Reported trial results for Lupus

Every Lupus 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.

86 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

NCT02822989 · results posted 8 July 2026

According to the results reported on ClinicalTrials.gov, this trial looked at a device that stimulates the vagus nerve (a major nerve running from the brain to the body) compared to a "sham" version — a fake device used as a control so that neither group knew for certain which treatment they were receiving. A total of 19 people took part: 13 in the vagus nerve stimulation group and 6 in the sham group. Twelve of the 13 in the active group and all 6 in the sham group completed the study. The trial was measuring changes in musculoskeletal (muscle and joint) pain, fatigue, and tender joint counts, as well as tracking any unwanted side effects. The reported data shows that, on a pain scale of 0 to 10, the vagus nerve stimulation group reported an average change of −5.00 points from their starting score, while the sham group reported an average change of +0.10 points. For fatigue — measured on a questionnaire where higher scores mean less fatigue — the vagus nerve stimulation group reported average improvements of 11 to 12 points, compared to changes of 0 to −2 points in the sham group. On tender joints, the reported data shows the vagus nerve stimulation group had a 100% reduction in tender joints from their starting count, compared to 5.3% in the sham group. Regarding side effects, the reported data shows that 1 participant in the vagus nerve stimulation group experienced a moderate-or-higher treatment-related adverse event (an unwanted reaction considered at least moderately serious), compared to none in the sham group. It is worth noting that this was a very small trial — fewer than 20 people in total — so the numbers above reflect a limited group of participants 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 ↗
NCT05638802 · results posted 28 May 2026

According to the results reported on ClinicalTrials.gov, this trial (NCT05638802) looked at an investigational medicine called DS-7011a in people with systemic lupus erythematosus (lupus), an autoimmune condition. A total of 25 people took part — 19 received DS-7011a and 6 received a placebo (a dummy treatment with no active ingredient). Of those, 16 in the DS-7011a group and 5 in the placebo group completed the trial. The trial was primarily measuring how many participants experienced unwanted health events (called treatment-emergent adverse events, or new or worsening health problems that appeared after starting the study drug). It also measured how the drug moved through the body over time, and tracked changes in the severity of lupus-related skin symptoms using two scoring tools. The reported data shows that 11 out of 19 participants in the DS-7011a group, and 4 out of 6 in the placebo group, experienced at least one such health event after starting their assigned treatment. For the drug's behaviour in the body, the reported data shows figures across what appear to be three different doses or timepoints: the amount of drug present in the blood over 28 days ranged from roughly 5,465 to 7,367 mg/L·day; the highest level of drug in the blood ranged from about 670 to 702 mg/L; and the lowest level in the blood ranged from about 80 to 153 mg/L. These measurements were only taken in the DS-7011a group, so no placebo comparison is available for these figures. For the two skin severity scores, the reported data shows that the DS-7011a group had an average change of −10.1 points on one skin scoring scale and −1.2 points on another, while the placebo group showed changes of +1.0 and −0.2 points respectively — where a negative number means the score went down from the starting 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.

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NCT01729455 · results posted 20 March 2026

According to the results reported on ClinicalTrials.gov, this trial enrolled 2,030 people taking a medicine called Benlysta (belimumab) and 937 people taking other lupus (SLE) medications, for a total of 2,967 participants. The trial was an observational registry study — meaning researchers followed people over time rather than randomly assigning treatments — designed to track specific "adverse events of special interest" (AESIs), which were pre-selected medical events researchers wanted to monitor closely. These included deaths, certain cancers, serious infections, opportunistic infections (infections that tend to occur when the immune system is under pressure), non-melanoma skin cancers, and serious psychiatric events. The reported data shows that, when looking at the total number of people who experienced at least one of these pre-selected events over the whole follow-up period, the Benlysta group recorded: 48 deaths, 44 non-skin cancers, 167 serious infections, 38 opportunistic infections, 44 non-melanoma skin cancers, and 10 serious psychiatric events. The non-Benlysta group recorded: 29 deaths, 24 non-skin cancers, 65 serious infections, 21 opportunistic infections, 19 non-melanoma skin cancers, and 4 serious psychiatric events. The reported data also shows event rates calculated per 100 person-years (a way of accounting for different lengths of follow-up time), tracked at 12, 24, 36, 48, and 63 months. These rates were broadly similar between the two groups across all time points and across all event categories, with no dramatic differences observed in the figures as reported. It is important to note that the two groups were different in size — the Benlysta group was roughly twice as large — and this was not a randomised trial, so the groups may have differed in other ways that could influence these numbers. 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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NCT04971590 · results posted 22 January 2026

According to the results reported on ClinicalTrials.gov, this study enrolled 193 people who had been diagnosed with lupus nephritis (a form of kidney inflammation linked to the autoimmune condition lupus). All 193 participants completed the study. Rather than testing a new treatment, this was an observational study — meaning it was designed to collect detailed information about who these patients were, what symptoms and other health conditions they had, what treatments they were already receiving, and how the condition affected their day-to-day quality of life. The reported data shows a range of findings across the group. In terms of health insurance, 143 participants had coverage and 50 did not. Looking at smoking, 164 participants were recorded as non-smokers. When it came to symptoms, joint pain or arthritis was the most commonly reported active symptom (94 participants), followed by high blood pressure (64 participants) and swelling in the feet (59 participants). A total of 134 participants had at least one other health condition alongside their lupus nephritis, and 60 participants had a high disease activity score (a score of 10 or above on a standard 0–105 scale, where a higher number means more active disease). Regarding treatments already in use, the most common were hydroxychloroquine (185 participants), prednisone (152 participants), and mycophenolate mofetil (133 participants), with participants often receiving more than one treatment at a time. The reported data also shows that quality of life was measured using a standard 36-item questionnaire (the SF-36), where scores run from 0 to 100 and a higher score represents better health. Across the eight areas measured, scores ranged from 49.7 (for general health) to 69.7 (for social functioning), with energy and fatigue scoring 57.7 and physical functioning scoring 67.6. 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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NCT04564339 · results posted 22 January 2026

According to the results reported on ClinicalTrials.gov, this trial enrolled 123 participants across two separate groups: people with a kidney condition called lupus nephritis (LN) — 38 receiving ravulizumab and 19 receiving a placebo (an inactive treatment) — and people with a kidney condition called IgA nephropathy (IgAN) — 43 receiving ravulizumab and 23 receiving a placebo. The trial was measuring changes in proteinuria, which means the amount of excess protein leaking into the urine — a sign that the kidneys may not be filtering properly. Participants were followed for up to 50 weeks, with a key measurement point at 26 weeks. The reported data shows the following for the primary measurement at 26 weeks. In the IgAN group, those receiving ravulizumab had an average reduction in urine protein of about 41.9%, compared with about 16.8% in the placebo group. In the LN group, those receiving ravulizumab had an average reduction of about 69.7%, compared with about 67.0% in the placebo group. By week 50 (a secondary measurement), the reported data shows the gap between ravulizumab and placebo had narrowed considerably in both groups: in the IgAN group the reductions were approximately 44.8% versus 45.1%, and in the LN group approximately 77.1% versus 75.0%. The reported data also shows that at week 26 in the IgAN group, 68.3% of ravulizumab participants had a greater than 30% reduction in urine protein compared with 40.9% in the placebo group, and 43.9% versus 18.2% had a greater than 50% reduction. Corresponding figures for the LN group at week 26 were 50.0% versus 73.7% for a greater than 30% reduction, and 47.4% versus 57.9% for a greater than 50% reduction. 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 ↗
NCT05162586 · results posted 1 December 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT05162586) looked at a medicine called enpatoran in people with lupus — a condition where the immune system can attack the body's own tissues. The trial was split into two groups: Cohort A (people with skin-affecting lupus) and Cohort B (people with a broader, more systemic form of lupus). In total, 456 people took part across all groups. Cohort A compared a placebo (a dummy treatment with no active ingredient) against three different doses of enpatoran — 25 mg, 50 mg, and 100 mg — over 16 weeks. Cohort B did the same across 24 weeks, but was structured across two parts. The reported data shows that for Cohort A, the main thing being measured was change in a skin disease score called CLASI-A (which runs from 0 to 70, where higher numbers mean more severe skin disease). At week 16, the placebo group's average score dropped by 5.0 points, while the three enpatoran groups dropped by 9.0, 10.2, and 9.7 points respectively. For Cohort B, the main measurement was how many participants met a specific set of criteria for overall disease improvement (called a BICLA response) at week 24. The reported data shows that out of those assessed, 37 participants in the placebo group met that response, compared with 41 in the 25 mg group, 36 in the 50 mg group, and 56 in the 100 mg group. The reported data also shows figures for a number of secondary measurements. The number of participants who experienced treatment-emergent adverse events (that is, any unwanted medical occurrence during the treatment period) ranged from 12 out of 26 in Cohort A's placebo group up to 70 out of 114 in Cohort B's 100 mg enpatoran group. Regarding abnormal laboratory test results at a severe level, zero participants across all groups were reported to have these. Similarly, zero participants across all groups were reported to have clinically important changes in a heart-rhythm measurement (QTcF). A skin severity rating by doctors (CLA-IGA, on a 0–4 scale) was also measured; for Cohort A at week 16, the placebo group's average score dropped by 0.9 points, while the enpatoran groups dropped by 1.7, 1.5, and 1.8 points respectively; the Cohort B figures for this measure at week 24 were 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.

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NCT05097989 · results posted 15 October 2025

According to the results reported on ClinicalTrials.gov, this trial looked at a drug called ALXN2050 in two separate groups of people with kidney conditions: one group had IgA nephropathy (IgAN), a condition where the immune system damages the kidneys, and the other had lupus nephritis (LN), a kidney complication of the autoimmune disease lupus. In the IgAN group, 9 people received the lower dose (120 mg), 26 received the higher dose (180 mg), and 26 received a placebo (a dummy treatment). In the LN group, 6 received the 120 mg dose, 17 received the 180 mg dose, and 16 received a placebo. The main thing being measured was the change in protein levels in the urine — having too much protein in the urine is a sign that the kidneys are not working as they should. Participants were followed through an initial 26-week period, an extended 24-week period, and a longer open-label phase. The reported data shows that at 26 weeks, protein in the urine had decreased across all groups. In the IgAN group, the 120 mg dose group showed a reported decrease of 29.3%, the 180 mg dose group showed a decrease of 26.2%, and the placebo group showed a decrease of 10.3%. In the LN group, the reported decreases were larger: 84.0% for the 120 mg group, 58.0% for the 180 mg group, and 55.4% for the placebo group. At 50 weeks, the reported data shows continued decreases in protein levels across most groups, including in IgAN participants who had switched from placebo to active treatment. For kidney filtration rate (a measure of how well the kidneys clean the blood), changes reported at both time points were small and varied across groups. For the LN group specifically, the reported data shows that at 26 weeks, 25% of the 120 mg group and 14.3% of the 180 mg group met the criteria for a "complete renal response" (a combined measure of improved protein levels, stable kidney function, and no need for extra treatment), compared with 9.1% in the placebo group; however, these proportions shifted at 50 weeks, with the placebo group reporting higher rates than the active treatment groups at that later 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 ↗
NCT03735238 · results posted 10 October 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,895 people with lupus (also known as systemic lupus erythematosus, or SLE) across multiple specialist clinics in the United States. The trial was testing how well a "patient decision aid" — a tool designed to help people with lupus understand their treatment options and take part in decisions about their care — could be introduced into real-world clinic settings. The study ran from 2019 to 2023, and 1,866 participants completed the study, with 29 not completing it. The reported data shows that the primary measure looked at what proportion of eligible lupus patients at each clinic actually viewed the decision aid. The numbers varied considerably by clinic site — for example, the reported data shows figures ranging from 63 participants at one site (Baylor College of Medicine) up to 725 at another (University of Alabama at Birmingham). Note that results for three of the fifteen listed clinic sites were not reported in the data. The trial also measured what clinic staff thought about the decision aid at three points in time: 4 months, 12 months, and 24 months after it was introduced. Staff rated the tool on several scales from 1 to 5 (where higher means more positive). The reported data shows scores for acceptability ranging from 3.53 to 3.84, appropriateness from 3.43 to 3.76, feasibility from 3.44 to 3.61, implementation success from 3.41 to 3.54, and perceived permanence (how likely staff felt the tool would stay in use) from 3.02 to 3.22 across the three 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 ↗
NCT04835441 · results posted 15 August 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04835441) enrolled 76 people with systemic lupus erythematosus (lupus) — 38 received the investigational drug acazicolcept (also called ALPN-101) and 38 received a placebo (an inactive treatment). By the end of the study, 33 people in the acazicolcept group and 32 in the placebo group had completed the trial. The trial was measuring safety (through tracking unwanted medical events), as well as how well participants' lupus disease activity responded to treatment, using several established lupus scoring tools. The reported data shows that for the safety primary outcome, 23 out of 38 participants in the acazicolcept group and 24 out of 38 in the placebo group experienced treatment-emergent adverse events (unexpected medical events that occurred during the study), while 2 participants in each group experienced serious adverse events. For the two disease-activity primary outcomes, 27% of participants in the acazicolcept group met the criteria for the SRI-4 response measure (a combined scoring tool that looks at overall lupus activity), compared with 46% in the placebo group. Using a second combined scoring tool called BICLA, 22% of the acazicolcept group met the response criteria, compared with 32% in the placebo group. Among the secondary outcomes, the reported data shows the acazicolcept group experienced approximately 3.27 flare-ups (periods of worsening symptoms) per person per year compared with 2.80 in the placebo group; the average time to a first flare-up was 85 days in the acazicolcept group versus 113 days in the placebo group; and 14% of the acazicolcept group versus 16% of the placebo group reached a "low disease activity state" (a defined threshold of well-controlled lupus). 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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NCT04908865 · results posted 23 July 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04908865) enrolled 67 children or young people with lupus (a condition where the immune system attacks the body's own tissues) who received the medicine belimumab. Of those who started, 59 completed the study. The trial tracked participants over 52 weeks and measured things like disease activity using a scoring tool called SELENA-SLEDAI (which runs from 0, meaning no disease activity, to 105, meaning very high activity), as well as doctors' and parents' own ratings of how the condition appeared to be affecting the participant. The reported data shows that, looking at a key primary outcome — a meaningful drop (4 or more points) in the disease activity score by week 52 — 44 out of 67 participants recorded that level of reduction. When looking at that same measure across each check-in visit throughout the year, the reported percentages of participants showing that degree of score reduction ranged from roughly 40% at the earliest visit up to around 75% at one of the later visits. The reported data also shows that doctors' assessments of disease activity (on a scale of 0–3) shifted by an average of about −0.93 points from the start to week 52, and parents' ratings of how poorly the illness was affecting their child (on a scale of 0–10) shifted by an average of about −2.71 points — both figures representing movement toward the lower (less active/better) end of their respective scales. Regarding monitored safety events over the 52 weeks, the reported data shows that 56 of the 67 participants experienced at least one adverse event (an unwanted medical occurrence during the study), and 19 experienced a serious adverse event (one meeting stricter criteria such as requiring hospitalisation). For a specific category of closely watched events — including things like infections, allergic reactions, or mental health concerns — 2 participants recorded an event in the infections category, and none were recorded in the other watched categories. 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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NCT04294667 · results posted 24 April 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04294667) enrolled 321 people with lupus — 108 in the placebo plus standard care group and 213 in the investigational treatment (DZP) plus standard care group. The trial's main goal was to measure how many participants met a set of defined criteria for disease improvement — called a "BICLA response" — by week 48. This involved tracking changes in disease activity scores as rated by doctors and specialists, without any worsening in other measures. A number of secondary goals were also tracked at earlier time points and included other disease activity measures. The reported data shows that, at week 48 (the primary measure), approximately 34.6% of participants in the placebo plus standard care group met the BICLA response criteria, compared with approximately 49.5% in the DZP plus standard care group. At earlier check-ins, the reported data shows similar patterns: at week 24, the figures were 38.3% versus 46.6%, and at week 12, they were 29.0% versus 39.9%. For a secondary measure looking at whether participants avoided a severe disease flare through to week 48, the reported figures were 76.6% in the placebo group and 88.4% in the DZP group. Regarding a measure of low disease activity maintained across at least half of all check-up visits, 15.9% of the placebo group and 23.6% of the DZP group met that threshold. A disease activity scoring tool (rated 0–105, where higher numbers mean more active disease) showed an average change from the starting point of −4.2 in the placebo group and −6.1 in the DZP group by week 48. 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 ↗
NCT04128579 · results posted 18 April 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04128579) tested a drug called EQ001 (also known as itolizumab) across 52 participants in total. Participants were divided into six groups based on either the type of condition they had or the dose they received — ranging from 0.4 mg/kg up to 3.2 mg/kg. The trial's main focus was on tracking unwanted medical events (called "treatment-emergent adverse events") that occurred during the study period, using a standard medical checklist to record them. The reported data shows the number of participants in each group who experienced these unwanted medical events. In the lowest-dose Type A group (0.4 mg/kg, 6 participants), zero participants had such events recorded. In the Type B group (17 participants), all 17 had events recorded. In the 0.8 mg/kg group (7 participants), 2 had events recorded; in the 1.6 mg/kg group (7 participants), 4 did; in the 2.4 mg/kg group (6 participants), 3 did; and in the highest-dose group of 3.2 mg/kg (9 participants), 8 had events recorded. It is worth noting that not all participants who started the trial completed it — for example, 5 of the 9 people in the highest-dose group did not finish. The reported data shows that two secondary outcomes — one looking at how the drug moves through the body over time, and one measuring how much of a particular protein (called CD6) on immune cells was bound by the drug — were listed as planned measures, but no numerical results were reported for either of these 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.

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NCT05048238 · results posted 21 March 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT05048238) enrolled 7 people, all of whom received the drug tofacitinib. Six participants completed the study and one did not. The trial was measuring how tofacitinib affected the skin's response to ultraviolet B (UVB) light — specifically, how many skin cells were dying (a process called apoptosis) after UV exposure, how much UV light was needed to cause visible redness, changes in the activity of inflammation-related genes in the skin, and the severity of skin lupus symptoms as rated by a doctor using a standard scoring tool called CLASI. The reported data shows that before treatment, the level of UVB-triggered dying skin cells was around 20–21.5% of all skin cells measured. After approximately 25 days of treatment, that figure was reported to have dropped to around 3–3.5%, representing a change of roughly minus 17 to minus 18 percentage points. For the CLASI activity score — a doctor-rated measure of skin lupus severity on a scale of 0 to 70, where higher means more severe — the reported average was 2.8 before treatment and 2.3 after, a change of minus 0.5 points. The CLASI damage score (scale 0 to 56) went from an average of 3.3 to 2.8, also a change of minus 0.5 points. For the minimum amount of UV light needed to cause redness, individual participant counts were reported across different dose levels rather than a single summary number, and for the gene activity measurements, individual participant figures were reported across multiple genes. Full summary averages for those two outcomes were not reported in the submitted data. It is worth noting that this was a very small study with only 7 participants, which limits how much can be read into these numbers. 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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NCT03915652 · results posted 22 January 2025

According to the results reported on ClinicalTrials.gov, this trial involved 35 people with lupus, split into two groups: 18 in "Wave 1" and 17 in "Wave 2." The trial was testing a care management programme (called Rheum iCMP) aimed at people with lupus, and it measured things like how often participants missed specialist appointments, how often they needed emergency or hospital care, the overall quality of their lupus care, how well they took their medications, their feelings about their medications, and their self-reported lupus disease activity — all tracked over 12 months. The reported data shows the following numbers at the end of the study. For missed or cancelled lupus-related appointments, the average figures reported were 6.2 (Wave 1) and 5.2 (Wave 2). For combined emergency department visits and hospitalisations, the averages were 1.29 (Wave 1) and 1.17 (Wave 2). For quality of lupus care, measured as the percentage of recommended care steps still not completed at 12 months (where a higher number means more care steps were left undone), the reported averages were 64% (Wave 1) and 53% (Wave 2). On the medication-taking self-report scale (0–100, where 100 means perfect adherence), the reported averages were 65 (Wave 1) and 98.8 (Wave 2). On the beliefs about medications scale (5–25, where higher means more negative feelings), the averages were 2.13 (Wave 1) and 1.4 (Wave 2) — noting these figures fall outside the stated scale range, so this data should be interpreted with caution. For self-reported lupus disease activity (0–46, where higher means more activity reported), the averages were 11 (Wave 1) and 14.3 (Wave 2). The reported data does not include before-and-after comparison figures, so it is not possible from this data alone to describe how much, if at all, these numbers changed from the start of 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.

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NCT05123586 · results posted 20 January 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT05123586) enrolled 85 people in total — 42 received a treatment called LY3361237 (at a dose of 450 milligrams) and 43 received a placebo (a dummy treatment with no active ingredient). The trial was looking at whether LY3361237 could reduce symptoms of systemic lupus erythematosus (lupus), specifically joint pain/swelling (arthritis) and skin rash, in people who had those symptoms when they joined the study. The main question the trial set out to answer was how many participants saw those symptoms go into remission (meaning the symptom was no longer present) by Week 24. The reported data shows that, for the primary measure — remission of arthritis and/or rash by Week 24 — approximately 11.9% of participants in the LY3361237 group reached that goal, compared with 20.9% in the placebo group. For two secondary measures, both looking at reductions in overall lupus disease activity using standard scoring tools, approximately 9.5% of participants in the LY3361237 group met the target score reduction, compared with 16.3% in the placebo group. In all of these measures, the reported percentages were lower in the LY3361237 group than in the placebo group. The reported data also shows a blood concentration measurement for LY3361237 at Week 24 in the treatment group (144 micrograms per millilitre), which reflects how much of the drug was present in participants' blood; no equivalent figure applies to the placebo group. Of the 85 people who started the trial, 80 completed it (41 in the LY3361237 group and 39 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.

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NCT04451772 · results posted 14 January 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04451772) involved people with systemic lupus erythematosus (SLE) — a long-term autoimmune condition. A total of 185 participants were enrolled across six groups, each receiving different combinations or doses of two investigational medicines, elsubrutinib and upadacitinib (together called ABBV-599), or placebo versions of one or both. The trial was measuring how many participants experienced medical events after starting treatment (the primary goal), as well as tracking lupus disease activity scores, steroid dose changes, and flare rates over time (secondary goals). The reported data shows that for the primary outcome — counting participants who had a treatment-emergent adverse event (an unwanted medical occurrence that happened during or shortly after taking the study drug) — the numbers ranged from 7 to 34 participants out of each group, depending on which group. Serious adverse events were reported in 1 to 5 participants per group. For the secondary outcomes, the percentage of participants meeting standard lupus disease activity response measures (called SRI-4 and BICLA — scoring tools doctors use to gauge lupus activity) ranged roughly from 54% to 89% across the three groups reported, depending on the time point and group. The reported data also shows that daily steroid (prednisone) doses decreased from the starting point by approximately 3.5 to 5.2 milligrams across groups over the course of the study. Reported lupus flare rates (episodes of worsening symptoms) ranged from 0.00 to 1.56 events per patient-year across the 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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NCT04181762 · results posted 10 October 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04181762) enrolled 137 people in the secukinumab 300 mg group and 138 people in the placebo group — 275 participants in total. The trial was measuring whether secukinumab, compared to a placebo (an inactive treatment), could help people with lupus nephritis (a form of kidney disease linked to lupus) achieve certain kidney recovery targets over 52 weeks (about one year). The main thing being measured was something called a "Complete Renal Response" — a combined measure requiring kidney filtration function to be at or near normal, protein levels in urine to be very low, no early drop-out from the study, and only low doses of steroid medicines used near the end of the study period. The reported data shows that at week 52, approximately 25.9% of participants in the secukinumab group and 38.6% of participants in the placebo group met the criteria for a Complete Renal Response — meaning a higher proportion of the placebo group reached this target than the secukinumab group, as reported. For the secondary outcomes, a "Partial Renal Response" (a less strict kidney improvement measure) at week 52 was reported in 56.2% of the secukinumab group and 63.9% of the placebo group. At week 24 (the halfway point), a partial response was reported in 52.8% of the secukinumab group and 43.6% of the placebo group. Protein levels in the urine (measured as UPCR — a ratio used to detect kidney stress) decreased from the starting point in both groups: by about 2.2 units in the secukinumab group and about 2.7 units in the placebo group. The average daily dose of oral steroids used between weeks 16 and 52 was reported as approximately 8.1 mg/day in the secukinumab group and 7.5 mg/day in the placebo group. It is also worth noting that the reported data shows a large number of participants did not complete the study — 114 in the secukinumab group and 115 in the placebo group — which the trial accounted for using a standard statistical method (called "non-responder imputation"), where anyone without a recorded result was counted as not having responded. 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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NCT04058028 · results posted 24 September 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04058028) enrolled 244 adults with systemic lupus erythematosus (lupus) across four groups: 62 received a placebo (a dummy treatment with no active ingredient), 58 received a 70 mg dose of rozibafusp alfa, 36 received a 280 mg dose, and 88 received a 420 mg dose. The trial's main goal was to measure how many participants met a set of pre-defined criteria — known as an "SRI-4 response" — showing improvement in their lupus disease activity at 52 weeks, without their overall condition getting worse in other ways. The reported data shows that, for the primary measure at 52 weeks, 26 out of 62 placebo participants, 29 out of 58 in the 70 mg group, 21 out of 36 in the 280 mg group, and 35 out of 88 in the 420 mg group met the SRI-4 response criteria. For the secondary measures, the reported data shows that at 24 weeks, 33 placebo, 30 (70 mg), 20 (280 mg), and 46 (420 mg) participants met the SRI-4 criteria. A different disease-activity measure called BICLA response at 52 weeks was met by 21 placebo, 20 (70 mg), 15 (280 mg), and 29 (420 mg) participants. For a "low disease activity" measure at 52 weeks, the numbers were 12, 18, 6, and 21 respectively. A smaller sub-group measure — looking at people who also managed to reduce their steroid dose to a low level and sustain that through to week 52 — was met by 5 placebo, 1 (70 mg), 2 (280 mg), and 8 (420 mg) participants. It is also worth noting that not all participants completed the study — for example, 26 of the 62 placebo participants and 42 of the 88 highest-dose participants did not complete it, though the reasons were not detailed 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.

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NCT05430854 · results posted 19 September 2024

According to the results reported on ClinicalTrials.gov, this trial was an open-label extension (OLE) study — meaning a follow-on phase where all participants received active treatment after a previous trial had ended. A total of 155 people took part across three groups, depending on what they had received in the earlier study: 47 who had previously been on a placebo before switching to daxdilimab every 12 weeks, 57 who had previously received daxdilimab every 4 weeks before continuing on every 12 weeks, and 51 who had been on daxdilimab every 12 weeks throughout. The trial was primarily measuring how many participants experienced adverse events (unexpected or unwanted medical occurrences) during the study, as well as tracking the drug's levels in the blood and how the body responded to it over time. The reported data shows that across the three groups, 25, 31, and 31 participants respectively experienced at least one adverse event during the study period. Serious adverse events — defined as those leading to hospitalisation, being life-threatening, or causing significant disability — were reported in 3, 5, and 5 participants across the three groups. A smaller number experienced what the researchers called "adverse events of special interest" (certain specific medical concerns they were watching closely), with 1, 2, and 1 participants in each group respectively. Regarding the drug's levels in the blood, the reported data shows varying concentrations across time points and groups, with the highest early reading (5.527 micrograms per millilitre) seen in the group that had been on the more frequent dosing schedule in the prior study. The reported data also shows that the number of participants who developed antibodies against the drug (a marker the researchers tracked) was 34, 48, and 44 across the three groups when looking at the total number assessed. For the secondary outcomes, the reported data shows changes in a type of immune cell called plasmacytoid dendritic cells (a specific blood cell the researchers were monitoring) varied across groups and time points, with some groups showing reductions and others showing increases at different stages. It is worth noting that a large proportion of participants did not complete the study — only 8, 4, and 5 finished across the three groups — though the reasons for this were not detailed 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.

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NCT03845517 · results posted 5 September 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 350 adults across four groups: 100 received a placebo (a dummy treatment with no active ingredient), 50 received 15 mg of the investigational medicine PF-06700841, 101 received 30 mg, and 99 received 45 mg. All participants had systemic lupus erythematosus (lupus). The trial ran for 52 weeks of treatment followed by a 4-week follow-up period. The main thing being measured was how many participants in each group met a set of standard lupus scoring criteria — known as the SRI-4 — at the end of 52 weeks. This scoring system combines three separate assessments of disease activity and overall health as rated by a doctor. The reported data shows that for the main measure (SRI-4 response at week 52), 64.6% of placebo participants, 57.4% of the 15 mg group, 69.7% of the 30 mg group, and 66.3% of the 45 mg group met the criteria. For several secondary measures, the reported data shows: on a second combined scoring system (BICLA), 43.8% placebo, 42.6% (15 mg), 52.5% (30 mg), and 53.3% (45 mg) responded. For reaching a "low disease activity" state, figures were 22.6%, 21.3%, 35.1%, and 34.1% respectively. Among participants who started the trial on higher steroid doses, the proportion who managed to reduce their steroid dose to a lower level and keep it there for 12 weeks was 26.4% (placebo), 36.4% (15 mg), 37.0% (30 mg), and 41.9% (45 mg). For skin-related disease scoring, percentages achieving at least a 50% improvement were 73.9% (placebo), 58.3% (15 mg), 77.8% (30 mg), and 56.3% (45 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.

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NCT05232864 · results posted 30 August 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT05232864) enrolled 31 people in total — 16 received secukinumab 300 mg and 15 received a placebo (an inactive dummy treatment). The trial was measuring whether secukinumab could help people achieve what is called a "Complete Renal Response" (CRR) — a combined measure of kidney function that looks at two things: how well the kidneys are filtering blood, and how much protein is leaking into the urine. Notably, the data shows that none of the participants in either group are recorded as having "completed" the study, and all are listed under "not completed," though no further explanation for this is provided in the submitted data. The reported data shows that, for the primary outcome, 4 out of 16 participants in the secukinumab group and 5 out of 15 participants in the placebo group achieved a Complete Renal Response at one reported time point. At a second reported time point, the numbers were 3 out of 16 in the secukinumab group and 5 out of 15 in the placebo group. The data does not include additional context about when these time points occurred or why two separate sets of numbers were reported, and no further breakdown was provided 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.

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NCT03107442 · results posted 22 August 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT03107442) enrolled 58 people in total — 26 in an Exercise group and 32 in a Control group. By the end of the study, 18 people in the Exercise group and 28 in the Control group had completed it, with 8 and 4 people respectively not finishing. The trial was measuring arterial stiffness (how stiff the arteries are, measured by how fast a pulse wave travels through them) as its main focus, along with several blood markers including inflammation, blood sugar, insulin, and a longer-term measure of blood sugar control called HbA1c (a percentage that reflects average blood sugar over roughly three months). The reported data shows that for the main outcome — arterial stiffness measured in metres per second — the Exercise group showed a change of −0.26 m/s and the Control group showed a change of −0.22 m/s (a negative number meaning a reduction from their starting point). For the secondary blood measurements, the reported changes in the Exercise group compared to the Control group were: inflammation marker hs-CRP changed by +0.17 mg/L (Exercise) versus −0.24 mg/L (Control); blood glucose changed by −3.12 mg/dL (Exercise) versus +4.47 mg/dL (Control); insulin changed by −0.32 units (Exercise) versus +0.30 units (Control); the insulin resistance index (HOMA-IR, a calculated score combining glucose and insulin) changed by −0.1 (Exercise) versus +0.22 (Control); and HbA1c changed by −0.02% (Exercise) versus +0.10% (Control). These figures represent the average change from the beginning to the end of the study within each group. It is worth noting that the data as submitted does not include information about whether the differences between the two groups were statistically meaningful (a way of judging whether a difference is likely to be real or due to chance), so those figures alone cannot tell us how significant the differences are. 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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NCT04141046 · results posted 27 June 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04141046) looked at a brain stimulation technique called transcranial alternating current stimulation (tACS) — a method that delivers very mild electrical signals to the scalp to try to influence brain activity. The trial had three groups: one that received a "sham" (inactive/pretend) stimulation, one that received stimulation at a "theta" frequency, and one at an "alpha" frequency. In total, only 4 people participated — 1 in the sham group, 0 in the theta-tACS group, and 3 in the alpha-tACS group — and all who started the trial completed it. The main thing being measured was a change in "alpha oscillation power," which refers to a particular pattern of electrical activity in the brain (in the 8–12 Hz range) recorded by a brainwave (EEG) cap worn during rest. The reported data shows that for the primary outcome — change in alpha brain activity (measured in microvolts²/Hz) — the sham group showed a change of +0.146, while the alpha-tACS group showed a change of −0.015. No result was reported for the theta-tACS group, likely because no participants were enrolled in that group. For all of the secondary outcomes — which looked at possible links between brain activity and scores on questionnaires measuring depression, anxiety, mood, pain, general health, and fatigue — the reported data shows that no measurements were submitted to ClinicalTrials.gov. It is also worth noting that with only 4 participants across all groups, this was an extremely small study, and the data as reported is very limited. 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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NCT00779194 · results posted 12 June 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT00779194) looked at people with a condition called systemic lupus erythematosus (SLE), which is an autoimmune disease. A total of 43 people with SLE received the study drug, and 56 people without the condition were included as a comparison group (controls). Of the 43 SLE participants, 29 completed the study, while 14 did not finish. The trial was measuring changes in lupus disease activity using two standard scoring tools — the SLEDAI (a 0–105 scale where higher numbers mean more active disease) and the BILAG (a 0–97 scale where higher numbers also mean more active disease) — as well as how much of a steroid medicine called prednisone was needed to keep the condition under control. The reported data shows that, among the SLE participants who received the study drug, the SLEDAI score was reported as 10.2 at one point and 28.4 at another point during the study, though the data as submitted does not clearly label which figure corresponds to the start or end of the treatment period. For the BILAG score, the same two figures (10.2 and 28.4) appear to have been reported, though the submission does not separately distinguish the two scores in the results table, so it is not possible to say with certainty which number belongs to which tool. Regarding prednisone use, the reported data shows the average daily dose among SLE participants was 24.3 mg per day at the beginning of the study, and 7.2 mg per day at the end of the 12-month treatment period. No outcome data was reported for the control group in the results submitted to ClinicalTrials.gov, so no comparison between the two groups can be drawn from the available 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.

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NCT03656562 · results posted 6 June 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT03656562) enrolled 107 people with lupus (systemic lupus erythematosus) across two groups. In the first group (Cohort 1), 34 people received a treatment called VAY736 and 33 received a placebo (an inactive dummy treatment). In the second group (Cohort 2), 20 people received a treatment called CFZ533 and 20 received a placebo. The trial was measuring whether participants met a combined target at week 29: showing meaningful improvement in their lupus disease activity score while also being able to maintain a reduced dose of steroid medication. The reported data shows that, for the main outcome measure at week 29, 15 out of 34 participants in the VAY736 group met the combined target, compared with 3 out of 33 in the VAY736 placebo group. In Cohort 2, 8 out of 20 participants in the CFZ533 group met the combined target, compared with 6 out of 20 in the CFZ533 placebo group. For the secondary outcomes, doctors' and patients' own ratings of disease activity (each scored on a 0–100 scale, where lower means less disease activity) generally showed reductions from the starting point across all groups by week 29, though the reported figures varied between groups. The reported data also shows that flares (a sudden worsening of lupus symptoms) were recorded in varying proportions across the groups at different time points 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.

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NCT04433585 · results posted 23 April 2024

According to the results reported on ClinicalTrials.gov, this trial tested three different doses of a drug called LY3471851 — a high dose, a middle dose, and a low dose — compared to a placebo (a dummy treatment with no active ingredient) in people with lupus, a condition where the immune system attacks the body's own tissues. A total of 291 people took part across the four groups (73 in the high-dose group, 70 in the middle-dose group, 74 in the low-dose group, and 74 in the placebo group). The trial's main goal was to measure how many participants had a meaningful reduction in their lupus disease activity score — using a standard lupus scoring tool — after 24 weeks. The reported data shows that for the primary (main) outcome — the proportion of people whose lupus disease activity score dropped by at least 4 points at 24 weeks — the figures were: 20% in the high-dose group, 27% in the middle-dose group, 22% in the low-dose group, and 22% in the placebo group. The trial also measured several secondary (additional) outcomes. For a different disease activity measure called BICLA response, the reported figures were 12% (high dose), 26% (mid dose), 18% (low dose), and 18% (placebo). For another measure called SRI-4 response, the figures matched the primary outcome: 20%, 27%, 22%, and 22% respectively. For reaching a "low disease activity state" — a defined level of reduced lupus activity — the reported figures were 12% (high dose), 18% (mid dose), 11% (low dose), and 10% (placebo). The reported data also shows drug levels measured in participants' blood just before each new dose was given: the average level was 214.4 ng/mL (nanograms per millilitre, a measure of concentration) in the high-dose group, 133.3 ng/mL in the middle-dose group, and 55.9 ng/mL in the low-dose group. It is also worth noting that fewer participants in the high-dose group completed the study (44 out of 73) compared to the placebo group (65 out of 74), though the reasons for this were not detailed 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.

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NCT04179032 · results posted 26 March 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 25 participants, all of whom received a weekly self-injected dose of belimumab (200 mg). The trial was primarily focused on measuring how much of the drug was present in participants' blood at various points in time — in other words, it was looking at how the body absorbed and held onto the medication, rather than directly measuring whether a disease got better or worse. All 25 participants completed the first phase (up to week 12), 23 of the 25 completed the second phase (up to week 52), and 11 entered an extended access phase, though none had completed that phase at the time results were reported. The reported data shows that at week 12, the observed average belimumab level in the blood was 106.42 micrograms per millilitre (a measure of how much drug was present in a small amount of blood). Once the drug levels had stabilised over time (referred to as "steady state"), the estimated average blood concentration across the full study period was 124 micrograms per millilitre, the estimated peak (highest) level was 131 micrograms per millilitre, and the estimated trough (lowest) level was 112 micrograms per millilitre. The reported data also shows that 22 out of 25 participants experienced at least one adverse event (an unexpected medical occurrence during the study), and 1 out of 25 participants experienced a serious adverse event — defined as one that was life-threatening, required hospitalisation, or resulted in lasting disability or death. The trial results do not provide a breakdown of what those events were, and no further detail on those events was included 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.

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NCT03393013 · results posted 8 March 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT03393013) tested an investigational drug called zetomipzomib (also known as KZR-616), given as a weekly injection under the skin, in adults with systemic lupus erythematosus (lupus) — including those with and without kidney involvement (lupus nephritis). The trial ran in two stages: a Phase 1b safety-focused stage, where 47 people were enrolled across six different dosing groups, and a Phase 2 stage, where 22 people took part in a single dosing group. All participants received the study drug alongside their usual standard-of-care treatment. The reported data shows the following. In the Phase 1b stage, the main thing being counted was how many participants in each group experienced at least one side effect considered to be related to the study drug. The numbers reported were: 7 out of 8 in the 45 mg group, all 5 in the 60 mg group, 11 out of 14 in one step-up dosing group, 3 out of 6 and 6 out of 8 in two other step-up groups, and 3 out of 6 in the 75 mg group. The trial also tracked how the drug moved through the body (for example, how quickly it reached its highest level in the blood), with higher doses generally showing higher drug levels — though what these numbers mean clinically is not stated here. In the Phase 2 stage, the main thing being measured was how many participants with lupus nephritis showed a 50% or greater reduction in a urine protein-to-creatinine ratio (a measure used to track kidney inflammation) after 24 weeks. The reported data shows that 11 out of 22 participants met this threshold. A related secondary measure — a stricter definition of kidney response — was reported to be met by 10 out of 22 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.

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NCT04186871 · results posted 16 January 2024

According to the results reported on ClinicalTrials.gov, this trial looked at a drug called branebrutinib across three different autoimmune conditions: systemic lupus erythematosus (SLE, a disease where the immune system attacks the body's own tissues), primary Sjögren's syndrome (pSS, a condition affecting moisture-producing glands), and rheumatoid arthritis (RA, a condition causing joint inflammation). In total, 119 people took part — 20 in the SLE groups, 14 in the pSS groups, and 85 in the RA groups. Each condition had participants randomly assigned to receive either branebrutinib or a placebo (a dummy treatment with no active ingredient). The trial measured specific disease activity scores at set time points to compare the two groups. The reported data shows the following numbers for each condition's main (primary) outcome. For SLE, the trial measured the percentage of people showing a meaningful improvement in a skin-related disease score while also keeping their steroid dose low: 60% of those on placebo met this combined measure, compared with 33.3% of those on branebrutinib. For pSS, the trial looked at the percentage of people who improved across a combination of at least three different disease measures: 25% of the placebo group met this, compared with 10% of the branebrutinib group. For RA, the trial measured the percentage of people whose joint tenderness, swelling, and overall symptoms improved by at least 50%: 33.3% of the placebo group reached this, compared with 18.8% of the branebrutinib group. The reported data also shows results for several secondary (additional) outcomes. In SLE, both the branebrutinib and placebo groups showed the same average change in an overall disease activity score (a reduction of 7.0 points each), and a separate measure of lupus response showed 33.3% of the branebrutinib group and 20% of the placebo group met the criteria. In RA, a score combining joint counts and blood inflammation markers decreased by an average of about 1.54 points in the branebrutinib group and 1.62 points in the placebo group. Where data for any specific measure was not separately detailed beyond what is listed above, it 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.

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NCT03978520 · results posted 21 July 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT03978520) enrolled 341 adults with systemic lupus erythematosus (lupus) across five groups. The groups tested different combinations of two investigational medicines — elsubrutinib and upadacitinib (together called ABBV-599) — against placebo (inactive treatment) or either medicine alone. The trial's main goal was to measure how many participants met a recognised lupus response standard (called SRI-4) *and* had their steroid dose reduced to a low level after 24 weeks. A number of additional measures were also tracked, including overall disease response, disease activity scores, steroid dose changes, and how often flares (sudden worsening of symptoms) occurred. The reported data shows that for the primary measure at 24 weeks, 37.3% of participants in the placebo group met the combined SRI-4 and low-steroid target, compared with 48.5% in the high-dose ABBV-599 group and 54.8% in the upadacitinib-alone group. For a similar but slightly broader response measure (SRI-4 without the steroid requirement), the reported figures were 38.7% (placebo), 54.4% (high-dose ABBV-599), and 56.5% (upadacitinib alone). On a separate disease-activity measure called BICLA response, the reported percentages were 42.7%, 54.4%, and 58.1% respectively. For reaching a "low disease activity state," the reported figures were 13.3%, 30.9%, and 45.2%. Changes in daily steroid dose were small across all groups (ranging from approximately −0.45 mg to −0.65 mg). The reported data shows that the number of disease flares per year was lower in the active-treatment groups compared with placebo, though the exact breakdown across flare subtypes contained some repeated data entries that were not fully distinguishable in the submitted results. It is also worth noting that notably fewer participants in the two low-dose combination and elsubrutinib-alone groups completed the study compared with the placebo and other groups, which the reported data does not fully explain. 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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NCT03451422 · results posted 19 July 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT03451422) enrolled 35 people in total. Ten participants received a placebo (an inactive substance used for comparison), while the remaining 25 received different doses of the investigational drug AMG 592, split across five groups (Cohorts 1–5) of four to seven people each. The trial was primarily measuring how many participants experienced any unwanted medical events (called adverse events) after receiving the study drug, and secondarily tracking how the drug moved through the body — including how high the drug levels peaked in the blood, how long it took to reach that peak, and how much of the drug was present over time. The reported data shows that, for the primary outcome, 7 out of 10 placebo participants and virtually all AMG 592 participants across the dose groups experienced at least one adverse event (5 of 5 in Cohort 1, 5 of 5 in Cohort 2, 7 of 7 in Cohort 3, 3 of 4 in Cohort 4, and 4 of 4 in Cohort 5). For the secondary outcomes related to how the drug behaved in the body, the reported peak blood concentration of AMG 592 ranged from around 7.9 to 56.5 nanograms per millilitre across the dose groups and measurement time points, with the time to reach that peak ranging from roughly 17 to 48 hours. The overall amount of drug in the blood over a dosing period ranged from approximately 538 to 3,770 units (hour×ng/mL) depending on the dose group and time point. The reported data also shows that some participants developed antibodies (proteins the body can produce in response to a foreign substance) against AMG 592 or a related substance (IL-2), with numbers varying across groups; neutralising antibodies (a type that can potentially block the drug's action) were detected in a small number of participants in some groups and none in 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.

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NCT03843125 · results posted 16 May 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT03843125) looked at a medicine called baricitinib in people with systemic lupus erythematosus (lupus), an autoimmune condition. A total of 1,147 participants took part, split across four groups: 388 received a 2 mg daily dose of baricitinib, 379 received a 4 mg daily dose, 189 received a placebo (dummy pill) matched to the 2 mg group, and 191 received a placebo matched to the 4 mg group. The trial's main focus was on tracking and recording side effects and any problems that arose during treatment, rather than measuring how well the medicine worked against lupus symptoms — though one secondary measure did look at disease response. The reported data shows that when it came to side effects that emerged or got worse during the study period, 61.9% of the 2 mg baricitinib group, 68.8% of the 4 mg baricitinib group, 65.1% of the placebo-to-2 mg group, and 64.4% of the placebo-to-4 mg group experienced at least one such event. For serious adverse events — meaning side effects serious enough to cause hospitalisation, be life-threatening, or have other major consequences — the reported figures were 11.1%, 13.5%, 11.1%, and 11.5% across the four groups respectively. A subset of specifically monitored events (such as infections, blood clots, and heart-related events) was reported in roughly 38–42% of baricitinib participants and 35–37% of placebo participants. Regarding temporary interruptions to the study medication, between about 19% and 25% of participants across all groups had their treatment paused at some point, while permanent stopping of the study drug was reported in roughly 4–6% across all groups. For the one secondary outcome — a combined lupus disease-response score — the reported data shows a result of zero for all four groups, meaning this particular measurement was not completed or data was not available for any participant in the way the trial defined 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.

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NCT03616912 · results posted 30 January 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT03616912) enrolled 830 participants across six groups to study baricitinib — a medicine taken as a daily tablet — in people with systemic lupus erythematosus (lupus). The main question the trial was trying to answer was whether a 4 mg daily dose of baricitinib led to more people achieving a recognised measure of lupus disease improvement (called an "SRI-4 response") compared with a placebo (dummy pill). A 2 mg daily dose and several other disease measures were also tracked as secondary questions. Participants were followed for up to 52 weeks. The reported data shows that, for the primary question, 56.7% of participants taking 4 mg baricitinib met the SRI-4 response criteria, compared with 45.9% in the placebo group. For the 2 mg dose (a secondary measure), 49.8% met the same criteria versus the same 45.9% placebo figure. On a separate measure called "low disease activity state," the reported figures were 25.7% (2 mg), 29.7% (4 mg), and 26.2% (placebo). For steroid reduction (cutting the steroid dose by at least 25% down to a low level), the reported percentages were 29.2% (2 mg), 34.0% (4 mg), and 30.8% (placebo). For self-reported worst pain (on a 0–10 scale, where lower is better), average scores dropped by 1.73 points (2 mg), 1.71 points (4 mg), and 1.62 points (placebo) from the start of the trial. The data for "time to first severe flare" 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.

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NCT02794285 · results posted 13 January 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT02794285) was a long-term extension study involving people with systemic lupus erythematosus (lupus) who had previously taken part in related trials of a medicine called anifrolumab. A total of 547 participants were enrolled across four groups, depending on what they had received previously and what they were given during this extension phase. The trial was primarily measuring how often certain pre-specified medical events occurred across the groups over time, including serious infections, certain types of cancer, shingles, and major heart events, as well as serious adverse events (that is, significant medical events that required hospitalisation or were life-threatening, among other criteria). The reported data shows these event rates expressed as the number of events per 100 participant-years (a way of accounting for the fact that different people were in the study for different lengths of time). For the pre-specified events of special interest, the reported rates were: 11.0 for the group that received anifrolumab 300 mg throughout; 9.6 for the group that received placebo throughout; 12.9 for the group that switched from placebo to anifrolumab 300 mg; and 12.5 for the group that had previously received a lower dose (150 mg) and then continued on 300 mg. For serious adverse events, the reported rates were: 8.5, 11.2, 10.1, and 10.7 respectively across those same 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.

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NCT03597464 · results posted 14 December 2022

According to the results reported on ClinicalTrials.gov, this trial (AURORA 2) enrolled 216 people with lupus nephritis (a form of kidney inflammation linked to the autoimmune condition lupus). Participants had already completed an earlier trial (AURORA 1) and continued for up to a further 24 months. Of the 216 people who started, 116 were in the voclosporin group and 100 received a placebo (a dummy capsule with no active ingredient). By the end, 101 people in the voclosporin group and 85 in the placebo group completed the study. The trial was primarily measuring the number of side effects and changes in routine blood and urine tests over the longer follow-up period, and secondarily looking at kidney response rates and disease activity scores. The reported data shows that, for the primary measure of side effects, 100 out of 116 participants in the voclosporin group and 80 out of 100 in the placebo group experienced at least one adverse event (an unwanted health event that occurred during the study). For the kidney response measures, the reported numbers of participants meeting the full kidney response criteria at various time points ranged from 59 to 74 in the voclosporin group and 34 to 46 in the placebo group. For partial kidney response (defined as a 50% reduction in a specific urine protein measurement), the numbers ranged from 85 to 104 in the voclosporin group and 58 to 70 in the placebo group across the different time points. The reported data also shows that 39 people in the voclosporin group and 46 in the placebo group experienced a kidney flare (a return or worsening of kidney inflammation) during the study. For the disease activity score (a standardised scale used to measure lupus activity, where higher numbers mean more active disease), the reported data shows reductions from the original starting point of around 6.4 to 6.8 points in the voclosporin group and 5.6 to 6.1 points in the placebo group at various time points. For the urine protein-to-creatinine ratio (a measure of how much protein is leaking into the urine, where lower is generally considered better), the reported reductions from the starting point ranged from approximately 3.0 to 3.2 in the voclosporin group and 2.2 to 2.5 in the placebo group across the measured 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.

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NCT03616964 · results posted 23 November 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT03616964) enrolled 778 people in total across three groups: 257 received a placebo (a dummy treatment with no active ingredient), 262 received a 2 mg daily dose of baricitinib, and 259 received a 4 mg daily dose of baricitinib. The trial was studying baricitinib as a potential treatment for systemic lupus erythematosus (lupus), an autoimmune condition. The main thing the trial set out to measure was how many participants in the 4 mg group achieved what researchers call an "SRI-4 response" — a combined score showing a meaningful reduction in lupus disease activity based on three different disease assessment tools. The reported data shows that for the primary measure, 47.1% of participants taking the 4 mg dose of baricitinib and 45.6% of those taking the placebo achieved an SRI-4 response. For the 2 mg dose (a secondary measure using the same response definition), the figures were 46.3% for baricitinib and 45.6% for placebo. The reported data also shows that around 23–25% of participants across all three groups reached a state of "low disease activity" as defined by the trial. For the measure of steroid dose reduction, roughly 30–34% of eligible participants in each group met that target, with figures of 31.7% (placebo), 29.8% (2 mg), and 34.3% (4 mg). On the pain scale (0–10, where higher means more pain), all three groups reported a reduction from their starting scores: approximately −1.37 for placebo, −1.45 for 2 mg, and −1.44 for 4 mg. The data on time to first severe flare 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.

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NCT03093402 · results posted 18 November 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT03093402) tested a drug called JBT-101 across three different dose levels — a high dose, a medium dose, and a low dose — compared against a placebo (an inactive treatment). A total of 109 people started the trial across the four groups, and 91 people completed it. The main thing the trial was measuring was how much participants' pain scores changed over 84 days (about 12 weeks), using a standard 0–10 pain rating scale where 0 means no pain and 10 means the worst pain imaginable. The reported data shows that at the start of the trial, average pain scores across all four groups were similar, sitting between 6.0 and 6.4 out of 10 — which falls in the moderate-to-severe range. By Day 84, the reported average scores had shifted to 5.1 in the high-dose group, 4.9 in the medium-dose group, 5.1 in the low-dose group, and 5.9 in the placebo group. For the secondary outcomes, the trial also tracked how many people in each group fell into the "no pain," "mild pain," "moderate pain," or "severe pain" categories at several points across the study. The reported data shows that at most time points, the majority of participants in all groups — including the placebo group — were still reporting moderate to severe pain levels. Counts for those reporting no pain or mild pain were generally small across all groups at all visits. Some figures for certain sub-categories were not broken down fully 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.

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NCT03943147 · results posted 17 October 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT03943147) looked at a combination of two medicines — mycophenolate mofetil (MMF) and an investigational drug called BMS-986165 — in people with lupus nephritis, a condition where lupus causes kidney inflammation. The trial ran in two parts: an open-label run-in phase (Part A, where everyone received MMF alone) and a blinded treatment phase (Part B, where a small number of participants also received BMS-986165). In total, 16 participants started Part A, but only 6 completed it. Of those, just 1 participant ended up in the MMF plus BMS-986165 group in Part B, and that single participant completed Part B. Because so few people progressed through the trial, the numbers reported are based on very small groups. The reported data shows the following results for the one participant who received the combination treatment in Part B. On the primary outcomes: 1 out of 1 participant experienced an adverse event (an unexpected or worsening medical occurrence during the study); 0 out of 1 had clinically significant abnormal heart-tracing (ECG) results; and 0 out of 1 had clinically significant abnormal blood or urine lab results. Vital signs (blood pressure, heart rate, breathing rate, and temperature) showed percentage changes from their starting values ranging from roughly −3.5% to +16.9%, though the specific vital sign each figure belongs to was not individually labelled in the reported data. The reported data also shows that the level of protein relative to creatinine in a 24-hour urine sample — a marker used to assess kidney function — changed by approximately −34.9% from the starting point to week 24. On the secondary outcome, 0 out of 1 participants met the definition of a "partial renal response," which was set as a 50% or greater reduction in that same urine protein measure. It is important to note that because only one participant completed the combination-treatment phase, these numbers reflect the experience of a single person and cannot be used to draw broader conclusions. The trial appears to have stopped well short of its intended enrolment, and the reasons for participants not completing the study were not detailed 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.

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NCT03252587 · results posted 10 September 2022

According to the results reported on ClinicalTrials.gov, this trial tested a medicine called BMS-986165 (at three different doses: 3 mg, 6 mg, and 12 mg daily) compared to a dummy pill (placebo) in people with systemic lupus erythematosus (lupus). A total of 363 people took part — 90 in the placebo group, 91 in the 3 mg group, 93 in the 6 mg group, and 89 in the 12 mg group. The main thing the trial was measuring was how many people met a standard set of criteria showing their lupus had improved by week 32. This is called the SRI(4) score, which combines three separate assessments of disease activity rated by both the patient and their doctor. The reported data shows that at week 32 (the main measurement point), 31 out of 90 people in the placebo group met the improvement criteria, compared with 53 out of 91 in the 3 mg group, 46 out of 93 in the 6 mg group, and 40 out of 89 in the 12 mg group. The reported data also shows similar patterns at week 48, where the numbers were 31 (placebo), 52 (3 mg), 44 (6 mg), and 42 (12 mg). For other measures — including a different lupus improvement score (BICLA), a "low disease activity" rating, and a skin-specific score in people who had significant skin involvement at the start — the reported numbers were also higher in the treatment groups compared to placebo. For joint counts (a measure of tender and swollen joints), all four groups reported reductions from their starting scores, with the changes being 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.

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NCT03385564 · results posted 13 July 2022

According to the results reported on ClinicalTrials.gov, this trial looked at a drug called BI 655064, tested at three different doses (120 mg, 180 mg, and 240 mg), compared against a placebo (an inactive treatment) in people with lupus nephritis — a condition where lupus causes kidney inflammation. A total of 69 people took part across all four groups. The main thing the trial was measuring was the proportion of participants who achieved what researchers called a "complete renal response" — meaning their urine protein levels dropped to a low level and their kidney function either stayed in the normal range or did not decline much — and who also had no kidney flare-ups (sudden worsening of kidney symptoms) over 52 weeks. The reported data shows that, for the primary outcome, the adjusted (statistically fine-tuned to account for differences between participants) percentages achieving a complete renal response without any kidney flares were: 51.8% in the 120 mg group, 48.2% in the 180 mg group, 59.5% in the 240 mg group, and 57.5% in the placebo group. For the secondary outcomes, when looking at a stricter definition of response confirmed at two separate time points, the reported figures were 42.9% (120 mg), 30.8% (180 mg), 50.0% (240 mg), and 52.0% (placebo). The proportion of participants who experienced at least one kidney flare during the 52 weeks was 0% in the 120 mg group, 21.4% in the 180 mg group, 0% in the 240 mg group, and 16.0% in the placebo group. For those who did have a flare, the reported average time to the first flare was 36 weeks in the 180 mg group and 37.5 weeks in the placebo group; this figure was not reported for the 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.

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NCT03517722 · results posted 9 March 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT03517722) enrolled 516 adults with systemic lupus erythematosus (lupus) — 208 in the placebo group and 308 in the ustekinumab group — during the main 52-week blinded phase, where neither participants nor researchers knew who was receiving which treatment. The trial was primarily measuring how many people in each group met a combined set of criteria called the SRI-4 response at 52 weeks — a scoring system that looks at changes in disease activity across multiple body systems, as assessed by doctors and standard lupus measurement tools. The reported data shows that for the main (primary) outcome at week 52, 43.9% of participants in the ustekinumab group met the SRI-4 response criteria, compared with 56.0% in the placebo group. For the secondary outcomes, the reported data shows: at week 24, 45.7% of the ustekinumab group and 56.0% of the placebo group met the SRI-4 criteria; the average time until a disease flare (a worsening episode) was reported as approximately 204 days in the ustekinumab group and approximately 200 days in the placebo group; around 64.7% of ustekinumab participants and 66.3% of placebo participants with inflamed joints at the start achieved a 50% improvement in joint inflammation by week 52; 44.3% of ustekinumab participants and 29.3% of placebo participants who were taking steroid tablets (glucocorticoids) at the start achieved a sustained reduction in their steroid dose by week 52; and 40.7% of ustekinumab participants and 55.9% of placebo participants with significant skin involvement at the start showed a 50% improvement in their skin score by week 52. 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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NCT02547922 · results posted 24 November 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT02547922) enrolled 147 people with active lupus nephritis — a form of kidney inflammation linked to the autoimmune condition lupus. Participants were divided into three groups: 46 received anifrolumab on a basic dosing schedule, 52 received anifrolumab on an intensified dosing schedule, and 49 received a placebo (an inactive treatment). All groups also received standard-of-care treatment. The trial ran for 52 weeks and primarily looked at changes in a urine test — the protein-to-creatinine ratio (UPCR) — which is a way of measuring how much protein is leaking into the urine, often a sign of kidney stress. A lower ratio compared to the starting point suggests improvement. The reported data shows that for the primary measurement — the ratio of the urine protein result at week 52 compared to the starting level — all groups showed a ratio below 1, meaning all groups had lower protein levels in their urine at week 52 than at the start. The basic anifrolumab group recorded a ratio of 0.326, the intensified anifrolumab group recorded 0.285, and the placebo group recorded 0.296. For the key secondary measure — the proportion of participants who met a defined "complete renal response" (a combined kidney-health target) — the reported data shows 16.3% in the basic anifrolumab group, 45.5% in the intensified anifrolumab group, and 31.1% in the placebo group reached this target. The trial also tracked adverse events (unwanted health occurrences during the study): 43 of 46 participants in the basic anifrolumab group, 47 of 52 in the intensified group, and 44 of 49 in the placebo group recorded at least one adverse event 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.

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NCT02618967 · results posted 15 October 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT02618967) tested a drug called AMG 570 in 56 people in total. Participants were divided into eight groups: seven groups of 6 people each received different amounts of AMG 570 (ranging from 7 mg up to 700 mg), and a separate group of 14 people received a placebo (a dummy treatment with no active drug). The trial was measuring things like unwanted health events (called adverse events), changes in physical check-ups, blood pressure and heart rate, blood and urine test results, and heart tracing (ECG) readings. It also tracked how much of the drug was detected in participants' blood after dosing. The reported data shows that when it came to unwanted health events after receiving the treatment, the numbers who experienced at least one such event were: 6 out of 6 in the 7 mg group, 5 out of 6 in the 21 mg group, 4 out of 6 in the 70 mg group, 4 out of 6 in the 140 mg group, 2 out of 6 in the 210 mg group, 3 out of 6 in the 420 mg group, 4 out of 6 in the 700 mg group, and 9 out of 14 in the placebo group. The reported data also shows that no participants in any of the AMG 570 groups had clinically significant changes recorded in their physical check-ups, vital signs (such as blood pressure or heart rate), or heart tracings. For blood and urine lab tests, no clinically significant changes were reported in any AMG 570 group, though 3 out of 14 people in the placebo group did have such changes recorded. For the secondary measurements, the reported data shows that the peak level of AMG 570 detected in the blood rose with higher doses — from approximately 0.087 µg/mL (micrograms per millilitre, a measure of how much drug was in the blood) at the lowest 7 mg dose, up to approximately 58.5 µg/mL at the highest 700 mg dose. No blood-level data was reported for the placebo group, as participants in that group received no active drug. 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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NCT02770170 · results posted 12 July 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 121 adults across four groups to test three different doses of an investigational medicine called BI 655064 (120 mg, 180 mg, and 240 mg) compared to a placebo (an inactive treatment). The trial was measuring how well participants' kidneys responded over one year, specifically by looking at the amount of protein leaking into the urine and how well the kidneys were filtering — both key signs tracked in kidney disease. Of the 121 people who started, 99 completed the full study period. The reported data shows that for the main outcome — the proportion of participants achieving a "complete renal response" (very low protein in urine and stable kidney filtering) at the 52-week mark — the figures were: 38.3% in the 120 mg group, 45.0% in the 180 mg group, 44.6% in the 240 mg group, and 48.3% in the placebo group. For the secondary outcomes at 26 weeks, the reported complete renal response rates were 28.6% (120 mg), 50.0% (180 mg), 35.0% (240 mg), and 37.5% (placebo). The reported data also shows that at 52 weeks, between roughly 33% and 65% of participants across all groups (including placebo) met the definition of a "partial renal response" — meaning at least a 50% reduction in protein leaking into the urine — with the 180 mg group showing the highest rate at 65.0% compared to 60.0% 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.

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NCT03021499 · results posted 16 June 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03021499) enrolled 357 people with lupus nephritis (a kidney condition linked to lupus) — 179 received a medicine called voclosporin and 178 received a placebo (a dummy treatment with no active ingredient). The trial ran for 52 weeks and was primarily measuring how many participants met a specific definition of "kidney response" by the end of the study. That response was based on a combination of factors: a urine protein test result falling to a certain level, kidney function remaining stable, and participants not needing extra medicines to control their condition. The reported data shows that, for the main outcome at 52 weeks, 73 out of 179 participants in the voclosporin group met the kidney response criteria, compared with 40 out of 178 in the placebo group. For the secondary outcomes, the reported data shows that at 24 weeks, 58 people in the voclosporin group met the kidney response criteria compared with 35 in the placebo group. Regarding the urine protein test on its own (reaching a specific low level), 116 people in the voclosporin group achieved this compared with 78 in the placebo group. The reported data also shows that the median time for participants to reach that urine protein level was reported as 169 days in the voclosporin group and 372 days in the placebo group. For a less strict measure — halving the urine protein level from where it started — 126 voclosporin participants met this at week 24 and 125 at week 52, compared with 89 and 92 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.

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NCT02949973 · results posted 19 March 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT02949973) enrolled 10 people who all received the same treatment: voclosporin (23.7 mg twice daily) taken alongside standard care. Nine of the 10 participants completed the trial, and one did not. The trial was measuring changes in certain blood and urine markers linked to lupus nephritis — a kidney condition associated with lupus — as well as whether participants reached what researchers defined as "complete remission" at two time points. The reported data shows the following for the primary outcomes, which looked at whether key markers improved or returned to normal levels: 7 out of 10 participants showed a reduction or normalisation in their urine protein-to-creatinine ratio (a measure of how much protein is leaking into the urine, which can indicate kidney stress); 4 out of 10 showed a reduction or normalisation in an antibody called anti-dsDNA (often elevated in lupus); and 2 out of 10 showed a reduction or normalisation in each of two proteins called C3 and C4 (which are part of the immune system and can be low when lupus is active). For the secondary outcomes, the reported data shows that 7 out of 10 participants met the criteria for complete remission at week 24, and 4 out of the participants with sufficient data met those criteria at week 48 — noting that 2 participants did not provide enough data to assess their week 48 response. It is worth noting this was a very small, single-group trial with no comparison group, and the results reflect only this specific group of 10 people under the conditions of 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.

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NCT03407482 · results posted 19 December 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 160 people, all of whom received a drug called GDC-0853 (taken as a 200 mg dose twice daily). The trial was studying the drug as a potential treatment for systemic lupus erythematosus (lupus), an autoimmune condition. Of the 160 people who started, 29 completed the trial and 131 did not finish. The main thing the trial set out to measure was how many participants experienced any unwanted medical events (called "adverse events") while taking the drug. The reported data shows that 64.4% of participants — meaning roughly 6 in every 10 people in the trial — experienced at least one adverse event. It is important to note that an adverse event, as defined in this trial, is any unwanted or unexpected medical occurrence that happens while someone is taking a drug, and does not necessarily mean the drug caused it. For the secondary outcome measures — which included a lupus disease activity score (SRI-4) and several measures of how the drug moved through the body — no numerical results were reported in the data submitted to ClinicalTrials.gov. Because most participants did not complete the trial and several outcome measures have no reported numbers, the picture from this data is incomplete. 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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NCT01781611 · results posted 25 November 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 18 people in total — 13 in the group receiving extended release dipyridamole/aspirin and 5 in the group receiving aspirin alone. The trial was measuring disease activity in people with lupus, using a set of established scoring tools to track whether participants' lupus activity improved, stayed the same, or got worse over the course of the study. Of the 13 people in the dipyridamole/aspirin group, 4 did not complete the study, while all 5 participants in the aspirin group completed it. The reported data shows the following numbers for the main (primary) outcome — a measure called BICLA, which looks at whether lupus disease activity improved across multiple body systems without getting worse elsewhere: 3 out of 13 participants in the dipyridamole/aspirin group and 2 out of 5 in the aspirin group met this response standard. For the first secondary outcome (a similar but slightly different disease activity measure called SRI-4), the reported numbers were the same — 3 out of 13 in the dipyridamole/aspirin group and 2 out of 5 in the aspirin group. For the second secondary outcome, which looked at just one part of that measure (a meaningful drop in a lupus activity score called SLEDAI), the reported data shows 4 out of 13 participants in the dipyridamole/aspirin group and 2 out of 5 in the aspirin group met this threshold. It is worth noting that this was a very small trial, and the numbers above are raw counts of participants rather than a definitive comparison between the two 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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NCT02953821 · results posted 20 August 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 172 people with lupus (systemic lupus erythematosus) — 86 in a placebo gel group and 86 in an Acthar Gel group. The trial was measuring disease activity using several different scoring tools, each of which rates how active or severe a person's lupus appears to be, with higher scores generally meaning more disease activity. Most participants completed the study, with 71 in the placebo group and 73 in the Acthar Gel group finishing all the way through. The reported data shows that on the main disease activity measures, both groups started at similar levels and both showed lower scores over time. On the doctor's global assessment scale (a 0–100 scale where higher means more severe), the placebo group started at 58.8 and the Acthar Gel group at 60.6; by the final time point both had come down, to 26.9 and 25.5 respectively. On another disease activity score (BILAG-2004, ranging 0–108), both groups started around 18 and both fell to around 7–8 by the end of the study. For a third measure counting the number of participants who improved by at least 4 points on a separate lupus activity score (SLEDAI-2K), the reported data shows 40 placebo participants and 41 Acthar Gel participants met that threshold at one time point, and 46 versus 44 at another. For the secondary measures — including skin disease scores, swollen or tender joint counts, and severe flare episodes — the reported data shows both groups trended toward lower numbers over time, with the Acthar Gel group recording zero severe flares compared to three in the placebo group at 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.

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NCT02908100 · results posted 7 July 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 260 people with systemic lupus erythematosus (lupus) — 86 received a placebo (a dummy treatment), 87 received a lower dose of the investigational medicine GDC-0853 (150 mg once daily), and 87 received a higher dose (200 mg twice daily). The trial ran for 48 weeks and was primarily measuring how many participants met a standard lupus disease-activity response target called the SRI-4 — a combined score that looks at changes in disease activity, new flares in specific body systems, and the doctor's overall assessment of the patient's condition — by the end of the study. The reported data shows that at week 48, 44.2% of placebo participants, 50.6% of those on the lower dose, and 51.7% of those on the higher dose met the SRI-4 response target. For the secondary outcomes, the reported data shows similar patterns across other timepoints and sub-groups. At week 24, SRI-4 response rates were 46.5% (placebo), 52.9% (lower dose), and 52.9% (higher dose). When the measure also required participants to have reduced their steroid (oral corticosteroid) dose to below a certain threshold, the rates at week 48 were 41.9% (placebo), 50.6% (lower dose), and 44.8% (higher dose). The trial also looked at whether a particular blood marker called the "plasmablast signature" — a pattern in blood genes linked to a part of the immune system the medicine targets — was associated with different response rates, though the reported numbers across the four sub-groups within that analysis varied without a clearly consistent pattern. 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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NCT01597622 · results posted 9 January 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 142 people with systemic lupus erythematosus (lupus) who all received an open-label treatment called belimumab, given at a dose of 10 mg/kg. "Open-label" means everyone knew which treatment they were receiving. Of the 142 who started, 104 completed the study and 38 did not finish. The trial was measuring two main things: how many participants experienced unwanted medical events (called adverse events) during treatment, and how many showed a meaningful improvement in their lupus disease activity over time using a combined scoring tool called the SRI (SLE Responder Index). The reported data shows that, for the primary measure — tracking unwanted medical events — 139 out of 142 participants experienced at least one adverse event of any kind, and 48 out of 142 experienced a serious adverse event (meaning an event that was life-threatening, required hospitalisation, or was otherwise considered medically significant). These numbers describe what was recorded and counted during the study period; they do not indicate whether these events were caused by the treatment. For the secondary measure, the reported data shows the percentage of participants meeting the SRI response criteria (a combined score reflecting reduced lupus activity) at various points throughout the study. These percentages ranged from approximately 47.8% at the earliest timepoint up to a high of around 76.7% at one later visit, with most other timepoints falling somewhere between 51% and 68%. The data was reported across 12 separate study visits in total. It is worth noting that there was no comparison group in this study, so these figures reflect the single treatment group 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.

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NCT02446912 · results posted 5 December 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 457 adults with systemic lupus erythematosus (lupus) across three groups: 93 received anifrolumab at a lower dose (150 mg), 180 received it at a higher dose (300 mg), and 184 received a placebo (an inactive treatment). The trial ran for 52 weeks and was primarily measuring how many participants reached a defined level of improvement in their lupus — a combined score called the SLE Responder Index-4, or SRI(4), which takes into account changes in disease activity as judged by both the participant's doctor and a standardised scoring system. The reported data shows that for the main (primary) outcome — the number of participants meeting the SRI(4) response at 52 weeks under the original rules — 35 out of 93 participants in the lower-dose anifrolumab group, 65 out of 180 in the higher-dose group, and 74 out of 184 in the placebo group met the criteria. The trial team also ran a later (post-hoc) re-analysis using revised rules, which reported 45, 84, and 79 participants respectively meeting the same criteria. For a secondary outcome looking at a specific sub-group of participants whose blood tests showed high levels of a certain immune signal (interferon), the reported data shows 30, 53, and 59 participants meeting the response criteria under the original rules. A further secondary outcome tracked how many participants who were taking relatively high steroid doses at the start managed to reduce and sustain a lower steroid dose by weeks 40–52: the reported data shows 17, 42, and 33 participants achieving this under the original rules, and 24, 50, and 33 under the revised rules. 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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NCT01705977 · results posted 29 November 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled approximately 4,019 people in total — around 2,009 in the placebo group and 2,010 in the belimumab (10 mg/kg) group. The trial was measuring the number of deaths, serious medical events (called serious adverse events, or SAEs — meaning unplanned medical occurrences serious enough to cause hospitalisation, be life-threatening, or cause lasting harm), and a set of specific health events the researchers had nominated to watch closely (such as serious infections, certain cancers, mood-related events, and severe reactions to the infusion). These were tracked mainly over the first 52 weeks while participants were actively receiving their assigned treatment. The reported data shows that during the active treatment period (up to Week 52), 8 deaths were recorded in the placebo group and 10 in the belimumab group. Serious adverse events were reported by 222 participants in the placebo group and 220 in the belimumab group. For the closely watched specific events, the reported data shows: serious infections occurred in 82 placebo and 75 belimumab participants; other infections of interest in 50 versus 36; non-melanoma skin cancers in 5 versus 5; other cancers in 3 versus 4; serious mood or psychiatric events in 1 versus 7; and serious infusion or hypersensitivity reactions in 23 versus 28. When a broader counting window was used — covering the full study follow-up period including time after treatment stopped — the reported data shows 22 deaths in the placebo group and 13 in the belimumab group, and SAEs in 241 versus 233 participants respectively. The numbers for the specific watched events were broadly similar to the on-treatment figures. These figures describe what was counted and recorded; they do not on their own tell us why differences occurred or what caused them. 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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NCT02162992 · results posted 28 October 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 151 people with systemic lupus erythematosus (SLE, an autoimmune disease). Participants were divided into two groups based on a blood protein called an Anti-Ro antibody: 51 people who had this antibody and 100 people who did not. The trial was measuring electrical activity in the heart — specifically, how signals travel through the heart — to see whether having the Anti-Ro antibody was linked to any differences in those readings. Most participants completed the study (46 out of 51 in the antibody-positive group, and 99 out of 100 in the antibody-negative group). The reported data shows that the primary outcome looked at two heart-signal timing measurements taken from ECG recordings. The first, called the PR interval (the time it takes for an electrical signal to travel from the upper to the lower chambers of the heart), was reported as 89.22 milliseconds in the Anti-Ro antibody group and 91.41 milliseconds in the group without the antibody. The second measurement, called QRS duration (the time the lower chambers take to contract), was 145.68 milliseconds in the antibody-positive group and 146.72 milliseconds in the antibody-negative group. For the secondary outcome, a measurement called the corrected QT interval — which reflects how long it takes the heart to "recharge" between beats, adjusted for heart rate — was reported as 420.74 milliseconds in the antibody-positive group and 421.33 milliseconds in the antibody-negative group. An additional figure described as 8.25 (antibody-positive group) and 6.81 (antibody-negative group) was also listed under this outcome, though the specific label for what this number represents was 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.

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NCT02260934 · results posted 8 April 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 43 people in total — 22 in one group who received two medicines (rituximab and cyclophosphamide, referred to as RC) and 21 in a second group who received those same two medicines plus a third called belimumab (referred to as RCB). The trial was looking at serious infections, kidney-related responses, and certain changes in the immune system over roughly two years (at the 24-week, 48-week, and 96-week marks). By the end of the study, 19 people in the RC group and 17 in the RCB group had completed the trial. The reported data shows that the main thing the trial measured was the proportion of participants who experienced at least one serious infection (graded as severe or higher) during the study. In the RC group, 9.1% had such an infection by week 24, rising to 22.7% by week 48 and 27.3% by week 96. In the RCB group, the figures were 4.8% at week 24, 9.5% at week 48, and 9.5% at week 96. For the secondary measures, the reported data shows that kidney function response rates (called "overall response") in the RC group were 46.7%, 60.0%, and 53.3% at weeks 24, 48, and 96 respectively, compared with 55.0%, 73.7%, and 71.4% in the RCB group. A stricter measure called "complete response" showed rates of 23.8%, 35.0%, and 33.3% for RC, and 30.0%, 42.1%, and 42.9% for RCB across those same time points. A "sustained complete response" — meaning the strict criteria were met at both week 48 and week 96 — was reported for 26.7% of the RC group and 28.6% of the RCB group. The reported data also shows that no participants in either group experienced a very severe drop in a particular immune protein (IgG) at any time point, and that the proportion of participants whose immune B-cells returned to normal levels was generally lower in the RCB group than the RC group throughout 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.

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NCT01559090 · results posted 13 March 2019

According to the results reported on ClinicalTrials.gov, this trial tested a medicine called MEDI-546, given through a drip into a vein (intravenously), in three different dose groups: 100 mg, 300 mg, and 1,000 mg. A total of 17 people started the first stage of the trial (6, 5, and 6 in each dose group respectively), and a smaller number went on to complete a second stage. The trial was primarily measuring what side effects or unwanted events participants experienced, and secondarily measuring how the medicine moved through the body (called pharmacokinetics) and whether the body produced its own antibodies against the medicine. The reported data shows that across all three dose groups, every participant who enrolled experienced at least one adverse event (an unwanted or unexpected health occurrence) — that was 6 out of 6 in the 100 mg group, 5 out of 5 in the 300 mg group, and 6 out of 6 in the 1,000 mg group. One participant in each group experienced a serious adverse event. No participants in any group discontinued the trial due to an adverse event, though 2, 2, and 3 participants respectively did not complete Stage I for reasons the data does not break down further. For the body's processing of the medicine, higher doses were associated with higher measured levels in the blood — the reported peak blood concentration (the highest level reached) was 41.1 micrograms per millilitre in the 100 mg group, 75.1 in the 300 mg group, and 254.8 in the 1,000 mg group. The reported data also shows that in each dose group, 1 participant developed antibodies against the medicine itself (known as anti-drug antibodies), while 5, 4, and 5 participants respectively did not. These numbers describe only what was measured and counted in this small trial, and no conclusions about broader populations should be drawn from them. 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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NCT02265744 · results posted 4 January 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02265744) tested an investigational drug called BMS-931699 (given as an injection under the skin) in people with systemic lupus erythematosus (lupus). A total of 346 people were enrolled across five groups: four groups received different doses or schedules of BMS-931699, and one group received a placebo (an inactive injection). The trial was primarily measuring how many participants met a specific set of criteria — called a BICLA response — that indicated improvement in their lupus disease activity by around day 169 (roughly 24 weeks). Numbers who completed the study ranged from 47 to 58 people per group, out of the 68–71 who started in each group. The reported data shows that, for the primary outcome at day 169, the percentage of participants who met the BICLA response criteria was: 59.4% in the 12.5 mg weekly group, 63.2% in the 12.5 mg every-other-week group, 57.4% in the 5 mg every-other-week group, 58.6% in the 1.25 mg every-other-week group, and 59.2% in the placebo group. For the secondary outcomes, the reported data shows response rates on a related disease-activity measure (SRI-4) at day 169 ranged from approximately 39.7% to 55.1% across the BMS-931699 groups, compared with 49.3% in the placebo group. Scores on a skin-involvement scale (CLASI, where higher numbers mean more disease activity) showed small decreases from the starting point across all groups, including the placebo group, and the data was not fully reported for all groups on some of the more detailed secondary measures. 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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NCT02708095 · results posted 21 November 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT02708095) enrolled 314 adults with systemic lupus erythematosus (lupus) — a condition where the immune system attacks the body's own tissues. Participants were split into three groups: 105 received a placebo (a dummy treatment with no active ingredient), 105 received a 2 mg daily dose of baricitinib, and 104 received a 4 mg daily dose of baricitinib. The trial's main goal was to measure how many people in each group saw their joint pain (arthritis) and/or skin rash — two common lupus symptoms — go away after 24 weeks. By the end of the study, 83 placebo participants, 86 in the 2 mg group, and 86 in the 4 mg group had completed the trial. The reported data shows that, for the main outcome at 24 weeks, 53.3% of the placebo group, 58.1% of the 2 mg baricitinib group, and 67.3% of the 4 mg baricitinib group met the target of having their arthritis and/or rash go away. For a broader measure of overall disease activity (called SRI-4, which combines several different disease assessments into one score), the reported figures were 47.6% for placebo, 51.4% for the 2 mg group, and 64.4% for the 4 mg group. On a disease activity scoring scale (where higher numbers mean more active disease), all three groups showed a reduction from their starting scores: the placebo group dropped by about 3.82 points on average, the 2 mg group by about 4.07 points, and the 4 mg group by about 4.39 points. The reported data also shows that patients' own ratings of their disease activity (on a 0–4 scale) decreased across all groups: by 0.67 points on average in the placebo group, 0.83 points in the 2 mg group, and 1.00 point in the 4 mg group. The trial also measured how much of the drug was present in participants' blood over time, which the researchers used to understand how the body processes baricitinib — those figures were reported for the two baricitinib groups only, and no equivalent measurement applies to 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.

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NCT01031836 · results posted 19 November 2018

According to the results reported on ClinicalTrials.gov, this trial tested a medicine called MEDI-545 (also known as sifalimumab) in people with lupus. The trial was run in two stages. In Stage I, 5 people were enrolled into each of six different dosing groups — four given the medicine through a drip into a vein (intravenous, or IV) at different dose levels (1.0, 3.0, or 10.0 mg per kilogram of body weight, or a flat 600 mg or 1,200 mg dose), and one group given it as an injection under the skin (subcutaneous, or SC) at 100 mg — making 30 participants in total for Stage I. Fewer participants went on to complete Stage II. The trial was measuring how the body processed the medicine at different doses, how it affected certain immune system activity, and how many participants experienced adverse events (unwanted health events recorded during the trial). The reported data shows that for the primary outcome — tracking adverse events in Stage I — all 5 participants in most dose groups had at least one adverse event recorded. Serious adverse events (a more severe category) were reported in 3 out of 5 participants in the 3.0 mg/kg IV group, 2 out of 5 in the 10.0 mg/kg IV group, and 1 out of 5 in the 1,200 mg IV group, with none recorded in the remaining three groups. For the secondary outcomes, the reported data shows that higher doses generally corresponded to higher measured drug levels in the blood. A change in a 21-gene marker (a laboratory measure of immune system signalling activity) was reported as a decrease across all groups after dosing. Two participants — one in the 3.0 mg/kg IV group and one in the 1,200 mg IV group — developed antibodies against the medicine itself, which was also tracked as a secondary outcome. 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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NCT01408576 · results posted 3 October 2018

According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called epratuzumab, given to people with lupus (a disease where the immune system attacks the body). A total of 1,250 participants were enrolled across three groups, receiving either epratuzumab at 600 mg per week or 1,200 mg every two weeks, over a treatment period of up to 96 weeks (about two years). The trial was primarily measuring how many participants stopped taking the medicine early because of an unwanted medical event (called a treatment-emergent adverse event, or TEAE), and how many experienced a serious adverse event (SAE) — meaning a medical event considered serious enough to require hospitalisation or other significant intervention. A secondary measure looked at how many participants met a combined set of criteria suggesting their lupus activity had improved. The reported data shows that across all participants, 96 out of 1,250 (about 7.7%) stopped treatment early due to a TEAE. When broken down by group, this was approximately 10.7% in the Cohort 1 group receiving 600 mg per week, 9.1% in the Cohort 2 group receiving 1,200 mg every two weeks, and 4.9% in the Cohort 2 group receiving 600 mg per week. Regarding serious adverse events, the reported data shows that 304 out of all participants (about 24.4%) experienced at least one SAE during the treatment period. For the secondary outcome — meeting the combined response criteria for lupus activity — 362 out of all participants (approximately 29.9%) were reported as meeting those criteria. It is worth noting that the vast majority of participants did not complete the overall study period, and completion data was only recorded for one of the three 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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NCT01262365 · results posted 29 June 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT01262365) enrolled 793 adults with lupus across three groups: 266 received a placebo (inactive treatment given as weekly infusions), 262 received epratuzumab at a dose of 1,200 mg every other week, and 265 received epratuzumab at 600 mg per week. The trial was measuring how many participants met a combined set of response criteria — based on disease activity scores rated by doctors, and whether participants' other medications remained stable — at several points over 48 weeks. The reported data shows that at the main measurement point of 48 weeks, 34.1% of participants in the placebo group met the combined response criteria, compared with 39.8% in the 1,200 mg every-other-week group and 37.5% in the 600 mg per week group. At earlier time points, the reported figures were: at 12 weeks — 31.3% (placebo), 42.2% (1,200 mg), and 39.9% (600 mg); at 24 weeks — 33.7% (placebo), 43.0% (1,200 mg), and 39.1% (600 mg); and at 36 weeks — 33.3% (placebo), 41.8% (1,200 mg), and 35.1% (600 mg). The trial also tracked whether participants' daily steroid (corticosteroid) doses changed over time, with results reported across several categories, though a full breakdown of those categories was not clearly labelled 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.

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NCT01205438 · results posted 19 June 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,124 people in total — 372 in the group receiving LY2127399 (tabalumab) every 2 weeks, 376 in the group receiving it every 4 weeks, and 376 in a placebo group. The trial was studying a medicine called LY2127399 in people with lupus (SLE), and the main thing it was measuring was whether participants met a combined set of criteria showing reduced disease activity at 52 weeks — known as the "SLE Responder Index." This involved looking at changes across several disease scoring tools used by doctors to track lupus activity. The reported data shows that at 52 weeks, 38.5% of participants in the every-2-weeks group, 34.8% in the every-4-weeks group, and 27.7% in the placebo group met the main response criteria. For one of the secondary measures — whether participants were able to reduce their steroid (prednisone) dose while keeping their disease quiet — the reported figures were 21.2%, 14.7%, and 11.5% respectively. The reported data also shows changes in a lab marker linked to lupus (anti-dsDNA): levels fell by an average of 27.7 and 26.4 units in the two treatment groups, compared with 7.0 units in the placebo group. A doctor's overall rating of disease activity (scored 0–100) was reported to have decreased by about 21.2 and 19.2 points in the treatment groups, versus 15.1 points in the placebo group. No figures were reported for the time-to-first-severe-flare outcome. 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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NCT02041091 · results posted 15 June 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 226 adults in total — 112 received the study drug tabalumab via a prefilled syringe, and 114 received the same drug via an auto-injector (a pen-style self-injection device). The trial was not testing whether the drug treated a condition better or worse depending on the device; instead, it was measuring how the drug behaved in the body — specifically, how much of the drug reached the bloodstream and how it was absorbed — to compare the two delivery methods with each other. The reported data shows that the main measurements were the peak drug level in the blood (called maximum concentration, or Cmax) and the total drug exposure over the first 14 days (called AUC, which is essentially a measure of how much drug was present over time). For the prefilled syringe group, the reported peak concentration was 35.7 micrograms per millilitre, and for the auto-injector group it was 34.1 micrograms per millilitre. The total drug exposure figures were 8,390 and 8,170 (in units of microgram-hours per millilitre) respectively. The reported data also shows that when results were broken down by body weight across all participants, people in the lower weight group (under 60 kg) had a higher reported peak level (47.8 µg/mL) compared to the medium weight group (34.7 µg/mL) and the higher weight group (over 100 kg, at 25.4 µg/mL), with similar patterns seen in total drug exposure. For the secondary measurements, the reported data shows that only 1 participant (in the auto-injector group) reported an incomplete dose being delivered, and only 1 participant (in the prefilled syringe group) developed antibodies against the drug — a process where the body's immune system recognises the drug as a foreign substance. 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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NCT01196091 · results posted 12 June 2018

According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called LY2127399 (also known as tabalumab) in people with systemic lupus erythematosus (lupus). A total of 1,164 people took part and were split into three groups: one group received LY2127399 every two weeks, another received it every four weeks, and a third group received a placebo (a dummy treatment with no active ingredient). The trial ran for 52 weeks and was mainly measuring how many participants met a combined set of criteria showing their lupus had improved — including reductions in disease activity scores — known as the "SLE Responder Index." The reported data shows that at 52 weeks, 31.8% of participants in the every-two-weeks group, 35.2% in the every-four-weeks group, and 29.3% in the placebo group met the main measure of response. For the secondary measures, around 15.5%, 17.0%, and 16.4% of participants in the three groups respectively (every two weeks, every four weeks, and placebo) were able to reduce their steroid dose while keeping their disease quiet. Changes in a lupus-related blood marker (anti-dsDNA) showed similar shifts across all three groups (roughly 107–110 units). Disease activity scores on another scale (SLEDAI-2K) decreased by around 4.7, 4.9, and 4.6 points in the three groups respectively. Around 64.3%, 61.4%, and 58.0% of participants in each group showed no worsening on the doctor's overall disease rating. Data on time to first severe lupus flare 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.

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NCT02349061 · results posted 12 June 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT02349061) looked at a medicine called ustekinumab in people with systemic lupus erythematosus (lupus), an autoimmune condition. In the first phase of the study (up to 24 weeks), 60 participants received ustekinumab and 42 received a placebo (a dummy treatment with no active ingredient). After 24 weeks, participants who had been on placebo were switched to ustekinumab, and the study continued through to week 56, with a further optional extension to week 120. The main thing researchers were measuring was a combined score called the SRI-4 response — a set of lupus disease activity tools used together to judge whether a participant's condition had improved by week 24. The reported data shows that, at week 24, about 61.7% of participants in the ustekinumab group met the SRI-4 response measure, compared with 33.3% in the placebo group. For the secondary measures, the reported data shows that disease activity scores (measured on a 0–105 scale, where higher means more active disease) fell by an average of 4.4 points in the ustekinumab group and 3.8 points in the placebo group. A doctor's rating of overall disease activity (on a 0–10 scale) fell by an average of 2.17 points in the ustekinumab group and 1.93 points in the placebo group. Regarding a separate response measure called BICLA (another combined lupus activity score), 21 out of 60 participants in the ustekinumab group met that measure compared with 14 out of 42 in the placebo group. Finally, among those who had at least two painful, inflamed joints at the start, the average number of affected joints fell by 4.5 in the ustekinumab group and 2.8 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.

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NCT01488708 · results posted 17 May 2018

According to the results reported on ClinicalTrials.gov, this trial looked at a drug called LY2127399 in people with Systemic Lupus Erythematosus (lupus), a condition where the immune system attacks the body's own tissues. Participants were split into two groups based on how often they received the drug: one group of 940 people received it every two weeks, and another group of 578 people received it every four weeks. The trial's main focus was on recording any unwanted or unexpected health events (called adverse events) that participants experienced during the study. The reported data shows that in the group receiving the drug every two weeks, 73.3% of participants experienced at least one adverse event. In the group receiving it every four weeks, 65.6% of participants experienced at least one adverse event. It is worth noting that the trial recorded zero participants as having formally "completed" the study in both groups, though the majority did participate in a follow-up phase. The trial also set out to measure several other things — including how well the drug might control lupus symptoms, whether steroid doses could be reduced, and whether quality of life improved — however, no numerical results for any of those secondary measures were included in the data 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.

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NCT01714817 · results posted 21 December 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT01714817) looked at a treatment called abatacept (given by drip into a vein) compared to a placebo (an inactive drip) in people with a kidney condition caused by lupus, known as lupus glomerulonephritis. A total of 203 people were assigned to each group — 203 receiving abatacept and 203 receiving placebo — at the start of the first year. The trial ran across several phases over a number of years, and by the end of the long-term extension, 62 people in the abatacept group and 53 in the placebo group had completed that final stage. The main thing the trial was measuring was whether participants achieved what was called a "complete renal response" — meaning their kidney function, urine protein levels, urine appearance, and steroid dose all met certain targets at one year. The reported data shows that at the one-year mark, about 35.1% of participants in the abatacept group and 33.5% in the placebo group met the criteria for a complete renal response. Among a subgroup of participants who had higher levels of protein in their urine at the start (called "nephrotic" participants), the reported figures were 27% for abatacept and 29.5% for placebo. The reported data also shows that average urine protein levels (a measure of kidney leakage) fell in both groups over the year — by about 3.0 units in the abatacept group and 2.9 units in the placebo group across all participants, and by about 5.0 and 4.8 units respectively in the nephrotic subgroup. A score measuring overall lupus disease activity also decreased in both groups over the year, with an average reduction of 8.22 points in the abatacept group and 7.60 points in the placebo group (on a scale where lower scores reflect less disease activity). Regarding reported unwanted events during the first year, the data shows that 188 out of 202 treated participants in the abatacept group and 194 out of 203 in the placebo group experienced at least one adverse event (an unwanted or unexpected experience during the trial). Serious adverse events were reported in 49 people in the abatacept group and 39 in the placebo group, and 10 people in the abatacept group and 9 in the placebo group stopped the study due to an adverse event. This summary does not interpret whether any of these numbers are large or small — it simply reflects what was recorded. 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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NCT01405196 · results posted 19 December 2017

According to the results reported on ClinicalTrials.gov, this trial tested an investigational medicine called PF-04236921 in people with Systemic Lupus Erythematosus (lupus), a long-term autoimmune condition. A total of 183 people took part across four groups: 45 received a 10 mg dose, 47 received a 50 mg dose, 46 received a 200 mg dose, and 45 received a placebo (a dummy treatment with no active ingredient). The main thing the trial was measuring was how many participants met a set of pre-defined criteria — combining scores from three different lupus disease-activity tools — to be classed as a "responder" at 24 weeks. Note that the 200 mg group was not included in the main responder analysis, only in some other measurements. The reported data shows that at 24 weeks, approximately 59.9% of participants in the 10 mg group, 39.2% in the 50 mg group, and 40.1% in the placebo group were classed as responders on the main measure. For the secondary measures, which tracked responder rates at earlier time points (weeks 4, 8, 12, 16, and 20), the reported percentages varied across all groups at each time point — for example, at week 16, the figures were approximately 48.9% (10 mg), 28.9% (50 mg), and 37.1% (placebo). Other secondary measures used slightly different scoring tools and similarly reported varying percentages across groups and time points. For the laboratory test results, small numbers of participants across groups had readings flagged as potentially clinically noteworthy — for example, 2 participants in the 10 mg group, and none in the other groups, had a particular liver enzyme reading in a pre-specified range of interest. It is worth noting that in several of the secondary measures, the placebo group's reported percentages were sometimes similar to or higher than those in the active treatment groups at certain time points — this is simply what the numbers show, and drawing conclusions from these figures requires careful medical interpretation. 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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NCT01484496 · results posted 25 July 2017

According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called belimumab (given as a subcutaneous injection, meaning injected under the skin) in people with lupus, an autoimmune condition. In the first part of the trial, 280 participants received a placebo (an inactive injection) and 556 received belimumab 200 mg. A number of participants from each group did not complete the first phase — 66 from the placebo group and 93 from the belimumab group. Those who finished the first part could then continue into a second open-label phase, where everyone received belimumab. The trial's main focus was whether participants showed a meaningful overall improvement in their lupus symptoms at 52 weeks, using a combined scoring system called the SRI (SLE Responder Index), which looks at disease activity, doctor assessments, and organ involvement together. The reported data shows that at 52 weeks, 61.4% of participants taking belimumab met the criteria for an SRI response, compared with 48.4% of those taking the placebo. For one of the secondary measures — the time until a participant experienced a severe lupus flare (a significant worsening of symptoms) — the reported figures show a median of 171 days in the belimumab group compared with 118 days in the placebo group. For the third measure, which looked at participants who were taking higher doses of the steroid prednisone at the start and whether their dose was reduced by at least 25% to a lower level (7.5 mg or less per day) between weeks 40 and 52, the reported data shows 18.2% of the belimumab group met this criterion compared with 11.9% in the placebo group. It is important to note that these numbers describe what was measured and recorded during this specific trial, under its particular conditions and in the people who took part. 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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NCT01582880 · results posted 24 July 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled just one participant, who completed the study. The trial was looking at a procedure involving a donor cornea (the clear front layer of the eye) that had been treated with a substance called riboflavin and then cross-linked (a process used to stiffen and strengthen corneal tissue). The main thing being measured was how the thickness of that donor cornea changed over the first year after surgery, using a type of eye-scanning technology. Thickness was measured at two distances from the central implant — 1 millimetre and 2 millimetres away — and readings were taken at weeks 4, 6, 26, 32, and 52. The reported data shows that at 1 millimetre from the implant, the average corneal thickness measurements across those five time points were 730, 760, 700, 720, and 680 micrometres (a micrometre is one-thousandth of a millimetre). At 2 millimetres from the implant, the reported measurements were 940, 860, 820, 795, and 780 micrometres. The reported data shows a general trend of the numbers changing across the time points, though with only one participant, these figures represent a single person's results only. The reported data also shows that the secondary outcomes — which counted the number of ulcers (sores on the eye), eye-related adverse events (unexpected medical occurrences), and body-wide adverse events — were all recorded as zero occurrences for this one participant 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.

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NCT01499355 · results posted 18 January 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 276 people in an initial run-in phase, of whom 245 moved forward. Those participants were then randomly placed into one of three groups for a double-blind period (meaning neither the participants nor the researchers knew who was receiving which treatment): 63 received a placebo (an inactive treatment), 63 received a lower dose of the investigational drug BIIB023 (3 mg/kg), and 62 received a higher dose of BIIB023 (20 mg/kg). The trial was measuring kidney response — specifically, whether participants' urine protein levels and kidney filtration improved over 52 weeks (about one year) according to pre-set definitions of "complete" or "partial" response. The reported data shows that, for the primary outcome — the percentage of participants achieving either a complete or partial kidney response at 52 weeks — 25% of the placebo group, 16% of the lower-dose BIIB023 group, and 31% of the higher-dose BIIB023 group met that threshold. For the secondary outcome of complete kidney response alone, the figures were 6% (placebo), 8% (lower dose), and 8% (higher dose). The reported data also shows that, among those who did achieve a kidney response, the estimated time to first reaching that response was approximately 10.6 weeks in the placebo group, 5.2 weeks in the lower-dose group, and 4.1 weeks in the higher-dose group. For a separate secondary measure looking at urine sediment activity, 38% of the placebo group, 5% of the lower-dose group, and 21% of the higher-dose group showed improvement from active to inactive sediment by week 52. 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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NCT01930890 · results posted 18 January 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT01930890) enrolled 87 people in total across four groups. All participants had previously taken part in an earlier related study and continued into this follow-on phase receiving either a lower dose (3 mg/kg) or a higher dose (20 mg/kg) of the investigational medicine BIIB023, or had switched to one of those doses after previously receiving a dummy treatment (placebo). The trial's main focus was on tracking and counting any unwanted medical events — called adverse events (AEs) — and any serious adverse events (SAEs), which are more severe medical occurrences such as hospitalisation or life-threatening events. The reported data shows that across the four groups, the number of participants who experienced any adverse event ranged from 4 out of 14 people in the placebo-then-lower-dose group, up to 23 out of 33 people in the group who received the lower dose throughout both studies. For serious adverse events, the numbers reported were 2, 12, 3, and 6 participants across the four groups respectively. Deaths were reported for 0, 4, 1, and 3 participants across the groups. Regarding people who stopped treatment or left the study because of an adverse event, the reported data shows that most groups recorded zero such participants, with 2 people in the ongoing lower-dose group and 1 person in the ongoing higher-dose group recorded as having done so. 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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NCT01345253 · results posted 2 December 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT01345253) enrolled 677 people with systemic lupus erythematosus (lupus) during the main double-blind phase — 226 received a placebo (a dummy treatment) and 451 received belimumab at a dose of 10 mg/kg. Neither the participants nor their doctors knew who was receiving which treatment during this phase, which lasted 52 weeks (about one year). After that, a longer open-label phase followed, in which participants could receive belimumab and both they and their doctors knew what was being given; 424 people entered this phase. The trial was primarily measuring what proportion of participants met a combined set of disease-activity criteria — known as the SLE Responder Index (SRI) — at the end of the 52-week blinded period. The reported data shows that for the main 52-week measurement, 40.1% of participants in the placebo group met the SRI response criteria, compared with 53.8% in the belimumab group. For one of the secondary measures — looking only at whether participants' lupus activity score (a numerical scale where higher means more active disease) dropped by at least 4 points — 42.2% of the placebo group and 55.7% of the belimumab group met that threshold. A stricter version of that measure (a drop of at least 7 points, plus no worsening on other scores) was met by 23.5% of the placebo group and 32.4% of the belimumab group. For the measure examining steroid dose reduction over 52 weeks, the reported values for both groups were 0.0 days, and for the time-to-first-severe-flare measure, numeric values were not reported in the submitted data. During the longer open-label phase, the reported SRI response rate among all participants receiving belimumab ranged from approximately 60% to 86% across the various time points measured, though the data was not reported separately by original treatment group at all 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.

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NCT01283139 · results posted 11 July 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 432 people with systemic lupus erythematosus (lupus) across four groups: 108 received a placebo (a dummy treatment with no active ingredient), 108 received a low dose of sifalimumab (200 mg), 109 received a medium dose (600 mg), and 107 received a high dose (1,200 mg). The trial was measuring whether sifalimumab, a drug that targets a part of the immune system, could reduce lupus disease activity compared to placebo. The main measure used was called the SRI(4) — a scoring system that combines several assessments to judge whether a participant's overall lupus activity had improved without getting worse in other areas. The reported data shows that, by the end of the study, 45.4% of placebo participants met the SRI(4) response criteria, compared with 58.3% in the 200 mg group, 56.5% in the 600 mg group, and 59.8% in the 1,200 mg group. In a subgroup of participants who had a specific biological marker (called "4-gene interferon test high"), the reported response rates were 42.0% for placebo, 57.5% for 200 mg, 50.0% for 600 mg, and 57.5% for 1,200 mg. For the secondary measures, the reported data shows that among participants who were on higher-dose steroid tablets at the start, roughly 6–9% across all groups managed to reduce their steroid dose to the target level by day 365. For skin-related lupus activity, between 48.6% (placebo) and 73.1% (1,200 mg) of eligible participants showed a meaningful improvement in their skin score. Regarding fatigue, between 30.5% (placebo) and 42.2% (600 mg) of participants reported a meaningful improvement on the fatigue questionnaire. The reported data also shows that the number of participants who experienced any adverse event (an unwanted medical occurrence during the trial) ranged from 93 to 97 across the four groups, and serious adverse events were recorded in 16 to 22 participants per group — though this data alone does not allow any conclusions about safety. 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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NCT00724867 · results posted 28 March 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 268 participants, all of whom received belimumab (10 mg/kg given by intravenous drip). Of those, 140 completed the study and 128 did not finish. The trial was a long-term extension study, and its primary focus was on monitoring and recording unwanted medical events (called adverse events, or AEs) and serious unwanted medical events (called serious adverse events, or SAEs), as well as tracking changes in certain blood test results over time. The reported data shows that across the different body systems monitored, the rate of adverse events ranged from roughly 9 to 134 events per 100 participant-years (a way of accounting for different lengths of time each person was in the study). The rate of serious adverse events was lower, ranging from about 0.5 to 4 events per 100 participant-years across the body systems measured. The reported data also shows small changes from starting levels in various blood measurements over time — including blood clotting times (measured in seconds) and counts of different blood cell types — with the numbers for most blood cell counts remaining very close to their starting values throughout the study. It is worth noting that because there was no comparison group in this study, the data does not include a direct comparison to a placebo or alternative 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.

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NCT00624338 · results posted 14 March 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 461 adults with lupus (systemic lupus erythematosus) across three groups: 159 people were assigned to atacicept 75 mg, 145 to atacicept 150 mg, and 157 to a placebo (a dummy treatment with no active ingredient). The trial was measuring whether atacicept reduced "flares" — periods when lupus symptoms became more active — over up to 52 weeks, using a recognised lupus scoring system called BILAG. It is worth noting that the 150 mg group had a notably higher number of people who did not complete the study (83 out of 145) compared to the other two groups. The reported data shows that, for the main outcome — the percentage of participants who experienced at least one lupus flare over the full study period — 57.3% of those in the atacicept 75 mg group had a flare, compared with 36.1% in the atacicept 150 mg group and 53.3% in the placebo group. For a related secondary measure looking at only the first 24 weeks, the reported figures were 40.1% (75 mg), 28.5% (150 mg), and 35.1% (placebo). The reported data also shows that the earliest point at which 25% of participants had experienced their first flare was around day 143 in the 75 mg group, day 310 in the 150 mg group, and day 142 in the placebo group (the midpoint was not reached in any group within the study timeframe). The mean total corticosteroid dose — a type of medication often used to manage lupus flares — was reported as approximately 2,457 mg for the 75 mg group, 2,019 mg for the 150 mg group, and 2,624 mg 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.

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NCT01393132 · results posted 23 December 2015

According to the results reported on ClinicalTrials.gov, this trial (NCT01393132) enrolled 9 people in total — 6 in the Thymosin group and 3 in the placebo group. All 9 participants completed the study. The trial was measuring a number of things related to dry eye, including eye safety, surface damage to the cornea (the clear front of the eye), how uncomfortable participants felt, and how long the tear film (the thin layer of moisture covering the eye) stayed intact before breaking up. The reported data shows that for the primary measure — safety, tracked by counting unwanted medical events (called adverse events) and monitoring eye pressure and overall eye health at several time points — zero adverse events were recorded in either the Thymosin group or the placebo group. For the secondary measures, the reported data shows the following numbers at day 56: on the Oxford Scale, which scores corneal surface damage from 0 (no damage across five regions) to 25 (most damage), the Thymosin group averaged 4.5 and the placebo group averaged 11.0. On the Ocular Surface Disease Index (OSDI), a questionnaire where higher scores out of 100 mean greater discomfort, the Thymosin group averaged 45.6 and the placebo group averaged 67.2. For tear film break-up time — how many seconds the tear film held together before breaking — the Thymosin group averaged 5.6 seconds and the placebo group averaged 2.8 seconds (note: the study states that under 5 seconds is considered low, with a high likelihood of dry eye symptoms). It is worth noting that this was a very small trial with only 9 participants, so the reported figures are based on a limited number of people. The data was not reported in a way that allows for broader conclusions to be drawn 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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NCT01709474 · results posted 3 December 2015

According to the results reported on ClinicalTrials.gov, this trial compared two different daily doses of Vitamin D3 — a higher dose of 6,000 IU and a lower dose of 400 IU — in a very small group of participants. In total, just 7 people took part: 3 in the higher-dose group and 4 in the lower-dose group. All 7 participants who started the trial completed it. The trial was originally designed to measure changes in certain immune-related biological markers (called IFN module expression levels) and to track any significant unwanted reactions (called adverse events, meaning unexpected health problems rated as moderately severe or worse). The reported data shows that, for the main biological measurement the trial set out to examine, no results were recorded. According to the results reported on ClinicalTrials.gov, this was because the trial was unable to recruit enough participants to carry out that part of the analysis. For the second primary measurement — tracking serious unwanted reactions — the reported data shows that 0% of participants in the 6,000 IU group experienced a significant adverse event, while 25% of participants in the 400 IU group (meaning 1 out of 4 people) did. No further detail about the nature of that event was included in the submitted data. It is worth noting that, with only 7 participants in total, this was an extremely small study, and the trial itself acknowledged it could not be completed as originally planned due to difficulties recruiting enough people. 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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NCT00425438 · results posted 25 September 2014

According to the results reported on ClinicalTrials.gov, this trial compared two treatment approaches for people with kidney disease — one group of 25 participants received Mycophenolate Mofetil, and another group of 27 participants received a combination of Cyclophosphamide and Azathioprine. The trial was measuring things like whether participants' urine protein levels and kidney function improved over the course of treatment, and how long it took for those changes to occur. The reported data shows that, unfortunately, no numerical results were submitted for any of the outcome measures — including the primary outcome (whether participants achieved a "complete response," meaning their urine protein dropped to a very low level with no signs of ongoing kidney inflammation) or any of the secondary outcomes (such as partial treatment response, changes in kidney filtration rate, or treatment failure events). The ClinicalTrials.gov record also shows that zero participants were recorded as having "completed" the study in either group, though the reasons for this are not explained in the data provided. Because no measurement data was reported for any outcome, it is not possible to describe what the trial found in terms of numbers. The reported data shows only that the trial enrolled 52 participants across the two groups, but the results themselves were not 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.

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NCT01127321 · results posted 26 August 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 17 people in total across five groups. Three participants received a placebo (an inactive substance), and the remaining 14 received different doses of an investigational medicine called MEDI-570 (at doses of 0.03 mg, 0.1 mg, 0.3 mg, or 1 mg — with 1, 1, 7, and 5 participants in each dose group respectively). All 17 participants completed the study. The trial was primarily measuring how many participants experienced unwanted medical events (called adverse events) after receiving the study drug, as well as tracking how the drug moved through the body and whether participants developed antibodies against it. The reported data shows that when it came to general unwanted medical events that emerged during the treatment period, all 3 placebo participants, the 1 participant in the 0.03 mg group, the 1 participant in the 0.1 mg group, all 7 in the 0.3 mg group, and 4 of the 5 in the 1 mg group experienced at least one such event. For more serious unwanted medical events — those involving hospitalisation, life-threatening situations, lasting disability, or death — the reported data shows 0 in the placebo group, 0 in the 0.03 mg group, 1 in the 0.1 mg group, 2 in the 0.3 mg group, and 0 in the 1 mg group. Regarding antibodies that the body might develop against the study drug, 1 participant in the 0.3 mg group and 1 participant in the 1 mg group were reported to have developed these, while none were detected in the other groups. The pharmacokinetic data — measurements of how the drug was processed by the body over time — 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.

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NCT00065806 · results posted 15 August 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 221 participants — 113 in the atorvastatin (a cholesterol-lowering medicine) group and 108 in the placebo (dummy pill) group. The trial was measuring changes in the thickness of the walls of the carotid arteries — the large blood vessels in the neck — using a technique called CIMT (carotid intima-media thickness). Thicker artery walls are considered a marker that researchers monitor in cardiovascular studies. Around 93 people in the atorvastatin group and 89 in the placebo group completed the study. The reported data shows the following changes in artery wall thickness over the course of the trial. For the main (primary) measurement — the average thickness of the common carotid artery — the atorvastatin group showed a reported change of 0.0010 mm, compared with 0.0024 mm in the placebo group. For the secondary measurements, which looked at thickness across a broader range of artery sections and using slightly different averaging methods, the reported changes were also small: for example, the broadest "mean-max" measure showed a change of 0.0037 mm in the atorvastatin group versus 0.0064 mm in the placebo group. When looking specifically at the internal carotid artery (a deeper section of the neck artery), the reported changes were 0.0090 mm (atorvastatin) versus 0.0144 mm (placebo). All measurements were in millimetres and the differences between groups were very small in absolute terms. 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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NCT00430677 · results posted 11 May 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 298 people with lupus nephritis (a form of kidney inflammation linked to the autoimmune condition lupus). Participants were divided into three groups: one received a higher starting dose of abatacept (99 people), one received a lower starting dose of abatacept (99 people), and one received a placebo — a dummy treatment with no active ingredient (100 people). The trial was primarily measuring how long it took each person to achieve a "complete renal response," meaning their kidney function, protein in the urine, and several other markers all returned to near-normal levels at the same time. There was also a shorter, double-blind phase (where neither doctors nor patients knew who received which treatment) lasting about a year, followed by a longer extension period. The reported data shows that for the main outcome — the time taken to first reach a complete renal response — the result was listed as "NA" (not available) for all three groups, meaning this figure was not reported in the submitted data. For the secondary outcomes, the reported data shows that during the short-term period, 22 participants in the higher-dose abatacept group, 27 in the lower-dose abatacept group, and 20 in the placebo group achieved a confirmed complete renal response at any point. By the 12-month mark specifically, those numbers were 9, 11, and 8 participants respectively. When looking at a broader measure — either a complete response or a partial kidney improvement by month 12 — the reported numbers were 38, 37, and 31 participants across the three groups. The reported data also shows that the median time to first reach the kidney improvement milestone was 141 days for the higher-dose group, 136 days for the lower-dose group, and 144 days for the placebo group. The reported data shows that the number of months a complete renal response was maintained was recorded as zero for all three groups, though the way this measure was defined and counted in the trial data is not fully explained in the submission. It is also worth noting that a large number of participants did not complete the longer extension phase — only around 10–11 people per group finished that part of the trial out of the 67–74 who entered 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.

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NCT00377637 · results posted 6 December 2011

According to the results reported on ClinicalTrials.gov, this trial looked at treatments for lupus nephritis (a kidney condition related to the autoimmune disease lupus). It ran in two stages: an induction phase (initial treatment) and a maintenance phase (longer-term treatment). In the induction phase, 185 people were assigned to receive either cyclophosphamide (an older medicine given by drip) or mycophenolate mofetil (a tablet-based medicine), with around 156–150 completing that stage. Those who responded in the induction phase could then enter the maintenance phase, where 116 people continued on mycophenolate mofetil and 111 switched to azathioprine (another tablet-based medicine), with 73 and 54 respectively completing that stage. The reported data shows that in the induction phase, 104 out of 185 people in the mycophenolate mofetil group showed a treatment response (as measured by improvements in protein in the urine and kidney function markers) compared with 98 out of 185 in the cyclophosphamide group. For complete remission — a stricter standard involving return to normal kidney function and very low protein levels — 16 people in the mycophenolate mofetil group and 15 in the cyclophosphamide group met that definition. Both groups also showed reductions in urine protein levels and changes in kidney-related blood measurements over the 24 weeks, with the specific average figures reported but no clear difference between groups noted in the data provided. In the maintenance phase, the reported data shows the percentage of participants who had not experienced "treatment failure" (defined as death, kidney failure, a significant worsening of kidney function, a flare-up, or needing rescue treatment) at various time points. By the end of the follow-up period, an estimated 84.9% of those on mycophenolate mofetil and 74.1% of those on azathioprine were reported as treatment-failure free, based on a statistical estimation method that accounts for people leaving the study at different times. 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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NCT00119678 · results posted 9 May 2011

According to the results reported on ClinicalTrials.gov, this trial (NCT00119678) looked at abatacept, a medicine given by infusion, compared to a placebo (an inactive dummy treatment) in people with systemic lupus erythematosus (SLE, commonly known as lupus) who were experiencing a flare-up of their condition. Around 122 people were assigned to the abatacept group and 61 to the placebo group during the main double-blind phase (where neither the participants nor the doctors knew who was receiving which treatment). The trial's main goal was to measure how many participants experienced a new lupus flare after their initial flare had settled down. The reported data shows that, during the double-blind period, 94 out of 121 treated participants in the abatacept group and 47 out of 59 in the placebo group experienced a new lupus flare — meaning the large majority in both groups had a flare during the study period. Looking at just the first six months, the reported numbers were 75 in the abatacept group and 36 in the placebo group. The reported median time (the midpoint figure — half of participants reached this point sooner, half later) before a first new flare was 107 days for the abatacept group and 92 days for the placebo group. Regarding adverse events (unwanted medical occurrences during the trial), the reported data shows 110 of 121 abatacept participants and 54 of 59 placebo participants experienced at least one adverse event; serious adverse events were reported in 24 abatacept and 4 placebo participants; and 10 abatacept versus 3 placebo participants stopped the study due to an adverse event. No deaths were reported in either group during this 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.

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NCT00424476 · results posted 5 May 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 865 people with lupus (systemic lupus erythematosus) across three groups: 287 received a placebo (a dummy treatment with no active ingredient), 288 received a lower dose of belimumab (1 mg/kg), and 290 received a higher dose of belimumab (10 mg/kg). The trial ran for 52 weeks and was primarily measuring how many participants met a combined set of criteria — known as the SLE Responder Index — that looked at changes in disease activity scores, the doctor's overall assessment of disease severity, and whether any new organ systems were affected. The reported data shows that at week 52, 43.6% of people in the placebo group met the main response criteria, compared with 51.4% in the lower-dose belimumab group and 57.6% in the higher-dose belimumab group. For a related secondary measure — looking only at whether the disease activity score improved by at least 4 points — the reported figures were 46.0% (placebo), 53.1% (lower dose), and 58.3% (higher dose). Doctors' ratings of overall disease severity (on a scale of 0–3) showed small reductions from the starting point in all three groups at week 24: −0.39 for placebo, −0.44 for the lower dose, and −0.54 for the higher dose. Among participants who were taking the steroid prednisone at the start, the proportion who managed to reduce their average dose by at least 25% down to 7.5 mg or less per day (between weeks 40 and 52) was reported as 12.0% for placebo, 20.6% for the lower dose, and 18.6% for the higher dose. Scores measuring physical quality of life (from a 36-question health survey) improved by a similar amount across all three groups, and those figures were not notably different between the placebo and belimumab 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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NCT00381810 · results posted 18 December 2009

According to the results reported on ClinicalTrials.gov, this trial enrolled 31 people, all of whom received a 1,000 mg dose of a medicine called rituximab. The trial was tracking what happened to participants over two phases: a treatment and safety follow-up period, and then a separate period monitoring a specific type of blood cell (B cells). Of the 31 people who started the treatment phase, 16 completed it and 15 did not. Of the 7 people who entered the B cell follow-up phase, none completed it — though the data does not explain the reasons for non-completion in either phase. The reported data shows that the trial had one primary outcome measure: tracking how many participants experienced at least one "serious adverse event." A serious adverse event, as defined in this trial, is an unwanted health event that results in death, is life-threatening, requires a hospital stay, leads to significant disability, causes a birth defect, or is considered a significant medical event by the treating doctor. According to the results reported on ClinicalTrials.gov, 35.5% of participants — roughly just over one in three — were reported to have experienced at least one such event. No secondary outcome measures were included in the submitted results data. It is worth noting that this trial only had one reported outcome measure, focused on serious adverse events, and no other findings (such as whether the treatment changed any disease symptoms) were included in the data submitted. 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.