A questionnaire measuring everyday physical difficulty (scored 0–3, where lower is less difficulty) showed an average change of −0.49 points at week 24 and −0.62 points at week 264 from the starting score. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00973479 · results posted 14 October 2013

    According to the results reported on ClinicalTrials.gov, this trial enrolled 592 people in total — 197 in the placebo-plus-methotrexate group and 395 in the golimumab-plus-methotrexate group. The study was looking at people with rheumatoid arthritis (a condition causing joint pain and swelling) and was primarily measuring how many participants showed a meaningful improvement in their joint symptoms and overall disease signs by week 14. A number of secondary measures were also tracked, including physical function, disease activity scores, and X-ray evidence of joint damage. The reported data shows that by week 14, around 24.9% of participants in the placebo-plus-methotrexate group met the main improvement target (called an ACR 20 response — meaning at least 20% improvement across several joint and wellbeing measures), compared with 58.5% in the golimumab-plus-methotrexate group. For the secondary measures at week 14, the reported data shows that 40.1% of the placebo group showed a moderate or good improvement on a standard disease activity score (DAS28), compared with 81.3% in the golimumab group. On a physical function questionnaire scored from 0 (no difficulty) to 3 (completely unable), the placebo group's score improved by an average of 0.125 points, while the golimumab group improved by an average of 0.500 points. By week 24, around 13.2% of the placebo group reached an even higher improvement target (ACR 50 — at least 50% improvement), compared with 34.9% in the golimumab group. On an X-ray-based measure of joint damage (scored from 0 to 448, where higher numbers mean more damage), the placebo group showed an average change of +1.09 points from the start, while the golimumab group showed an average change of +0.03 points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01007435 · results posted 12 July 2013

    According to the results reported on ClinicalTrials.gov, this trial enrolled 1,162 adults with rheumatoid arthritis across four treatment groups. Participants received either a placebo plus methotrexate, a lower dose of tocilizumab (4 mg/kg) plus methotrexate, a higher dose of tocilizumab (8 mg/kg) plus methotrexate, or the higher dose of tocilizumab plus a placebo instead of methotrexate. The trial measured disease activity using a scoring tool called DAS28 — a number calculated from joint counts, a blood marker of inflammation, and the patient's own rating of how they felt. A DAS28 score below 2.6 is considered "remission" (very low disease activity). The trial also tracked joint damage over time using X-ray scoring tools. The reported data shows that at 24 weeks, the percentage of participants whose DAS28 score fell into the remission range was 15.0% in the placebo-plus-methotrexate group, 31.9% in the lower-dose tocilizumab-plus-methotrexate group, 44.8% in the higher-dose tocilizumab-plus-methotrexate group, and 38.7% in the higher-dose tocilizumab-plus-placebo group. At 52 weeks, those figures were reported as 19.5%, 34.0%, 49.0%, and 39.4% respectively. The reported data also shows that changes in X-ray scores for joint damage at 52 weeks were small across all groups, with the placebo-plus-methotrexate group showing the largest average increase (1.14 points on a scale of 0–448), and the higher-dose tocilizumab-plus-methotrexate group showing the smallest average increase (0.08 points). Scores for a separate measure of joint improvement (the ACR score, which tracks swollen and tender joints alongside other symptoms) at both 24 and 52 weeks were also reported across the groups, but the data as submitted combines multiple time points and improvement thresholds together, so individual figures for each time point were not separately reported in a way that can be clearly distinguished. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01248780 · results posted 1 July 2013

    According to the results reported on ClinicalTrials.gov, this trial (NCT01248780) enrolled 264 people with rheumatoid arthritis — 132 in each group. One group received a placebo (an inactive treatment) combined with methotrexate (a common arthritis medicine, referred to as MTX), and the other group received golimumab 50 mg combined with MTX. The trial was mainly measuring how many participants showed a meaningful reduction in rheumatoid arthritis symptoms and disease activity by week 14, using a standard assessment called the ACR 20 — which counts someone as a "responder" if their recorded symptoms improve by at least 20%. The reported data shows that at week 14 (the primary measurement point), 21 out of 132 participants in the placebo-plus-MTX group met the ACR 20 response threshold, compared with 54 out of 132 in the golimumab-plus-MTX group. For a secondary measure looking at joint activity scores (called DAS28, a scale where higher scores mean more active disease), 40 participants in the placebo-plus-MTX group were classed as responders at week 14, compared with 86 in the golimumab-plus-MTX group. At week 24, the reported data shows 21 placebo-plus-MTX participants and 56 golimumab-plus-MTX participants met the ACR 20 threshold. The reported data also shows a secondary measure of how much difficulty participants had with everyday tasks (such as dressing, eating, and walking), scored on a scale from 0 to 3 where 0 means no difficulty. At week 24, the placebo-plus-MTX group's average score on this scale changed by +0.15 from their starting point (meaning slightly more reported difficulty), while the golimumab-plus-MTX group's average score changed by −0.26 (meaning slightly less reported difficulty). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00299130 · results posted 28 June 2013

    According to the results reported on ClinicalTrials.gov, this trial enrolled 511 adults across three groups, all of whom were also taking methotrexate (a common medicine for joint disease). One group received a placebo (an inactive treatment) plus methotrexate, while the other two groups received different doses of rituximab — either two doses of 0.5 grams or two doses of 1.0 grams — also alongside methotrexate. The trial ran for up to five years and was primarily measuring how many participants showed a meaningful improvement in joint tenderness, joint swelling, pain, and other disease-related measures by 24 weeks. The reported data shows that for the main outcome at 24 weeks — which required at least a 20% improvement across several joint and symptom measures — 23.3% of people in the placebo group met this threshold, compared with 54.5% in the lower-dose rituximab group and 50.6% in the higher-dose rituximab group. For a stricter 50% improvement threshold, the reported figures were 9.3% (placebo), 26.3% (lower-dose rituximab), and 25.9% (higher-dose rituximab). For an even stricter 70% improvement threshold, the reported figures were 5.2%, 9.0%, and 10.0% respectively. The reported data also shows changes in an overall disease activity score (rated from 0 to 10, where higher means more active disease): the placebo group's average score fell by 0.76 points, while both rituximab groups fell by around 1.68–1.71 points. Swollen joint counts also showed percentage reductions across all groups, with larger reductions reported in the rituximab groups than in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00767325 · results posted 21 June 2013

    According to the results reported on ClinicalTrials.gov, this trial enrolled 104 adults who received infusions of abatacept at a dose of 10 mg/kg. Of those, 89 completed the study and 15 did not finish. The trial was measuring changes in joint inflammation in the knuckle joints (the 2nd to 5th knuckles of both hands) using a specialised ultrasound technique called Power Doppler Ultrasonography (PDUS). This technique scores joint inflammation on a scale — a higher score means more severe inflammation, with the total score for both hands ranging from 8 to 24. The trial also looked at how early any changes in that score could be detected, and whether early ultrasound readings might predict how a person would fare clinically later in the study. The reported data shows that, on average, participants' PDUS inflammation scores decreased (got lower) over time compared to their starting scores. The reductions reported at successive time points ranged from −0.7 at the earliest measurement to −4.8 by the later time points, on that 8–24 scale. The reported data also shows that the earliest point at which a meaningful change in the ultrasound score was detected — where the researchers were confident the change was not simply due to chance — was Day 7 of the study. For the secondary outcome looking at whether early ultrasound scores could reliably predict a later clinical response, the reported data shows zero scores met the threshold considered acceptable for prediction across all three clinical response categories examined. Regarding reported adverse events (unexpected or unwanted medical occurrences), the data shows that 62 of the 104 participants experienced at least one adverse event, 22 experienced an adverse event considered possibly related to the study treatment, 6 experienced a serious adverse event, and no deaths were reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00424346 · results posted 19 June 2013

    According to the results reported on ClinicalTrials.gov, this trial tested three different doses of a medicine called canakinumab against a placebo (an inactive treatment) in people with rheumatoid arthritis. A total of 274 people took part in the main part of the study — 71 in the highest-dose group, 64 in the middle-dose group, 69 in the lower-dose group, and 70 in the placebo group. The trial's main question was whether, after 12 weeks, participants showed at least a 50% improvement across several standard measures of joint disease activity (a score known as ACR50, which looks at things like joint swelling, pain, and a blood marker of inflammation). The reported data shows that at the 12-week mark, the percentage of participants who met the ACR50 threshold was 9.9% in the highest-dose canakinumab group, 23.4% in the middle-dose group, 26.5% in the lower-dose group, and 11.4% in the placebo group. Looking at a less strict measure (at least 20% improvement, or ACR20) at week 12, the reported figures were 35.2%, 43.8%, 42.6%, and 27.1% respectively. For the strictest measure (at least 70% improvement, or ACR70) at week 12, the reported percentages were 0%, 4.7%, 5.8%, and 2.9%. The reported data also shows that the average number of swollen joints (out of 28 assessed) fell across all groups over 12 weeks, with reductions ranging from about 3.3 joints in the placebo group to about 4.9 joints in the lower-dose canakinumab group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01359150 · results posted 29 March 2013

    According to the results reported on ClinicalTrials.gov, this trial enrolled 223 people in total — 112 in the group receiving CP-690,550 (also known as tofacitinib) alongside influenza and pneumococcal vaccines, and 111 in the group receiving a placebo alongside the same vaccines. The trial was measuring how well participants' immune systems produced antibodies (proteins the body makes in response to a vaccine) after receiving both vaccines. The main question was whether a "satisfactory" antibody response was reached — meaning antibody levels rose by a meaningful amount against enough of the vaccine targets within about five weeks of vaccination. The reported data shows that for the pneumococcal (pneumonia) vaccine, 45.1% of people in the CP-690,550 group showed a satisfactory antibody response, compared with 68.4% in the placebo group. For the seasonal influenza (flu) vaccine, 56.9% of the CP-690,550 group showed a satisfactory response, compared with 62.2% in the placebo group. Some participants were also taking a medicine called methotrexate at the same time, and the data was broken down separately for those people, though the pattern of results was broadly similar across subgroups. Secondary measurements — looking at responses to individual vaccine targets and at antibody levels reaching a "protective" threshold for influenza — also showed percentage figures that were generally lower in the CP-690,550 group than in the placebo group across most measures reported. The reported data also includes a measure called "geometric mean fold rise," which is simply a way of expressing, on average, how many times higher antibody levels were after vaccination compared to before. For the pneumococcal vaccine antigens, these average rises ranged from about 1.80 to 4.75 in the CP-690,550 group and from about 2.34 to 6.83 in the placebo group, depending on the specific antigen measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00634933 · results posted 11 March 2013

    According to the results reported on ClinicalTrials.gov, this trial enrolled 222 people with rheumatoid arthritis across three groups in the first part of the study: 74 received a placebo (a dummy treatment with no active ingredient), 75 received TRU-015 as a single dose, and 73 received TRU-015 as an induction dose (a higher starting dose). The trial ran in two parts, up to 52 weeks in total, with some participants continuing into a second phase. The main thing the trial set out to measure was how many people in each group achieved at least a 50% improvement across a standard set of rheumatoid arthritis signs — including tender joints, swollen joints, pain, and physical function — by week 24. This is known as an ACR50 response. The reported data shows that at week 24, 16.2% of placebo participants, 29.3% of the TRU-015 single dose group, and 27.4% of the TRU-015 induction dose group met the ACR50 threshold. For the less stringent measure of 20% improvement (ACR20), the reported figures at week 24 were 31.1% for placebo, 34.7% for the single dose group, and 34.2% for the induction dose group — with these figures appearing to climb over later time points, reaching 52.0% and 49.3% respectively for the two TRU-015 groups by the final measurement, compared with 31.1% for placebo. The reported data also shows the average number of tender joints and swollen joints across all three groups decreased over the course of the study, though the data does not report whether these differences between groups were considered statistically meaningful (i.e., unlikely to be due to chance). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00175877 · results posted 8 March 2013

    According to the results reported on ClinicalTrials.gov, this long-term follow-up trial enrolled 846 adults who had previously taken part in an earlier study on certolizumab pegol (CZP), a medicine used for rheumatoid arthritis. All participants in this open-label study received certolizumab pegol, with the overall follow-up period stretching to approximately seven years. The trial was primarily tracking the participants' experiences of medical events (called adverse events) over that extended period, and secondarily measuring changes in arthritis symptoms at set time points. Of the 846 people who started the study, 497 completed it and 349 did not. The reported data shows that when it came to the primary (main) outcomes focused on medical events, 94.9% of participants experienced at least one adverse event — that is, any unwanted medical occurrence during the study period (noting that these are not necessarily caused by the treatment). A total of 41.6% of participants experienced at least one serious adverse event, meaning a medical occurrence considered more significant, such as one requiring hospitalisation. Additionally, 16.2% of participants left the study early because of an adverse event. For the secondary outcomes, the trial tracked what proportion of participants met a standard set of improvement criteria for arthritis symptoms (known as ACR20 — meaning at least a 20% improvement across several measures of joint pain, swelling, and physical function). The reported data shows that among those still participating and assessed at each time point, 87.0% met this improvement threshold at Week 48, 88.0% at Week 96, and 87.9% at Week 144. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01194414 · results posted 12 February 2013

    According to the results reported on ClinicalTrials.gov, this trial (NCT01194414) enrolled 1,262 people with rheumatoid arthritis — 631 in a group receiving tocilizumab by injection under the skin (subcutaneous, or SC) and 631 receiving it through a drip into a vein (intravenous, or IV). The first phase lasted 24 weeks and compared the two delivery methods in a blinded way (meaning participants did not know which form they were receiving). After that, most participants continued into a longer 72-week open-label phase (where the treatment type was known). The trial was measuring how participants' joint symptoms responded over time, as well as tracking any adverse events (unwanted health occurrences), serious adverse events, and notable changes in laboratory test results. The reported data shows that at 24 weeks, 69.4% of participants in the SC group and 73.4% in the IV group met what is called an "ACR20 response" — meaning their joint tenderness, swelling, and several other disease measures had each improved by at least 20% compared to the start of the trial. For a higher threshold of improvement (at least 50%, known as ACR50), the reported figures were 47.0% (SC) and 48.6% (IV); and for at least 70% improvement (ACR70), 24.0% (SC) and 27.9% (IV). Additionally, 38.4% of the SC group and 36.9% of the IV group reached a score considered to be in "remission" on a standard disease activity scale. Around 65.2% (SC) and 67.4% (IV) of participants showed a meaningful improvement in their self-reported ability to carry out daily activities. Regarding adverse events, the reported data shows that 91.6% of the SC group and 87.8% of the IV group experienced at least one adverse event (any unwanted health occurrence) during the study. Serious adverse events were reported in 13.9% (SC) and 12.7% (IV) of participants. Clinically significant changes in laboratory results were noted in 37.7% (SC) and 28.2% (IV). Similar figures were also reported for participants who switched between the two forms of the drug during the open-label phase, though the data as submitted does not clearly separate out which of these three categories each set of numbers belongs to for those switching groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01119859 · results posted 11 February 2013

    According to the results reported on ClinicalTrials.gov, this trial enrolled 163 people in each of two groups — one group received tocilizumab (8 mg/kg) and the other received adalimumab (40 mg). Both are medicines used in rheumatoid arthritis. The trial ran for 24 weeks and was measuring changes in disease activity using a scoring system called the DAS28, which combines information about swollen and tender joints, a blood marker of inflammation, and the patient's own rating of how they felt. A lower DAS28 score means lower disease activity, and a score below 2.6 is considered remission. By the end of the study, 139 people in the tocilizumab group and 133 in the adalimumab group had completed the trial. The reported data shows that, on average, DAS28 scores dropped by 3.3 points in the tocilizumab group and 1.8 points in the adalimumab group from the start of the trial to week 24. For the secondary outcomes, the reported data shows that 39.9% of people in the tocilizumab group reached the remission threshold (DAS28 below 2.6) at week 24, compared with 10.5% in the adalimumab group. Low disease activity (DAS28 at or below 3.2) was reported in 51.5% of the tocilizumab group versus 19.8% of the adalimumab group. Using a separate scoring system (ACR), at least a 20% improvement was reported in 65.0% versus 49.4%; at least a 50% improvement in 47.2% versus 27.8%; and at least a 70% improvement in 32.5% versus 17.9%, for tocilizumab and adalimumab respectively. A "good response" on the EULAR rating system was reported for 51.5% (tocilizumab) versus 19.8% (adalimumab), and a good or moderate response combined was reported for 77.9% versus 54.9%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01262118 · results posted 23 January 2013

    According to the results reported on ClinicalTrials.gov, this trial enrolled 69 people in total — 36 people with rheumatoid arthritis and 33 healthy volunteers. The trial was measuring how cholesterol behaves in the blood, specifically looking at "good cholesterol" (HDL-C) levels and the rate at which a type of cholesterol called cholesterol ester is produced and cleared by the body. The rheumatoid arthritis group went through a six-week treatment period, while the healthy volunteers took part only in the initial baseline measurements for comparison purposes. The reported data shows that at the start of the trial, the rheumatoid arthritis group had an average HDL-C ("good cholesterol") blood level of 54.30 mg/dL, compared to 63.43 mg/dL in the healthy volunteers. After the six-week treatment period, the rheumatoid arthritis group's average HDL-C reading was reported as 62.34 mg/dL. For cholesterol ester production rate, the reported starting figures were very similar between the two groups (1.09 for the rheumatoid arthritis group and 1.11 for healthy volunteers), and the rheumatoid arthritis group's figure at six weeks was reported as 1.12. Regarding the secondary measures, the rheumatoid arthritis group's average LDL-C ("bad cholesterol") was reported as 124.61 mg/dL at baseline and 142.68 mg/dL at six weeks, while total cholesterol was 193.79 mg/dL at baseline and 219.83 mg/dL at six weeks. The six-week figures for the healthy volunteer group were not reported in the data. A measure of how quickly cholesterol ester is processed and removed (fractional catabolic rate) was 2.43%/hr for the rheumatoid arthritis group at baseline versus 2.17%/hr for healthy volunteers, and 2.23%/hr for the rheumatoid arthritis group at six weeks; the healthy volunteer six-week figure was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00960440 · results posted 10 January 2013

    According to the results reported on ClinicalTrials.gov, this trial (NCT00960440) looked at a medicine called CP-690,550 (tested at two dose levels — 5 mg and 10 mg) compared to a dummy treatment (placebo) in people with rheumatoid arthritis. A total of 399 people took part across four groups: 133 received the 5 mg dose, 134 received the 10 mg dose, and 132 received placebo (some of whom later switched to one of the active doses). The trial measured three main things at the 3-month mark: the proportion of participants whose joint tenderness, swelling, pain and other arthritis-related measures improved by at least 20% (called an ACR20 response); how much difficulty participants had with everyday tasks like dressing, eating and walking (scored on a scale of 0 to 3, where 0 means no difficulty); and the proportion of participants whose overall disease activity score fell into a range considered to indicate remission. The reported data shows that at 3 months, approximately 42% of participants in the 5 mg group and 48% in the 10 mg group met the ACR20 improvement threshold, compared with around 24% in the placebo group. For everyday physical tasks, the average difficulty score at the start of the trial was about 1.60 (5 mg group), 1.50 (10 mg group), and 1.63 (placebo group). By 3 months, the reported average change from that starting score was a reduction of 0.41 points in both active-dose groups, compared with a reduction of 0.17 points in the placebo group. Regarding remission-level disease activity scores, approximately 7% of the 5 mg group and 11% of the 10 mg group reached that threshold, versus about 2% of the placebo group. The reported data also shows results at earlier and later time points. At 2 weeks, around 28% (5 mg) and 33% (10 mg) met the ACR20 threshold, compared with 17% on placebo. A stricter measure — at least 50% improvement (ACR50) — was reported in roughly 27% of both active-dose groups at 3 months, compared with about 8% on placebo. At 6 months, after placebo participants had switched to an active dose, ACR20 response rates across all groups ranged from approximately 40% to 55%, though the reported data does not allow a direct comparison with placebo at those later time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00856544 · results posted 10 January 2013

    According to the results reported on ClinicalTrials.gov, this trial enrolled 795 adults in total across four groups. Most participants had rheumatoid arthritis and were already taking methotrexate. The trial tested two doses of a medication called CP-690,550 (5 mg and 10 mg, now known as tofacitinib) against a dummy tablet (placebo) over six months, with some placebo participants then switching to the active medication for a further six months. The trial measured things like joint tenderness and swelling, participants' ability to carry out everyday tasks, and whether participants reached certain recognised thresholds of improvement in their arthritis. The reported data shows that at the six-month mark, 52.7% of participants in the 5 mg group and 58.3% in the 10 mg group met the "ACR20" threshold — meaning at least a 20% improvement across several joint and symptom measures — compared with 31.2% of those in the placebo group. For everyday physical tasks (measured on a scale from 0, no difficulty, to 3, extreme difficulty), the reported average scores at the start were similar across all groups (around 1.35–1.44). By month three, the reported average change from that starting score was −0.45 for the 5 mg group, −0.54 for the 10 mg group, and −0.16 for the placebo group — meaning all groups reported some reduction in difficulty, with the active-medication groups reporting a larger reduction. The reported data also shows that a small percentage of participants reached a score considered to indicate disease "remission" at six months: 9.1% in the 5 mg group, 13.3% in the 10 mg group, and 2.7% in the placebo group. For secondary measures, the reported data shows that at each time point checked (two weeks, one month, two months, three months, four-and-a-half months, and six months), higher percentages of participants in both active-medication groups met the 20% and 50% improvement thresholds compared with the placebo group. At twelve months — by which time former placebo participants had switched to one of the active doses — the reported ACR20 rates across all four groups ranged from approximately 32% to 57%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00853385 · results posted 9 January 2013

    According to the results reported on ClinicalTrials.gov, this trial enrolled 717 people in total across five groups. Most participants had rheumatoid arthritis and were assigned to receive either one of two doses of a medicine called CP-690,550 (5 mg or 10 mg — now known as tofacitinib), a comparison medicine called adalimumab, or a placebo (a dummy treatment with no active ingredient). A smaller group started on placebo and later switched to one of the two CP-690,550 doses. The trial ran for 12 months and was measuring things like joint tenderness and swelling, how easily participants could carry out everyday tasks, and whether their disease activity reached a level considered to be remission. The reported data shows that at the six-month mark, about 52% of participants in the CP-690,550 5 mg group and about 53% in the 10 mg group met a standard benchmark for improvement in joint symptoms (called ACR20, meaning at least a 20% improvement across several joint and symptom measures), compared with about 28% in the placebo group and about 47% in the adalimumab group. For daily physical tasks — scored on a scale where 0 means no difficulty and 3 means extreme difficulty — the reported data shows that at three months, average scores decreased (indicating less difficulty) by 0.49 points in the 5 mg group, 0.59 points in the 10 mg group, 0.17 points in the placebo group, and 0.45 points in the adalimumab group, from starting scores of around 1.42–1.53 across all groups. Regarding remission (defined as a disease activity score below 2.6), at six months approximately 6% of the 5 mg group, 13% of the 10 mg group, 1% of the placebo group, and 7% of the adalimumab group reached that threshold. The reported data also shows that at one month, around 41% (5 mg) and 46% (10 mg) of participants met the ACR20 improvement benchmark, rising to roughly 61% and 59% respectively at three months, compared with about 16% and 26% for the placebo group at those same time points. A higher improvement benchmark (ACR50, meaning at least 50% improvement) was reached by approximately 37% of the 5 mg group and 35% of the 10 mg group at six months, versus about 12% in the placebo group and 28% in the adalimumab group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00847613 · results posted 9 January 2013

    According to the results reported on ClinicalTrials.gov, this trial enrolled 800 people in total across four groups. Around 321 people received a lower dose of the study drug (CP-690,550, now known as tofacitinib) at 5 mg, 319 received a higher dose at 10 mg, and 160 people initially received a placebo (a dummy treatment with no active ingredient) before later switching to one of the two doses. The trial was measuring three main things in people with rheumatoid arthritis: how many participants showed a meaningful improvement in joint symptoms by six months (using a standard checklist called the ACR20); whether joint damage seen on X-rays had changed after six months; and how much difficulty participants had with everyday tasks like dressing, eating, and walking after three months. The reported data shows that at the six-month mark, about 51% of people on the lower dose and 62% on the higher dose met the ACR20 improvement threshold, compared with about 25% of those on placebo. For the X-ray joint damage score (where a higher number means more damage and a lower change from the starting point is considered better), the reported average change from the start of the trial was 0.12 points for the lower dose group, 0.06 points for the higher dose group, and 0.47 points for the placebo group. For everyday task difficulty, the average score (on a scale of 0 to 3, where lower means less difficulty) changed by −0.3 in the lower dose group, −0.4 in the higher dose group, and −0.1 in the placebo group, compared to where each group started. A separate measure looking at how many participants reached a very low disease activity score at six months reported about 7% in the lower dose group, 16% in the higher dose group, and under 2% in the placebo group. The reported data also shows ACR20 response rates were tracked at earlier and later time points as secondary measures. At one month, roughly 41% (lower dose), 52% (higher dose), and 16% (placebo) met the threshold; at three months those figures were approximately 56%, 66%, and 27% respectively. At twelve months — by which time placebo participants had switched to active treatment — the rates were reported as approximately 49% and 57% for the original lower and higher dose groups, and around 30% and 33% for those who had switched from placebo. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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  • NCT00414661 · results posted 1 January 2013

    According to the results reported on ClinicalTrials.gov, this trial (NCT00414661) enrolled 162 people across four groups: 48 received a higher dose of CP-690,550 (now known as tofacitinib, at 10 mg or more), 89 received a lower dose (under 10 mg), 22 received a placebo (a dummy treatment with no active ingredient), and 3 received adalimumab (a different medicine used for comparison). The trial was primarily measuring how often participants developed serious blood-related conditions called lymphoproliferative disorders or lymphoma, as well as how often they experienced serious infections. It also tracked participants' ability to carry out everyday activities using a standard questionnaire. The reported data shows that for the two most serious conditions being tracked — lymphoproliferative disorders and lymphoma — no numerical results were reported for any of the four groups; the data is listed as "not available" in the submitted results. For serious infections, the reported rate was zero events per 100 person-years in the higher-dose CP-690,550 group, the placebo group, and the adalimumab group. In the lower-dose CP-690,550 group, the reported rate was approximately 0.61 serious infections per 100 person-years. Regarding everyday physical function (scored on a scale from 0, meaning no difficulty, to 3, meaning extreme difficulty), all groups started with scores roughly between 1.1 and 1.6 at the beginning of the study. The reported data shows scores generally shifted during the trial across all groups, though the adalimumab group was very small (only 3 participants started and none completed the study), so those figures should be interpreted with particular caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00650078 · results posted 13 December 2012

    According to the results reported on ClinicalTrials.gov, this trial involved 350 people in total — 231 in the NP01 group and 119 in the placebo (dummy treatment) group. The trial was measuring responses in people with rheumatoid arthritis over 12 weeks. The main thing being measured was whether participants met a standard set of improvement targets — known as an "ACR 20 response" — which required at least a 20% reduction in the number of tender joints, swollen joints, and at least three out of five other measures of disease activity reported by patients and doctors. A secondary measure looked at changes in morning stiffness — how long participants felt stiff after waking up. The reported data shows that at the 12-week mark, 108 out of 231 participants in the NP01 group met the ACR 20 response criteria, compared with 34 out of 119 in the placebo group. For morning stiffness, the reported data shows an average reduction of around 55% from the starting point in the NP01 group, compared with around 35% in the placebo group. These figures represent what was recorded and reported — they do not on their own tell us whether any difference between groups was meaningful or due to chance. It is also worth noting that 14 people in the NP01 group and 13 in the placebo group did not complete the trial, though the reasons for this were not detailed in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01059864 · results posted 13 December 2012

    According to the results reported on ClinicalTrials.gov, this trial enrolled 111 people in an initial open-label phase (where everyone received the same study drug, CP-690,550, also known as tofacitinib). Of those, 98 completed that phase and went on to a second, double-blind phase (where neither participants nor researchers knew who was receiving which treatment). In that second phase, 50 participants were assigned to receive CP-690,550 combined with atorvastatin (a cholesterol-lowering medicine), and 48 were assigned to receive CP-690,550 combined with a placebo (an inactive dummy pill). The trial was primarily measuring changes in LDL cholesterol — often called "bad cholesterol" — levels over a six-week treatment period. The reported data shows that the main result — the percentage change in LDL cholesterol from the start of the double-blind phase to week 12 — differed notably between the two groups. Participants in the CP-690,550 plus atorvastatin group showed an average decrease of around 35%, while those in the CP-690,550 plus placebo group showed an average increase of around 6%. In actual cholesterol units (mg/dL), the reported data shows the atorvastatin group's LDL levels fell by an average of approximately 51.5 mg/dL, whereas the placebo group's levels rose by an average of approximately 5.3 mg/dL. A range of additional measurements — including other cholesterol types, particle sizes, and related blood fats — were also recorded as secondary outcomes, with various figures reported for each group, though the data as submitted does not include full labels for every individual sub-measurement reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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  • NCT00396812 · results posted 14 November 2012

    According to the results reported on ClinicalTrials.gov, this trial (NCT00396812) involved just four people, all of whom received the study drug rituximab. Three participants completed the trial, while one did not finish. The trial was measuring changes in rheumatoid arthritis-related signs and symptoms over 48 weeks (roughly one year), looking at things like joint tenderness, joint swelling, pain levels, and overall assessments of disease activity from both the patient's and doctor's perspectives. The reported data shows the following changes from the start of the trial to week 48. On the DAS28-ESR — a combined disease activity score running from 0 to 10, where a lower number means less disease activity — the average score fell by 1.5 points. For swollen joints (measured across 28 joints, where lower is better), the average count fell by 4.7 joints. For tender joints across the same 28 joints, the average count increased by 1.3 joints. On a 0–100 pain scale (where 0 is no pain and 100 is the worst pain), participants' self-reported pain fell by an average of 2.3 points. Participants' own rating of their overall disease activity fell by 1.2 points on the same 0–100 scale, and the doctors' rating of each patient's disease activity fell by an average of 2.4 points on that same scale. It is important to note that this was an extremely small trial with only four participants, so the reported numbers describe a very limited group of people only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00889863 · results posted 16 October 2012

    According to the results reported on ClinicalTrials.gov, this trial (NCT00889863) tested a medicine called canakinumab in children and young people with a condition called systemic juvenile idiopathic arthritis (a type of childhood joint disease). The trial had two main parts. In Part I, 177 participants started on canakinumab in an open-label phase (meaning everyone knew what they were receiving). In Part II, 100 participants who had responded in Part I were then randomly split — 50 continued on canakinumab and 50 were switched to a placebo (a dummy treatment with no active ingredient) in a blinded phase (meaning neither the participants nor the researchers knew who was receiving which). The reported data shows the following for Part I: among participants who were taking steroid medicines when they joined the study, approximately 44.5% were recorded as having been able to reduce their steroid dose according to the protocol's tapering rules, while also meeting a minimum level of disease response. Of those on steroids at the start of one particular phase (Part Ic), about 62% met the steroid-reduction criteria by the end of that phase. Approximately 32.8% of those on steroids at study entry reached a very low steroid dose (≤0.2 mg/kg) by the end of that phase. Looking at broader disease response measures, the reported data shows that 77.1% of participants met what is called an "ACR30" level of response (roughly a 30% improvement across several disease measures) by the end of Part I, with 73.1% at ACR50, 64.6% at ACR70, 51.4% at ACR90, and 34.3% meeting full ACR100 criteria. The reported median time to first reaching an ACR50 response alongside a normalised inflammation marker was approximately 20.4 days. For Part II, the reported data shows that in the placebo group, the estimated median time before a disease "flare" (a return or worsening of symptoms) was 236 days. For the canakinumab group, this median figure was recorded as "NA" (not reached), meaning that based on the data collected, more than half of participants in that group had not experienced a flare by the time the study period ended — so a precise median number of days could not be calculated. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00361335 · results posted 24 August 2012

    According to the results reported on ClinicalTrials.gov, this trial looked at golimumab — a medicine used in rheumatoid arthritis — given through a drip into a vein (intravenously). Participants were split into five main groups: some received golimumab at a lower dose (2 mg/kg) combined with another medicine called methotrexate (MTX), some received golimumab alone at either dose level (2 mg/kg or 4 mg/kg), some received the higher golimumab dose (4 mg/kg) with MTX, and some received an inactive (placebo) drip with MTX. Around 129 people started in each of the five original groups, making roughly 643 participants in total at the beginning. The trial measured how many people showed meaningful improvements in joint swelling, joint tenderness, pain, and other disease markers at certain points in time. The reported data shows that the main thing being measured — called an ACR 50 response at week 14 — counted how many people had at least a 50% improvement across several joint and symptom measures. At week 14, the numbers of participants reaching this level of improvement were: 28 out of 129 in the lower-dose golimumab-plus-MTX group, 16 out of 128 in the lower-dose golimumab-alone group, 27 out of 128 in the higher-dose golimumab-plus-MTX group, 25 out of 129 in the higher-dose golimumab-alone group, and 17 out of 129 in the placebo-plus-MTX group. For secondary measures, the reported data shows similar patterns at week 24, and when looking at a less strict improvement threshold (ACR 20, meaning at least 20% improvement), larger numbers of participants reached that threshold across all groups. A separate score measuring overall disease activity (on a scale of 0 to 10) also showed that more participants in the golimumab groups reached a moderate or good response compared to the placebo group. A quality-of-life physical score (on a scale of 0 to 100, where higher is better) showed small increases from baseline across all groups, with figures ranging from about 4 to 7 points improvement reported across the different groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00791921 · results posted 6 August 2012

    According to the results reported on ClinicalTrials.gov, this trial (NCT00791921) enrolled 230 people with rheumatoid arthritis — 116 received a medicine called CDP870 (200mg) and 114 received a placebo (a dummy treatment with no active ingredient). The trial was measuring how many participants showed a meaningful improvement in their arthritis symptoms, using a standard checklist called the ACR20. This checklist looks at things like the number of painful or swollen joints, physical function, pain levels, and assessments from both the patient and their doctor — a person "passes" the ACR20 if they show at least 20% improvement across most of these areas. By the end of the study, 82 people in the CDP870 group had completed the trial compared to only 18 in the placebo group. The reported data shows that at the 12-week mark (the main measurement point), 67.2% of participants in the CDP870 group met the ACR20 improvement threshold, compared to 14.9% in the placebo group. For the secondary measurement at 24 weeks, the reported figures were 63.8% in the CDP870 group and 11.4% in the placebo group. These numbers simply describe how many people in each group reached that 20% improvement mark at each time point — they do not tell us about individual experiences or what might happen in any other situation. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00195650 · results posted 31 July 2012

    According to the results reported on ClinicalTrials.gov, this trial enrolled 846 people, all of whom received the medication adalimumab. It was a long-term continuation study, meaning participants had already taken part in an earlier trial and continued treatment here. The trial ran for up to 520 weeks (roughly 10 years) and was measuring how many participants reached certain pre-defined levels of improvement in their joint symptoms — specifically in things like tender and swollen joint counts, pain scores, and a laboratory marker of inflammation. Of the 846 who started, 321 completed the study and 525 did not complete it (the reasons were not detailed in the data provided here). The reported data shows that at the halfway point (week 260, roughly 5 years in), 402 out of 846 participants met the threshold for a 20% improvement in symptoms (called ACR20), 279 met the threshold for a 50% improvement (ACR50), and the number meeting the 70% improvement threshold (ACR70) at week 260 was not reported in the data. By week 520 (roughly 10 years), the reported numbers were 187 participants meeting the 20% improvement threshold, 132 meeting the 50% threshold, and 78 meeting the 70% improvement threshold. As a secondary measure, the reported data shows that 808 out of 846 participants experienced at least one adverse event (that is, any unwanted or unexpected medical occurrence) during the course of the study — further details on those events were noted as available in a separate section of the trial record. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00160693 · results posted 9 July 2012

    According to the results reported on ClinicalTrials.gov, this trial followed 402 people with rheumatoid arthritis who received the drug certolizumab pegol. Participants came from two earlier related studies and continued into this long-term follow-up, which ran for up to 8 years. Of the 402 who started, 167 completed the study and 235 did not finish, though the reasons for not completing were not detailed in the data provided here. The trial was tracking two main things: how many participants experienced any unwanted medical event (called an adverse event) over the 8 years, and how many stopped taking the drug because of such an event. It also tracked how many participants showed a meaningful improvement in their joint symptoms at several points in time over roughly four years. The reported data shows that 93.5% of participants experienced at least one adverse event at some point during the 8-year study period, and 24.9% withdrew from the study due to an adverse event. It is important to note that an adverse event, as defined in the study, does not necessarily mean the event was caused by the drug — it refers to any unwanted medical occurrence that happened during the study. For the symptom improvement measurements, the trial used a standard rheumatology scoring system (ACR20), which counts someone as a "responder" if their tender joints, swollen joints, and several other measures each improved by at least 20% compared to where they started. The reported data shows that among those still being assessed at each point, 58.1% met this threshold at Week 52 (about one year), 60.0% at Week 100 (about two years), 68.4% at Week 160 (about three years), and 72.6% at Week 208 (about four years). It is worth keeping in mind that because many participants left the study before its end, the numbers at later time points reflect a smaller and potentially different group than those who started. These percentages describe only the people still being measured at each stage, and the data does not break down why participants left. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00753454 · results posted 14 June 2012

    According to the results reported on ClinicalTrials.gov, this trial enrolled 168 people, all of whom received the study drug CDP870 (also known as certolizumab pegol), which is a treatment being investigated for rheumatoid arthritis. Of the 168 who started, 154 completed the study and 14 did not. The trial was primarily focused on tracking unwanted medical events (called adverse events) that occurred during the study period — specifically how many participants experienced them, how many left the study because of them, and how many experienced a serious adverse event. The reported data shows that 52.4% of participants (roughly just over half) experienced at least one adverse event during the study period. Around 2.4% of participants withdrew from the study due to an adverse event, and 3.0% experienced what was classified as a serious adverse event — meaning something that resulted in hospitalisation, was life-threatening, or caused significant disability, among other criteria. The trial also measured rheumatoid arthritis symptoms using standard scoring tools (ACR20, ACR50, and ACR70), which rate whether a participant's joint tenderness, swelling, and other measures improved by at least 20%, 50%, or 70% respectively from where they started. The reported data shows that 73.5% of participants met the ACR20 threshold, 59.4% met the ACR50 threshold, and 39.4% met the ACR70 threshold at the end of the study or at the time they withdrew. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00162266 · results posted 1 June 2012

    According to the results reported on ClinicalTrials.gov, this trial involved people with rheumatoid arthritis who had not responded well enough to the drug methotrexate alone. During the main double-blind phase (where neither doctors nor participants knew who was receiving which treatment), 115 people received a higher dose of abatacept (10 mg/kg) plus methotrexate, 105 received a lower dose of abatacept (2 mg/kg) plus methotrexate, and 119 received a placebo (inactive treatment) plus methotrexate. After this phase, 219 participants moved into an open-label period where everyone received the higher dose of abatacept. The trial was measuring how many participants showed at least a 20% improvement in joint swelling, tenderness, and several other disease markers — a standard benchmark known as an "ACR 20 response." The reported data shows that at day 180 (the end of the main double-blind phase), 70 out of 115 participants in the higher-dose abatacept group met the ACR 20 response benchmark, compared with 44 out of 105 in the lower-dose abatacept group and 42 out of 119 in the placebo group. For higher levels of improvement — a 50% improvement benchmark (ACR 50) — the reported numbers at the final double-blind timepoint were 28 participants in the higher-dose group, 18 in the lower-dose group, and 15 in the placebo group. For a 70% improvement benchmark (ACR 70), the reported numbers at that same timepoint were 10, 5, and 1 respectively. A separate score tracking the overall degree of change across all measures (called ACR-N, where higher numbers mean greater improvement and negative numbers mean worsening) was also tracked over time; the reported data shows this score rose across all three groups over the course of the double-blind period, with the higher-dose abatacept group recording the highest values at each timepoint. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00655824 · results posted 18 April 2012

    According to the results reported on ClinicalTrials.gov, this trial enrolled 92 people, all of whom received a 700 mg intravenous (drip) infusion of a medicine called ofatumumab. The trial was designed to study long-term treatment in people with rheumatoid arthritis — a condition causing joint pain and inflammation. However, the reported data shows that the sponsor chose to stop the intravenous version of this treatment program early, meaning only 8 of the 92 participants completed the study, and 84 did not. Because the study ended early, the main thing it set out to measure — how long people stayed on treatment before stopping — was never formally assessed. Likewise, a measure of how many participants achieved a 20% improvement in their symptoms (known as ACR20) was also not evaluated. The reported data shows that several secondary (additional) measurements were collected during the study. One of these was a disease activity score called DAS28, which combines information about joint tenderness, joint swelling, a blood marker of inflammation, and the participant's own rating of their condition — higher scores mean more active disease. Across up to seven treatment rounds, the reported minimum reductions in this score ranged from about −0.87 to −2.16 points (using one blood marker) and −0.88 to −2.14 points (using another blood marker), meaning scores were lower — indicating less measured activity — compared to each starting point. The time between treatment rounds was also tracked, with reported averages ranging from around 120 days to about 329 days depending on the course. Blood levels of ofatumumab were measured before and after infusions across several treatment rounds; figures were reported for some rounds but were noted as not available for others. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00611455 · results posted 28 October 2011

    According to the results reported on ClinicalTrials.gov, this trial enrolled 265 adults with rheumatoid arthritis — 134 received a placebo (a dummy treatment with no active ingredient) and 131 received a medicine called ofatumumab at a dose of 700 mg. The main thing the trial was measuring was how many participants showed at least a 20% improvement in a standard rheumatoid arthritis scoring system (called the ACR score) after 24 weeks. This score takes into account things like the number of painful and swollen joints, pain ratings, and a blood marker for inflammation. After the initial 24-week phase, participants could continue into a longer open-label period (where everyone received ofatumumab) lasting up to 120 weeks, followed by a follow-up monitoring period of approximately two years. The reported data shows that at the 24-week mark, 64 out of 131 participants in the ofatumumab group reached the 20% improvement threshold, compared with 35 out of 134 in the placebo group. For a higher bar of 50% improvement at 24 weeks, the reported numbers were 35 (ofatumumab) versus 14 (placebo); and for 70% improvement, 17 (ofatumumab) versus 3 (placebo). A separate measure of disease activity — called the DAS28 score, where lower numbers indicate less active disease — was reported at 4.12 for the ofatumumab group and 4.98 for the placebo group at week 24. The reported data also shows these counts were tracked at multiple earlier time points (weeks 4, 8, 12, 16, and 20), with the numbers fluctuating across those visits in both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00234884 · results posted 30 September 2011

    According to the results reported on ClinicalTrials.gov, this trial enrolled 3,435 people with rheumatoid arthritis, all of whom received the medication adalimumab. Of those who started, 1,805 completed the study and 1,630 did not finish. The trial was measuring joint disease activity and physical function over time, using several scoring tools — including a joint disease activity score (called DAS28), improvement ratings set by a medical organisation (called ACR20, ACR50, and ACR70), and a physical function questionnaire (called HAQ-DI). The reported data shows that the average disease activity score (DAS28) started at 6.0, which is considered high disease activity, and was reported at around 2.8–3.3 across later time points — with scores below 3.2 considered low disease activity on this scale. For the improvement ratings, the reported data shows that across various time points, between roughly 76% and 88% of participants met the threshold for a 20% or more improvement in joint measures (ACR20); between about 56% and 70% met the threshold for a 50% or more improvement (ACR50); and between about 35% and 48% met the threshold for a 70% or more improvement (ACR70). The reported data shows the physical function score (HAQ-DI, where lower numbers mean less difficulty) changed by approximately −0.65 to −0.76 from the starting point across the measured time points — the study notes a change of −0.22 is considered the minimum meaningful change on this scale. It is worth noting that this trial had no comparison group, meaning all participants received adalimumab and there was no untreated or differently treated group to compare results against. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00420927 · results posted 29 September 2011

    According to the results reported on ClinicalTrials.gov, this trial involved 1,032 people with rheumatoid arthritis across two periods. In the first period, 515 participants received a combination of adalimumab (ADA) plus methotrexate (MTX), and 517 received a placebo plus methotrexate. After that first phase, participants were reassigned into five different groups for the second period, depending on how they had responded — some continued, stopped, or switched treatments. The trial was measuring two main things at around 78 weeks: how many participants had low disease activity (using a scoring system called DAS28, which combines joint counts, a blood marker, and the patient's own rating of their condition) and how many showed no meaningful worsening on joint X-rays (using a scoring system called the modified Total Sharp Score, or mTSS). The reported data shows that for the primary outcome — participants who had both low disease activity and no notable X-ray worsening at week 78 — the numbers across the five groups were: 59 participants in Arm 1 (ADA+MTX then switched to placebo+MTX), 73 in Arm 2 (ADA+MTX continued), 94 in Arm 3 (ADA+MTX then open-label ADA+MTX), 61 in Arm 4 (placebo+MTX continued), and 129 in Arm 5 (placebo+MTX then open-label ADA+MTX). For the secondary outcomes, the reported data shows similar patterns across the groups: for low disease activity alone, the numbers ranged from 71 to 185 participants across the five arms; for remission (an even lower disease activity score), the numbers ranged from 57 to 138; for no X-ray worsening alone, from 70 to 220; and for a standard measure of joint improvement called ACR20 (at least 20% improvement across several joint and symptom measures), the numbers ranged from 84 to 257 participants. It is worth noting that the groups varied considerably in size, so the raw numbers above reflect both the group sizes and the outcomes observed. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00299546 · results posted 28 September 2011

    According to the results reported on ClinicalTrials.gov, this trial enrolled 461 people with rheumatoid arthritis across three groups: 155 received a placebo (inactive treatment), 153 received a 50 mg dose of golimumab, and 153 received a 100 mg dose of golimumab. The trial was measuring whether golimumab reduced the signs and symptoms of rheumatoid arthritis compared to placebo, using a set of standard scoring tools that look at things like joint tenderness, swelling, pain, and physical function. It is worth noting that significantly fewer participants completed the study than started it — 55 in the placebo group, 61 in the 50 mg group, and 67 in the 100 mg group finished. The reported data shows that the main thing being measured was a standard rheumatology scoring tool called ACR 20 at week 14, which counts the number of participants who showed at least a 20% improvement across several joint and symptom measures. At week 14, 27 out of 155 placebo participants reached this threshold, compared with 51 out of 153 in the 50 mg golimumab group and 54 out of 153 in the 100 mg group. For a stricter version of this measure (ACR 50, meaning at least 50% improvement), the reported numbers at week 14 were 10 for placebo, 22 for the 50 mg group, and 27 for the 100 mg group. A separate disease activity score (DAS 28, a combined index rated 0–10 where lower is better) showed responses in 44 placebo participants, 82 in the 50 mg group, and 87 in the 100 mg group at week 14. The reported data also shows results at week 24. For the ACR 20 measure, 24 placebo participants, 46 in the 50 mg group, and 63 in the 100 mg group reached that threshold. A questionnaire measuring everyday physical difficulty (the HAQ, scored 0–3 where 0 means no difficulty) showed an average improvement from the starting score of 0.0 points in the placebo group, 0.125 points in the 50 mg group, and 0.25 points in the 100 mg group at week 24. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01078116 · results posted 25 July 2011

    According to the results reported on ClinicalTrials.gov, this trial (NCT01078116) enrolled 124 participants, all of whom received the medication adalimumab for rheumatoid arthritis. Of those who started, 76 completed the study and 48 did not finish. The trial was measuring two main things: the costs associated with having rheumatoid arthritis and being treated with adalimumab (both direct costs like doctor visits, hospital stays, and medications, and indirect costs like lost income due to disability), and participants' health-related quality of life, tracked at the start of the study and again at 3, 6, and 12 months. The reported data shows that direct costs (in euros) in the three months before starting treatment were reported at around €273, rising to around €1,163 at the 3-month mark, €2,663 at 6 months, and €659 at 12 months. Indirect costs (income lost due to disability) were reported as €2,692 at 3 months, €500 at 6 months, €2,649 at 9 months, and €580 at 12 months. On the quality-of-life scales, the reported scores on the EQ-5D (where higher means better health, on a scale up to 1) moved from 0.43 at the start to 0.62 at 12 months. On the HAQ (where lower means fewer difficulties with daily activities, on a scale of 0–3), scores moved from 1.33 at the start to 0.62 at 12 months. Several other quality-of-life scores using the SF-36 questionnaire (where higher is better, out of 100) also showed changes across the same time points, with one group of domains starting at around 33.5 and reaching 60.0 by 12 months, and another starting at 18.7 and reaching 51.0. The reported data also includes a figure called an ICER (Incremental Cost-Effectiveness Ratio) — a calculation that estimates how much extra money is spent to gain one additional year of full health. The reported ICER was €13,628, which the study notes is below the €50,000 threshold that some European health systems use as a reference point. It is important to note this trial only had one group (all participants received adalimumab), so these figures reflect changes observed within that single group over time, not a comparison against a separate untreated group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00559585 · results posted 6 July 2011

    According to the results reported on ClinicalTrials.gov, this trial involved 736 people who received a under-the-skin (subcutaneous) injection form of a medicine called abatacept, and 721 people who received the same medicine through a drip into a vein (intravenous). The trial was comparing these two ways of delivering the medicine in people with rheumatoid arthritis. There was an initial double-blind phase (where neither participants nor doctors knew which method each person was receiving) lasting about 24 weeks, followed by a longer open-label phase where everyone received the under-the-skin version. The reported data shows that the main thing the trial measured was how many people reached what is called an "ACR 20 response" by around day 169 — meaning their tender and swollen joint counts, plus several other measures of disease activity, had improved by at least 20% compared to the start. According to the results reported on ClinicalTrials.gov, 527 out of 736 participants in the under-the-skin group and 514 out of 721 in the drip group reached this threshold. For higher levels of improvement (50% and 70%), the reported numbers were 357 and 341 participants respectively for the 50% threshold, and 183 and 170 for the 70% threshold. A physical function questionnaire (scored 0–3, where higher means more difficulty) showed average starting scores of 1.72 and 1.67, and average reductions of 0.69 and 0.70 points by day 169, for the two groups respectively. The reported data also shows that during the double-blind period, 493 participants in the under-the-skin group and 470 in the drip group experienced at least one adverse event (an unwanted medical occurrence during the study). Serious adverse events were reported for 31 and 35 participants respectively, and deaths during the study period were reported for 2 participants in the under-the-skin group and 5 in the drip group. These numbers are as the trial recorded and reported them; no conclusions about cause should be drawn from this summary alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00450658 · results posted 21 June 2011

    According to the results reported on ClinicalTrials.gov, this trial enrolled 415 people in the HZT-501 group and 212 people in the ibuprofen-only group. HZT-501 is a tablet that combines ibuprofen (a common pain reliever) with famotidine (a stomach-acid reducer), and the trial ran for 24 weeks. The main thing researchers were measuring was how many people in each group developed ulcers in their upper digestive tract — that is, sores in the stomach or the first part of the small intestine — detected by a camera examination called an endoscopy. Of those who started, 272 in the HZT-501 group and 122 in the ibuprofen group completed all scheduled assessments through to the end of the 24 weeks. The reported data shows that, looking at the primary measure, 40 participants in the HZT-501 group and 38 participants in the ibuprofen-only group developed an upper digestive tract ulcer at some point during the 24 weeks. For the secondary measures, the reported data shows that stomach ulcers specifically were found in 37 people taking HZT-501 and 34 people taking ibuprofen alone. Ulcers in the duodenum (the upper part of the small intestine) were recorded in 3 people in the HZT-501 group and 9 people in the ibuprofen group. The trial also tracked serious digestive complications such as bleeding or perforation — the reported data shows that zero participants in either group experienced one of these events during the study period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00106535 · results posted 7 June 2011

    According to the results reported on ClinicalTrials.gov, this trial enrolled 1,196 adults across three groups during the main two-year phase: approximately 394 received a placebo plus methotrexate, 401 received a lower dose of tocilizumab (4 mg/kg) plus methotrexate, and 401 received a higher dose of tocilizumab (8 mg/kg) plus methotrexate. A further long-term extension phase (years three to five) followed 894 participants who had received tocilizumab in some form. The trial was measuring how many participants showed meaningful improvements in rheumatoid arthritis symptoms — including joint tenderness, joint swelling, pain, and general disease activity — using a set of standardised scoring tools. The reported data shows that for the main result (the "ACR20" measure — meaning at least a 20% improvement across several symptom scores), 27% of those in the placebo-plus-methotrexate group reached this level, compared with around 51% in the lower-dose tocilizumab group and 56% in the higher-dose tocilizumab group. For a higher bar of at least 50% improvement (ACR50), the reported figures were approximately 10% for the placebo group, 25% for the lower dose, and 32% for the higher dose. For the highest bar of at least 70% improvement (ACR70), the figures were around 2% for placebo, 11% for the lower dose, and 13% for the higher dose. The reported data also shows changes in specific joint counts and patient-rated scores at 24 weeks. For swollen joints, the average reduction was about 3 joints in the placebo group, 8 in the lower-dose group, and 9 in the higher-dose group. For tender joints, the average reductions were approximately 5, 12, and 14 joints respectively. On a patient-rated disease activity scale of 0–100 (where lower is better), the average reduction from starting scores was around 18 points for the placebo group and 25 points for both tocilizumab groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01307787 · results posted 9 May 2011

    According to the results reported on ClinicalTrials.gov, this trial involved 34 people in total — 19 in a fitness program group and 15 in a waiting-list control group (who did not receive the program during the study period). The trial was designed to measure changes in cardiorespiratory fitness (how well the body uses oxygen during exercise) as its main focus, along with a range of secondary measures including muscle strength in the arms and legs, self-confidence in managing arthritis symptoms, and self-reported physical health status. The reported data shows that, on the primary measure of cardiorespiratory fitness (recorded in units called ml/min/kg), the fitness program group showed an average change of +3.82 units, while the waiting-list group showed an average change of −0.44 units. For the secondary measures, the fitness program group showed average changes of +36.06 newtons (a unit of force) for upper-body muscle strength and +111.20 newtons for lower-body muscle strength, compared to −5.49 and +25.61 newtons respectively in the waiting-list group. On self-reported physical health (scored on a 0–10 scale where a lower score means better health), the fitness program group showed an average change of −0.68, compared to −0.14 in the waiting-list group. For self-confidence in managing pain and other symptoms, the reported changes were +0.42 (fitness group) and +0.28 (waiting-list group) on a 1–5 scale; for self-confidence around physical function, the changes were +0.29 and +0.10 respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00487825 · results posted 6 May 2011

    According to the results reported on ClinicalTrials.gov, this trial (NCT00487825) enrolled 78 people with rheumatoid arthritis. Fifty-two participants received a combination of canakinumab (given by intravenous drip) plus methotrexate (taken by mouth), while 26 received methotrexate alone. Of those who started, 46 and 21 participants respectively completed the trial. The trial was measuring whether adding canakinumab to methotrexate led to greater improvements in joint symptoms compared to methotrexate on its own, using a standard rheumatology scoring system called ACR50 — which counts someone as improved if their tender and swollen joint counts, pain scores, and certain other measures all dropped by at least 50%. The reported data shows that for the primary measure (ACR50), the numbers of participants recorded as meeting that threshold were reported across what appear to be multiple time points, though the specific time points were not labelled in the submitted data. The figures reported for the combination group versus the methotrexate-alone group were: 10 vs 5, then 19 vs 9, then 24 vs 11 participants. For the secondary ACR measures (at least 20% improvement), the reported numbers were 32 vs 13, 38 vs 16, and 39 vs 20 participants respectively across those same unlabelled time points. For the highest threshold (ACR90, at least 90% improvement), the reported figures were 1 vs 3, 6 vs 3, and 17 vs 9 participants. At 26 weeks, the reported data shows 46.2% of the combination group and 30.8% of the methotrexate-alone group were recorded as having a "good" response on a separate disease activity scoring system (EULAR/DAS28). The number of participants recorded as being in clinical remission by the end of the study was reported as 20 (combination group) and 6 (methotrexate-alone group). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00048932 · results posted 3 May 2011

    According to the results reported on ClinicalTrials.gov, this trial (NCT00048932) involved people with active rheumatoid arthritis (a condition where the immune system attacks the joints). During the main double-blind period — where neither participants nor their doctors knew who received which treatment — 959 people received the study drug abatacept and 482 received a placebo (a dummy treatment with no active ingredient). After that phase ended, 1,184 participants moved into an open-label period where everyone received abatacept. The trial was primarily measuring the types and numbers of unwanted medical events (called adverse events) that occurred, as well as changes in blood test results, to understand what happened to participants over the course of the study. The reported data shows that during the double-blind period, deaths occurred in 5 people in the abatacept group and 4 in the placebo group. Serious adverse events (unexpected medical problems serious enough to require hospitalisation or that were life-threatening, among other criteria) were recorded in 123 abatacept participants and 59 placebo participants. Adverse events of any kind were reported in 866 people taking abatacept and 417 taking placebo. The reported data also shows that notable changes in blood test results — such as significant shifts in blood cell counts or liver-related markers — were recorded in small numbers of participants across both groups, with figures ranging from zero to a few dozen depending on the specific measurement. No clinically significant physical examination or vital signs abnormalities were reported in either group. Regarding immune reactions to the study drug itself, 22 out of all treated participants tested positive for antibodies against abatacept or a related protein. It is important to note that because roughly twice as many people were in the abatacept group as the placebo group, simple comparisons of raw numbers between the two groups need to take that difference in group size into account — the reported data does not include any adjusted figures for this summary. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00690573 · results posted 1 April 2011

    According to the results reported on ClinicalTrials.gov, this trial involved 25 children with juvenile rheumatoid arthritis (a form of arthritis that affects children) who received the medication adalimumab. The trial was measuring how many participants showed a meaningful improvement in their arthritis symptoms over time, using a standard set of six measures including things like how many joints were affected, how well the child could move and function, and assessments from both the doctor and the parent or patient. Of the 25 children who started, 16 completed the study and 9 did not finish. The reported data shows that at 16 weeks — the main point being measured — 23 out of 25 participants met the threshold for a "PedACR30" response, meaning they showed at least 30% improvement across the required number of measures compared to when they started. For the higher thresholds (meaning greater degrees of improvement), the reported data shows 22 out of 25 participants met the 50% improvement threshold (PedACR50), and 15 out of 25 met the 70% improvement threshold (PedACR70) at week 16. The trial also tracked levels of the medication in participants' blood at multiple points across the study, with reported concentrations ranging from approximately 5.03 to 11.4 micrograms per millilitre (a measure of how much of the drug was present in the bloodstream). Regarding antibodies — proteins the body can sometimes produce in response to a medication — the reported data shows that 4 participants tested positive for anti-adalimumab antibodies at one recorded time point, and 6 at another. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00764673 · results posted 2 March 2011

    According to the results reported on ClinicalTrials.gov, this trial involved 71 people who received a knee replacement implant called the Primary 3DKnee. All participants had the same implant, so there was no comparison group. The trial was measuring how well the knee performed after surgery using standard scoring tools, as well as looking at X-ray images to check whether the implant had shifted or loosened, and recording any device-related problems over a two-year period. Of the 71 people who started, 59 completed the study, and 12 did not complete it. The reported data shows that on the Knee Society Knee Rating Score — a 100-point scale where higher scores reflect less pain, better stability, and greater movement — the average score across participants was 82.9, which falls in the "Good" range (80–90) according to the scoring system used. On the Knee Society Function Score — which looks at how far a person can walk and whether they can manage stairs, out of 100 points — the average reported was 76.6. The Oxford Knee Score, a questionnaire filled in by patients themselves rated out of 48, returned an average of 36.3, which the scale's categories describe as falling in the "mild to moderate knee arthritis" range. The reported data also shows that zero participants showed X-ray signs of the implant loosening or shifting beyond the defined thresholds. For the safety measure, the data lists three separate figures (2, 18, and 40 events), but the breakdown of what each number refers to was not clearly distinguished in the submitted data, so a plain description of each figure cannot be provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00547521 · results posted 24 January 2011

    According to the results reported on ClinicalTrials.gov, this trial looked at a medication called abatacept, given by injection under the skin (subcutaneous), in people with rheumatoid arthritis. A total of 100 people took part in the main four-month study — 51 in a group receiving abatacept together with another medicine called methotrexate, and 49 in a group receiving abatacept on its own. A separate longer-term follow-up phase then enrolled 90 participants. The main thing the trial was measuring was whether participants developed antibodies against the abatacept medication itself — in other words, whether the body's immune system started to recognise and react to the drug. The trial also tracked a disease activity score called DAS28-CRP, which is a combined measure of joint tenderness, joint swelling, a blood inflammation marker, and the participant's own rating of their condition, all rolled into a single number. The reported data shows that, when tested using the standard laboratory method (ELISA) at the end of the four-month study, zero participants in either group were found to have developed detectable antibodies against abatacept. When a more sensitive laboratory method (ECL/MSD) was used across the same period, only one participant in the combination group showed a positive antibody result at any point, while zero in the monotherapy group did across most time points. For the disease activity score, the reported data shows an average decrease (improvement) of 1.67 points in the combination group and 1.94 points in the monotherapy group from their starting scores to the end of the four months. For two of the primary outcome measures relating to antibody responses in subgroups, no numerical data was reported on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00095147 · results posted 21 January 2011

    According to the results reported on ClinicalTrials.gov, this trial enrolled 431 adults across three treatment groups during its initial double-blind phase: 156 people received abatacept (a medicine sometimes called ABA) combined with methotrexate, 165 received infliximab (INF) combined with methotrexate, and 110 received a placebo (inactive treatment) combined with methotrexate. The trial was measuring changes in rheumatoid arthritis disease activity using a scoring tool called the DAS28 — a number calculated from joint counts, a blood marker of inflammation, and the participant's own rating of how their condition felt. A lower DAS28 score indicates lower disease activity. After the double-blind phase ended, most participants moved into a longer-term open-label period, with 372 people taking part in that stage. The reported data shows that the primary result — the change in DAS28 score from the start of the trial to around six months (Day 197) — was a decrease of 2.53 points in the abatacept-plus-methotrexate group, compared with a decrease of 1.48 points in the placebo-plus-methotrexate group. For the infliximab-plus-methotrexate group, the reported decrease was 2.25 points compared with the same placebo group's 1.48 points. The trial also measured a secondary score comparing abatacept and infliximab's disease activity across the full 12 months using a cumulative calculation; the reported figures were 1,638.6 for abatacept and 1,657.5 for infliximab, though the data does not include context to interpret what those numbers mean in isolation. Regarding everyday physical functioning (measured by a questionnaire called the HAQ-DI, where lower scores indicate less difficulty), the reported data shows that at Day 197, approximately 61.5% of abatacept participants, 58.8% of infliximab participants, and 40.9% of placebo participants showed a clinically meaningful improvement in their physical function score. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00520572 · results posted 4 October 2010

    According to the results reported on ClinicalTrials.gov, this trial enrolled 385 adults with rheumatoid arthritis across six groups. Participants were randomly assigned to receive one of four doses of an investigational medicine called AZD9056 (50 mg, 100 mg, 200 mg, or 400 mg daily), a placebo (a dummy treatment with no active ingredient), or an existing medicine called etanercept, which was included as a comparison. The trial ran for six months and was primarily measuring how many people in each group achieved at least a 20% improvement on a standard rheumatoid arthritis symptom score — a combined measure that takes into account things like joint swelling, joint tenderness, pain, and physical function. The reported data shows that for the main outcome (at least 20% symptom improvement at six months), the numbers of participants who reached that level were: 23 out of 64 in the 50 mg AZD9056 group, 26 out of 64 in the 100 mg group, 23 out of 64 in the 200 mg group, 21 out of 64 in the 400 mg group, 21 out of 65 in the placebo group, and 42 out of 64 in the etanercept group. For the secondary outcomes — which looked at higher levels of improvement (50% and 70%) — the reported numbers followed a similar pattern across the groups, with the etanercept group again recording the highest counts (30 and 15 participants respectively). Two further secondary measures looked at changes in standardised symptom scores. The reported data shows that all AZD9056 dose groups and the placebo group had score changes ranging from around −1.0 to −1.4 on one scale and around −0.2 to −0.3 on a physical function scale, while the etanercept group recorded changes of −2.3 and −0.6 on those same scales. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00122382 · results posted 13 July 2010

    According to the results reported on ClinicalTrials.gov, this trial enrolled 511 people across two groups during the main double-blind phase: 256 people received a medicine called abatacept combined with methotrexate, and 255 received a dummy (placebo) treatment combined with methotrexate. Neither the participants nor the researchers knew who was in which group during this phase. A further open-label phase (where everyone knew what treatment was being given) involved 459 participants all receiving abatacept with methotrexate. The trial was measuring how rheumatoid arthritis symptoms, physical function, quality of life, and joint damage changed over 12 months. The reported data shows a number of outcomes at the 12-month mark. On a standard measure of joint tenderness and swelling improvement of at least 50% (called ACR 50), 147 people in the abatacept-plus-methotrexate group met that threshold compared with 107 in the placebo-plus-methotrexate group. For a more demanding measure — at least 70% improvement sustained over six consecutive months — 70 people in the abatacept group met that bar compared with 30 in the placebo group. On a disease-activity scoring scale (ranging from 0 to 10, where higher means more active disease), both groups showed a reduction from their starting scores: the abatacept group's score dropped by an average of 3.22 points, while the placebo group's dropped by 2.49 points. For physical function (measured by a questionnaire scored 0–3, where lower is better), 184 people in the abatacept group and 157 in the placebo group reported a meaningful improvement. On quality-of-life scores and X-ray measures of joint damage, the reported data shows small numerical differences between the two groups, but specific figures for some sub-measures were reported across multiple categories in the data without a clear single summary figure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00418717 · results posted 4 May 2010

    According to the results reported on ClinicalTrials.gov, this trial enrolled 42 people with rheumatoid arthritis and tested a medicine called etanercept given in two different ways, one after the other. First, for four weeks, participants received a 25 mg dose twice a week (Treatment Period A). Then, for the following eight weeks, the same participants switched to a 50 mg dose once a week (Treatment Period B). The trial was measuring disease activity and how the drug moved through the body under each dosing approach. Of the 42 people who started, 39 completed the full study. The reported data shows that disease activity was measured using a scoring system called DAS28-4ESR, which runs from 0 to 10 — lower numbers suggest the disease is better controlled, with scores of 3.2 or below considered well controlled and scores of 5.1 or above considered active disease. At the end of the twice-weekly dosing period, the reported average score was 3.26, and at the end of the once-weekly dosing period it was 3.13. The trial also measured how much of the drug was present in the blood over time (a measure called AUC, or "area under the curve" — essentially a way of tracking the total drug exposure across a set period). The reported data shows an AUC of 19.67 µg·day/mL for the twice-weekly period and 17.92 µg·day/mL for the once-weekly period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00195702 · results posted 1 March 2010

    According to the results reported on ClinicalTrials.gov, this trial enrolled 619 participants across three groups during the double-blind phase: 212 received adalimumab 20 mg every week, 207 received adalimumab 40 mg every other week, and 200 received a placebo (an inactive treatment). The trial was measuring joint symptoms, physical disability, and joint damage in people with rheumatoid arthritis over 52 weeks. Those who completed the double-blind phase were able to continue into an open-label extension, where all participants received adalimumab 40 mg every other week. The reported data shows that at week 24, 129 out of 212 participants in the 20 mg every-week group, 131 out of 207 in the 40 mg every-other-week group, and 59 out of 200 in the placebo group met a standard set of criteria for a meaningful reduction in joint tenderness, swelling, and other disease measures (known as an ACR20 response). Similar patterns were reported at week 52. For joint damage — measured using X-ray scores on a scale where higher numbers mean more damage — the reported change from the starting point was +0.8 for the 20 mg group, +0.1 for the 40 mg group, and +2.7 for the placebo group at week 52. For day-to-day physical ability, scored on a questionnaire where a more negative number suggests less difficulty with daily tasks, the reported changes at week 52 were -0.61 (20 mg group), -0.59 (40 mg group), and -0.25 (placebo group). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00195663 · results posted 25 February 2010

    According to the results reported on ClinicalTrials.gov, this trial enrolled 799 people with rheumatoid arthritis across three groups: 257 received methotrexate alone, 274 received adalimumab alone, and 268 received adalimumab combined with methotrexate. The trial ran for two years (the main blinded phase) followed by an open-label extension period where participants knew what treatment they were receiving. The trial was measuring things like joint tenderness and swelling, physical function, joint damage visible on X-rays, and whether participants reached a state of low disease activity called "clinical remission." The reported data shows the following for the main one-year (Week 52) results. For the primary measure of meaningful symptom improvement (called ACR50 — meaning at least 50% improvement in tender joints, swollen joints, and several other disease markers), 118 out of 257 participants in the methotrexate group, 113 out of 274 in the adalimumab group, and 165 out of 268 in the combination group met this threshold. For joint damage on X-rays (scored on a scale where higher numbers mean more damage), the average increase from the start of the trial was 5.7 points for methotrexate, 3.0 for adalimumab, and 1.3 for the combination group. On a physical function questionnaire (scored 0–3, where lower is better), the average change from baseline was −0.8 for both the methotrexate and adalimumab groups, and −1.1 for the combination group. Regarding clinical remission at Week 52, 53 participants in the methotrexate group, 64 in the adalimumab group, and 115 in the combination group met the remission threshold. The reported data for the two-year (Week 104) results shows similar patterns. For symptom improvement (ACR50), 110 out of 257, 101 out of 274, and 158 out of 268 participants met the threshold in the methotrexate, adalimumab, and combination groups respectively — noting that anyone who left the trial early was counted as not having responded. For joint damage on X-ray, the average increase over two years was 10.4 points for methotrexate, 5.5 for adalimumab, and 1.9 for the combination group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00724243 · results posted 19 February 2010

    According to the results reported on ClinicalTrials.gov, this trial enrolled 33 people, all of whom received a medicine called infliximab. The trial was looking at how a measure of joint inflammation and disease activity — called the DAS28 score — changed over time. The DAS28 is a combined score ranging from 0 to 10, where lower numbers indicate less disease activity. Eighteen of the 33 participants completed the study, while 15 did not finish. The reported data shows that, on average, participants began the study with a DAS28 score of 7.11, which is considered a high level of disease activity. By the end of the treatment period, the reported average score was 2.94, representing an average change of 3.27 points on the scale. Regarding the second primary measure, the reported data shows that 27 out of 33 participants met the criteria for either a "good" or "moderate" response according to a standard European rheumatology rating system (EULAR), while 19 participants were specifically classified as having a "good" response — meaning their score improved by more than 1.2 points and their final score was 2.4 or below. It is worth noting that the data does not include a comparison group of people who did not receive infliximab, which limits what can be concluded from these numbers alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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  • NCT00427934 · results posted 5 February 2010

    According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called maraviroc in people with rheumatoid arthritis. The trial had two parts: a smaller pharmacokinetics (PK) section — which measured how the body processes the drug — involving 8 participants on a lower dose and 8 on a higher dose; and a larger proof-of-concept (POC) section, where 78 people were assigned to maraviroc 300 mg twice daily and 34 to a placebo (a dummy treatment with no active ingredient). In total, 128 people started the trial. Not everyone finished — 55 of the 77 treated maraviroc POC participants and 19 of the 33 treated placebo participants completed the study. The reported data shows that the trial measured joint symptoms using standard rheumatoid arthritis scoring systems. One measure looked at how many participants met the "ACR 20" threshold — meaning at least a 20% improvement in tender and swollen joint counts plus several other assessments. At week 8, 23 people in the maraviroc group and 7 in the placebo group met this threshold. At week 12, 8 people in the maraviroc group and 3 in the placebo group met the stricter "ACR 50" threshold (50% improvement). For the even stricter "ACR 70" threshold (70% improvement), the numbers were very small across both groups at all time points — ranging from 0 to 2 participants. The reported data also shows changes in the number of tender and swollen joints over time. For example, by week 12, the average number of tender joints had decreased by about 4.9 in the maraviroc group and 3.4 in the placebo group, while swollen joints decreased by about 3.5 and 3.4 respectively. Self-reported pain scores (on a 0–100 scale) also showed reductions in both groups across the study period, with figures not reported for a primary outcome measure in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00409838 · results posted 26 January 2010

    According to the results reported on ClinicalTrials.gov, this trial enrolled 56 people in the abatacept (10 mg/kg) group and 57 people in the placebo group for the initial short-term phase, lasting approximately six months. All participants had rheumatoid arthritis. After the short-term phase ended, 105 participants (from both original groups) entered a longer-term extension period where everyone received abatacept; 87 of those 105 completed that stage. The trial's main goal was to measure how many participants reached a level of improvement in their arthritis symptoms — including joint tenderness, swelling, pain, and physical function — that met a standard benchmark called ACR20, which represents at least a 20% improvement across several measures. The reported data shows that at the end of the short-term period, 65.5% of participants in the abatacept group and 42.1% in the placebo group met the ACR20 improvement benchmark. For higher levels of improvement (ACR50, meaning at least 50% improvement), the reported figures were 32.7% for abatacept and 15.8% for placebo; for ACR70 (at least 70% improvement), the figures were 14.5% and 7.0% respectively. On a disease activity score (rated 0–10, where higher means more active disease), the abatacept group showed an average reduction of about 2.12–2.22 points, compared with about 1.15–1.21 points in the placebo group. A questionnaire measuring everyday physical functioning (scored 0–3, where lower means less difficulty) showed an average reduction of approximately 0.53 points in the abatacept group versus 0.24 in the placebo group. A general quality-of-life questionnaire (scored 0–100, where higher means better quality of life) showed improvements of roughly 6.5 to 8.2 points for abatacept and 2.2 to 4.4 points for placebo across its physical and mental components. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00761514 · results posted 19 November 2009

    According to the results reported on ClinicalTrials.gov, this trial involved 14 adults with rheumatoid arthritis who all received the same treatment — an injection called adalimumab (40 mg given every second week). The trial ran for 24 weeks and was measuring two main things: how much participants' everyday functioning changed (things like sleeping, dressing, walking, and managing feelings of anxiety or depression), and how much their overall disease activity changed. Seven of the 14 participants completed the trial, and seven did not finish. The reported data shows that, on average, scores on the everyday functioning questionnaire (called the modified Multi-Dimensional Health Assessment Questionnaire, or mHAQ) decreased by 59% from the start of the trial to week 24. On this questionnaire, a lower score means less difficulty with daily tasks, so a decrease means participants were reporting less difficulty on average. For disease activity — measured using a tool called the Short Disease Activity Score, which takes into account things like joint tenderness, swelling, and self-reported pain — the reported data shows an average decrease of 31% from the start of the trial to week 24, where a lower score also indicates less activity. It is worth noting that this was a small trial with only 14 participants and no comparison group, meaning everyone received the same treatment and there was no separate group receiving a different or no treatment for comparison. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00124449 · results posted 19 November 2009

    According to the results reported on ClinicalTrials.gov, this trial enrolled 56 people in total — 28 received the medicine abatacept and 28 received a placebo (a dummy treatment with no active ingredient). The participants all had a condition called undifferentiated inflammatory arthritis, meaning joint inflammation that had not yet been formally diagnosed as a specific disease. The trial was trying to find out how many people went on to develop rheumatoid arthritis (a longer-term joint condition) over the course of the study, which included a six-month treatment phase followed by an 18-month observation period where no treatment was given. The reported data shows that for the main outcome — the number of people who either received a formal diagnosis of rheumatoid arthritis or left the study early because the treatment wasn't working for them — 12 out of 28 people in the abatacept group and 16 out of 28 in the placebo group met this measure. For a secondary version of this same measure using a slightly different set of diagnostic criteria, the reported numbers were 17 out of 28 in the abatacept group and 21 out of 28 in the placebo group. The reported data also shows scores measuring joint damage and inflammation (assessed by X-ray and MRI scans) at six months, 12 months, and 24 months, with various numerical changes from starting scores recorded for both groups across those time points. No participants in either group were reported to have developed a different rheumatic disease during the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00619177 · results posted 18 November 2009

    According to the results reported on ClinicalTrials.gov, this trial enrolled 3,569 people who were taking meloxicam (in doses of 7.5 mg tablets, 15 mg tablets, or injection form, marketed as MOVALIS®). Of those, 3,061 completed the trial and 508 did not. The trial was measuring changes in participants' physical and mental wellbeing, as well as their pain levels, over approximately four weeks of treatment. There was only one group in this trial — everyone received meloxicam — so there was no comparison group. The reported data shows that participants' physical wellbeing scores (measured using a standard health survey called the SF-12, where 0 is the lowest and 100 is the highest wellbeing) increased by an average of 11.2 points from the start of the trial to the end. Their mental wellbeing scores on the same survey increased by an average of 6.2 points over the same period. For pain, participants rated their pain on a scale of 0 (no pain) to 100 (severe pain); the reported data shows an average decrease of 41.9 points from their starting score to their final score. Because there was no comparison group, these numbers reflect what was recorded in this group only, and cannot be compared against an untreated group. The reported data also shows how participants and their doctors rated the overall results at the end of the trial using a five-point scale (1 = excellent, 5 = poor). Among participants, 803 rated the results as excellent, 1,540 as very good, 928 as good, 161 as fair, and 29 as poor. Doctors' ratings were similar: 879 rated results as excellent, 1,652 as very good, 806 as good, 109 as fair, and 21 as poor. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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  • NCT00264537 · results posted 13 July 2009

    According to the results reported on ClinicalTrials.gov, this trial enrolled 637 people with rheumatoid arthritis, divided into four groups of approximately 159–160 people each. The groups were: a placebo injection plus the existing medicine methotrexate; the drug golimumab at 100 mg plus a placebo (no methotrexate); golimumab at 50 mg plus methotrexate; and golimumab at 100 mg plus methotrexate. The trial was measuring two main things: how many participants showed a meaningful improvement in joint swelling, pain, and physical function scores at 24 weeks, and how much joint damage (as seen on imaging) had changed after 52 weeks. Not everyone finished the study — between 99 and 110 people in each group completed it. The reported data shows that for the main 24-week measure (called an ACR 50 response — meaning at least a 50% improvement across several joint and symptom scores), the numbers of participants who reached that point were: 47 out of 160 in the placebo-plus-methotrexate group, 52 out of 159 in the golimumab 100 mg-plus-placebo group, 64 out of 159 in the golimumab 50 mg-plus-methotrexate group, and 58 out of 159 in the golimumab 100 mg-plus-methotrexate group. For a less stringent improvement threshold (ACR 20, meaning at least 20% improvement), the reported numbers were 79, 82, 98, and 98 participants respectively across those same four groups. For the second main measure — change in a joint-damage score (on a scale of 0 to 448, where higher means more damage) after 52 weeks — the reported average changes from the starting point were: +1.37 in the placebo-plus-methotrexate group, +1.25 in the golimumab 100 mg-plus-placebo group, +0.74 in the golimumab 50 mg-plus-methotrexate group, and +0.07 in the golimumab 100 mg-plus-methotrexate group. The reported data also includes a subgroup of participants who had an elevated inflammation marker (C-reactive protein) at the start of the trial. In that subgroup, the joint-damage score changes reported were +2.16 (placebo plus methotrexate), +2.19 (golimumab 100 mg plus placebo), +1.29 (golimumab 50 mg plus methotrexate), and +0.16 (golimumab 100 mg plus methotrexate). These are simply the numbers that were recorded and reported — no interpretation of what they mean for any individual should be drawn from them alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.