Reported trial results for Vasculitis

42 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

• NCT01917721 · results posted 3 June 2026

  According to the results reported on ClinicalTrials.gov, this trial looked at a treatment called doxycycline (an antibiotic) compared to a placebo (a dummy treatment with no active ingredient) in children with Kawasaki disease, a condition that can cause inflammation of the blood vessels including the arteries around the heart. A total of 26 children took part — 15 in the doxycycline group and 11 in the placebo group. The trial's main focus was on measuring changes in the size of the coronary arteries (the arteries that supply blood to the heart) over roughly four weeks, using a standardised scoring system called a "Z-score," where a higher number means a larger-than-average artery size. The reported data shows that, for the primary measure — the change in coronary artery Z-scores — the doxycycline group had reported values of 1.56 and 1.45, while the placebo group had reported values of 1.25 and 1.98. (Note: the data as submitted includes two separate measurements per group, but further detail about what each measurement represents was not provided in the structured results.) For the secondary measures, blood levels of a protein called MMP-9 (which is involved in inflammation) were reported as 90 micrograms per millilitre in the doxycycline group and 80 in the placebo group. Levels of another protein called TIMP (which interacts with MMP-9) were reported as 105 micrograms per millilitre in the doxycycline group and 115 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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• NCT03557060 · results posted 18 February 2026

  According to the results reported on ClinicalTrials.gov, this trial followed people in Japan who had been diagnosed with a condition called EGPA (eosinophilic granulomatosis with polyangiitis — a rare disease affecting blood vessels). A total of 4,115 people were enrolled, of whom 836 were included in the main safety analysis. The trial was an observational study tracking real-world use of a medicine called mepolizumab (NUCALA), and it measured three things: how many participants experienced side effects thought to be linked to the medicine, how many participants' doctors rated the treatment as effective based on their symptoms, and how long it took before participants experienced a relapse (a return or worsening) of their EGPA. The reported data shows that out of the 836 participants in the safety analysis group, 57 experienced what are called adverse drug reactions — that is, unwanted effects where a link to the medicine could not be ruled out. The reported data also shows that 95.1% of participants were rated by their doctors as having responded to treatment, based on an overall assessment of their symptoms. Regarding relapses, the reported average time to a first EGPA relapse was 133.7 days; however, it is important to note that not all details about how this figure was calculated across the full group were provided in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03906227 · results posted 26 November 2025

  According to the results reported on ClinicalTrials.gov, this trial enrolled a very small number of participants — just seven people in total across three groups. The groups were defined by levels of a particular immune cell marker called CD5+ and whether participants were receiving maintenance treatment. One person was in the "Low CD5+, on Maintenance" group, four were in the "High CD5, on Maintenance" group, and two were in the "High CD5, No Maintenance" group. The trial was measuring how long it took for a condition called vasculitis (inflammation of blood vessels) to return after a period of no symptoms, and tracking how often and how severely that return of symptoms (called a relapse) occurred. The reported data shows that for the primary outcome — time to first relapse — only the "Low CD5+, on Maintenance" group had a recorded result, which was 7.1 months. No data was reported for the other two groups for this measure. For the secondary outcomes, the reported data shows that one relapse was recorded in the "Low CD5+, on Maintenance" group, while zero relapses were recorded in the other two groups. No major relapses (those involving a major organ) were reported in any group. Regarding infections, one infection was reported in the "High CD5, No Maintenance" group, and none in the other two groups. The measure tracking time to a positive ANCA blood test result was not reported for any group. It is important to note that with only seven participants, this was an extremely small study, and two participants in the "High CD5, on Maintenance" group did not complete the trial. The reported data shows limited information, and several outcome measures were not able to be fully reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03725202 · results posted 7 March 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT03725202) enrolled 429 adults with giant cell arteritis (GCA) — an inflammatory condition affecting blood vessels, particularly in the head. Participants were randomly divided into three groups: 112 received a placebo (dummy pill) alongside a 52-week course of corticosteroids (a type of steroid medicine used to reduce inflammation); 107 received a lower dose (7.5 mg) of a drug called upadacitinib alongside a shorter 26-week corticosteroid course; and 210 received a higher dose (15 mg) of upadacitinib alongside the same shorter corticosteroid course. The trial's main goal was to measure how many participants reached "sustained remission" — meaning no signs or symptoms of GCA from Week 12 through to Week 52, while sticking to their steroid-tapering schedule. The reported data shows that for the primary goal of sustained remission at Week 52, 29.0% of the placebo group reached this point, compared with 41.1% in the 7.5 mg upadacitinib group and 46.4% in the 15 mg upadacitinib group. For a stricter measure called "sustained complete remission" (which also required blood inflammation markers to return to normal), the reported figures were 16.1%, 26.2%, and 37.1% respectively. When looking at who was in complete remission specifically at Week 52, the reported percentages were 19.6% (placebo), 43.0% (7.5 mg), and 50.2% (15 mg). The reported data also shows that 55.6% of participants in the placebo group experienced at least one disease flare (a return of symptoms serious enough to need more steroids) during the 52 weeks, compared with 41.3% in the 7.5 mg group and 34.3% in the 15 mg group. The median time to a first flare in the placebo group was reported as 323 days; this figure was not reported for either upadacitinib group. The total amount of corticosteroids taken over 52 weeks was reported as approximately 2,882 mg in the placebo group, 1,905 mg in the 7.5 mg group, and 1,615 mg in the 15 mg group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04671446 · results posted 30 January 2025

  According to the results reported on ClinicalTrials.gov, this study enrolled 120 people across four groups: 63 people with severe eosinophilic asthma (a type of asthma involving high levels of certain white blood cells), 30 healthy volunteers, 17 people with a condition called EGPA (a rare inflammatory disease also involving those same white blood cells), and 10 people with other respiratory conditions. All 120 participants completed the study. The trial was investigating whether people in these groups carry certain "autoantibodies" — proteins the immune system produces that can mistakenly target the body's own tissues — and looking at features of immune cells in the blood. The reported data shows that, for the main measurement (a laboratory test called an ELISA looking for autoantibodies against a panel of four targets), 19 out of 63 people with severe eosinophilic asthma tested positive, compared with 4 out of 30 healthy volunteers, 3 out of 17 people with EGPA, and 4 out of 10 people with other respiratory conditions. A second test, which used a different laboratory technique (immunofluorescence — essentially using a fluorescent marker to look for immune reactions on white blood cells), found positive results in 9 out of 63 people with severe eosinophilic asthma, 1 out of 30 healthy volunteers, and 3 out of 17 people with EGPA; a figure for the "other respiratory conditions" group was not reported for this measure. The study also looked at the make-up of immune cells in the blood in more detail; the reported data shows small percentage differences between groups in several immune cell subtypes, though the meaning of those differences is not described 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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• NCT02703922 · results posted 13 December 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 165 people who were suspected of having a condition called giant cell arteritis (GCA) — an inflammation of the arteries, particularly around the temples. Participants were divided into two groups based on the result of a colour Doppler ultrasound (CDU) scan, a type of imaging that looks at blood flow in arteries: 73 people whose scan result was "positive" (suggesting GCA) and 92 whose result was "negative." The trial was measuring how accurately the CDU scan identified people who truly had the condition, and also looked at a surgical biopsy of the temporal artery (a small tissue sample taken from near the temple) as a comparison test. Overall, 58 people in the positive group and 74 in the negative group completed the study. The reported data shows that the main thing being measured was how many people in the CDU-positive group turned out to have a different diagnosis within two years — in other words, how often the scan may have pointed in the wrong direction. According to the results, none of the 73 CDU-positive participants received an alternative diagnosis, while 29 of the 63 participants assessed in the CDU-negative group did receive an alternative diagnosis over follow-up. For the secondary outcomes, the reported data shows that among the CDU-negative group, 7 out of 28 people who went on to have a temporal artery biopsy returned a positive biopsy result. Regarding a follow-up ultrasound in the CDU-positive group, 25 out of 30 participants assessed showed a persistent "halo" (a specific pattern seen on the scan) at their second examination. The reported data also includes figures relating to how consistently the scans and biopsies were interpreted by different reviewers, though the breakdown of those numbers is complex and not fully detailed 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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• NCT04882072 · results posted 2 December 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT04882072) studied ustekinumab as a treatment for Takayasu arteritis — a rare condition where the immune system attacks the body's large blood vessels. The trial enrolled 14 participants in total: 8 were assigned to receive a placebo first, then ustekinumab, and 6 received ustekinumab throughout. The trial ran in two stages — a blinded phase (where participants didn't know which treatment they were receiving) lasting roughly 71 weeks, followed by an open-label extension (where everyone received ustekinumab) of a further 63 weeks. The main thing the trial was measuring was how long it took for participants' disease to flare up again (called "time to relapse"), with a relapse defined by signs across several categories including fever, joint pain, inflammation markers in the blood, and vascular (blood vessel) symptoms. The reported data shows that, during the blinded phase, the median time to relapse — that is, the point at which half of the participants in each group had experienced a flare — was approximately 12.6 weeks in the placebo group and approximately 11.1 weeks in the ustekinumab group. These figures were the same whether relapse was defined by the trial's own criteria or by a separate standard set of criteria (known as Kerr's criteria). When relapse was measured based on clinical symptoms alone, the reported median time was around 12.1 weeks for the placebo group and approximately 4.1 weeks for the ustekinumab group. Regarding unwanted medical events, the reported data shows that during the blinded phase, 6 out of 8 placebo participants and 5 out of 6 ustekinumab participants experienced treatment-emergent adverse events (meaning any medical event that occurred after starting the study drug). Serious adverse events — those considered more severe, such as requiring hospitalisation — were reported in 1 participant in each of the blinded groups. The trial was very small, and the data as submitted does not include fuller statistical analyses for several of the 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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• NCT04551989 · results posted 19 September 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 118 people diagnosed with a rare inflammatory condition called eosinophilic granulomatosis with polyangiitis (EGPA), sometimes known as a type of blood vessel inflammation linked to high levels of a particular white blood cell. All participants received a medicine called mepolizumab at a dose of 300 mg. The trial was primarily tracking any unwanted medical events (called adverse events) that participants experienced during the study, as well as looking at things like disease flare-ups, hospital visits, and changes in symptoms across nine body systems. Of the 118 who started, 107 completed the study and 11 did not. The reported data shows that, out of 118 participants, 69 experienced at least one adverse event (an unwanted medical occurrence during the study), 26 experienced a serious adverse event (one considered more severe, such as requiring hospitalisation), and 42 experienced an adverse event of special interest — a category that included allergic reactions, infections, and tumours. The reported data also shows that zero participants were recorded as having an adverse drug reaction directly linked to the study medicine. For the secondary measures, at the final observation point, 100% of participants were recorded as having no active or worsening clinical symptoms across the nine body systems assessed. Around 10% of participants experienced a disease relapse (a return or worsening of their EGPA requiring a change in treatment). The estimated rate of hospital admissions related to EGPA was reported as 0.02 events per person per year, and unplanned emergency or unscheduled visits related to EGPA were estimated at 0.07 events per person per year. 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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• NCT04413149 · results posted 17 May 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled two groups of participants: 31 people in the MPA-ILD group (a condition involving lung disease linked to a type of blood vessel inflammation) and 49 people in the ANCA-IIP group (a related lung condition). The trial was tracking two main outcomes over the study period — how many participants died from any cause, and how many received a lung transplant. The reported data shows that in the MPA-ILD group, 10 out of 31 participants died from any cause during the study, and 1 participant received a lung transplant. In the ANCA-IIP group, 5 out of 49 participants died from any cause, and no participants received a lung transplant. It is also worth noting that 11 participants in the MPA-ILD group and 5 in the ANCA-IIP group did not complete the study, though the reasons for this were not reported in the data provided. No secondary outcome measures 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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• NCT02179853 · results posted 4 March 2024

  According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called anakinra, given at three different daily dose levels. A total of 22 people took part — 4 in the lowest dose group (2–4 mg/kg/day), 3 in the middle dose group (5–7 mg/kg/day), and 15 in the highest dose group (8–11 mg/kg/day). All 22 participants who started the trial completed it. The reported data shows that the trial's primary (main) focus was on recording how many participants experienced adverse events — meaning any unwanted or unexpected health changes noted during the study. The numbers reported were: 2 out of 4 participants in the lowest dose group, 3 out of 3 in the middle dose group, and 13 out of 15 in the highest dose group experienced at least one adverse event. The trial did not report any secondary outcome measures in the data submitted to ClinicalTrials.gov. No further detail about the nature or severity of those adverse events was included in the structured results 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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• NCT03827018 · results posted 17 October 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT03827018) looked at a medicine called mavrilimumab for people with a condition called giant cell arteritis (GCA), which is an inflammation of blood vessels. A total of 70 people took part — 42 received mavrilimumab and 28 received a placebo (a dummy treatment with no active ingredient). The main thing the trial was measuring was how long it took for participants' symptoms to flare up again over a 26-week period. Participants also followed a steroid-tapering schedule during the study. The reported data shows that for the primary measure — time to flare — the mavrilimumab group did not reach a median time to flare during the 26 weeks (meaning fewer than half of that group had a flare by the end of the study period), while the placebo group reached a median of about 25 weeks before a flare occurred. For one of the secondary measures, the reported data shows that approximately 83% of people in the mavrilimumab group completed the 26 weeks without a flare, compared with approximately 50% in the placebo group. For two blood markers linked to inflammation — ESR and CRP — the mavrilimumab group took longer to show elevated readings than the placebo group, though the exact median times for CRP and for signs/symptoms in the mavrilimumab group were not reached within the study period and so were not reported as a specific number. The reported data also shows that the total cumulative dose of corticosteroids (a type of steroid medicine) taken over 26 weeks was approximately 2,074 mg in the mavrilimumab group and approximately 2,403 mg in the placebo group, though the reasons for this difference are not explained 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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• NCT02222155 · results posted 16 August 2023

  According to the results reported on ClinicalTrials.gov, this trial involved 42 people in total across three groups: 13 received a placebo (a dummy treatment) twice daily alongside standard care, 13 received a low dose (10 mg) of an investigational drug called CCX168 twice daily alongside standard care, and 16 received a higher dose (30 mg) of CCX168 twice daily alongside standard care. The trial was studying people with a condition called ANCA-associated vasculitis — an illness where the body's immune system attacks blood vessels. The trial was measuring how often unwanted health events occurred, and how many participants showed signs of improvement in their disease activity over approximately 85 days (about 12 weeks). The reported data shows that when it came to the main disease activity measure — a scoring tool called the Birmingham Vasculitis Activity Score (BVAS), where a lower score means less active disease — a large proportion of participants across all three groups showed at least a 50% reduction in their score by Day 85: roughly 85% in the placebo group, 92% in the low-dose CCX168 group, and 80% in the high-dose CCX168 group. For the proportion of participants whose disease activity score reached zero (considered full remission) by Day 85, the reported figures were approximately 54% for placebo, 67% for the low-dose group, and 47% for the high-dose group. The reported data also shows that the average percentage change in the disease score from the start of the trial to Day 85 was around −82% for the placebo group, −96% for the low-dose group, and −82% for the high-dose group — where a negative number means the score went down (i.e., disease activity appeared lower). Regarding unwanted health events, 13 out of 13 participants in the placebo group, 11 out of 13 in the low-dose group, and 15 out of 16 in the high-dose group were reported to have experienced at least one such event during the study. The reported data also shows results for kidney-related signs in participants who had certain kidney abnormalities at the start of the trial. Among those participants, the proportion showing improvement in kidney measures by Day 85 was reported as approximately 17% in the placebo group, 40% in the low-dose CCX168 group, and 63% in the high-dose CCX168 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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• NCT03765788 · results posted 26 April 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT03765788) looked at a condition called Giant Cell Arteritis (GCA) — an inflammatory condition affecting blood vessels, particularly in the head. The trial enrolled 52 people in total: 27 received the study drug secukinumab and 25 received a placebo (a dummy treatment with no active ingredient). Both groups also took a steroid called prednisolone, which was gradually reduced over the course of the study. The trial's main goal was to measure how many participants stayed in "remission" — meaning they had no return of GCA symptoms — all the way through to week 28. The reported data shows that, for the primary goal (staying in remission through to week 28), 19 out of 27 participants in the secukinumab group and 6 out of 25 in the placebo group met this measure. For the secondary measures: at week 12, remission was reported in 22 of 27 secukinumab participants and 12 of 25 placebo participants. When looking further out to week 52, 16 of 27 in the secukinumab group and 2 of 25 in the placebo group were reported to still be in remission. For the time it took until a first return of symptoms after remission, a specific figure was not reported for the secukinumab group, while the placebo group's reported figure was 197 days. The total amount of prednisolone taken over 28 weeks was reported as approximately 2,690 mg in the secukinumab group and 2,694 mg in the placebo group; over 52 weeks, those figures were approximately 2,841 mg and 3,376 mg respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02994927 · results posted 9 September 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT02994927) enrolled 331 people in total — 165 in the prednisone group and 166 in the avacopan group — all of whom had a condition called ANCA-associated vasculitis, a disease where the immune system attacks small blood vessels. The trial was measuring whether participants reached "remission" (meaning no signs of active disease, based on a standard scoring tool called BVAS, and no need for steroid treatment) at two points in time: 26 weeks and 52 weeks. Around 150–151 people in each group completed the study. The reported data shows that at 26 weeks, 70.1% of participants in the prednisone group and 72.3% in the avacopan group had reached remission as defined by the trial. At 52 weeks — where remission also had to be maintained without relapse since the 26-week mark — 54.9% of the prednisone group and 65.7% of the avacopan group met that sustained remission definition. For secondary measures, the trial also tracked a "Glucocorticoid Toxicity Index" (a scoring tool for side effects associated with steroid use, where higher scores indicate more toxicity), and the reported scores were higher in the prednisone group than the avacopan group across multiple measurements over 26 weeks. Health-related quality-of-life scores (measured using standard questionnaires called SF-36v2 and EQ-5D-5L, where higher numbers mean better quality of life) showed changes from starting scores in both groups over 52 weeks, with the avacopan group generally reporting larger improvements in the numbers recorded. The reported data also shows counts of adverse events (unwanted health occurrences during the trial): the total number of such events recorded was 2,139 in the prednisone group and 1,779 in the avacopan group, with 74 and 70 participants respectively experiencing serious adverse events, and 28 and 27 withdrawing from the trial due to adverse events. These numbers describe what was recorded and counted in the trial; they do not on their own tell us why differences occurred. 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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• NCT03895801 · results posted 25 August 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03895801) enrolled 57 people across three groups who had a form of inflammatory blood vessel disease called vasculitis. The three groups were: 18 people who received a drug called IFX-1 alongside a placebo (inactive substitute) for steroid tablets; 24 people who received a placebo for IFX-1 alongside a standard dose of steroid tablets (called glucocorticoids, or GC); and 15 people who received IFX-1 alongside a reduced dose of steroid tablets. The trial's main goal was to measure how many people in each group achieved a meaningful reduction in their disease activity score (called BVASv3, a scale from 0 to 63 where higher numbers mean more active disease). The reported data shows that, for the primary goal of achieving at least a 50% reduction in disease activity score, 16 out of 18 participants in the IFX-1 plus placebo-GC group, 22 out of 24 in the standard-dose steroid group, and 10 out of 15 in the IFX-1 plus reduced-dose steroid group met this measure. For the secondary goal of full remission (a disease activity score of zero), the reported numbers were 14 out of 18, 20 out of 24, and 10 out of 15 respectively. The reported data also shows that average disease activity scores dropped across all three groups during the trial — by roughly 13.8, 14.7, and 16.6 points from their starting levels in each group. The reported data also includes scores from doctors' overall assessments of disease activity (on a scale of 0 to 10), which were 0.4, 0.1, and 0.7 for the three groups, and a measure of organ damage (on a scale of 0 to 64), recorded at 1.0, 1.5, and 1.9 respectively. A measure of kidney function was also reported, with average values of 50.2, 57.0, and 51.2 (in standard units) across 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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• NCT03712345 · results posted 26 May 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03712345) enrolled 20 people in total, split across three groups: 6 received a high dose of IFX-1, 7 received a low dose of IFX-1, and 7 received a placebo (an inactive treatment given for comparison). Nearly all participants finished the study — one person in the placebo group did not complete it. The trial was primarily measuring how many participants experienced a treatment-emergent adverse event (TEAE), meaning any unwanted medical event that occurred after the treatment began. It also looked at a number of secondary measures, including how many participants showed a clinical response or full remission based on a disease scoring tool called BVAS (a standardised checklist doctors use to rate disease activity), as well as how much of the study drug was present in participants' blood. The reported data shows that, for the primary measure, all 6 participants in the high-dose IFX-1 group, all 7 in the low-dose group, and 5 out of 6 completing participants in the placebo group experienced at least one such event. For the secondary measures related to disease activity, 5 out of 6 high-dose, 6 out of 7 low-dose, and 6 out of 6 placebo participants showed a clinical response (a reduction of at least 50% in their BVAS score). Regarding full remission (a BVAS score of zero), the reported numbers were 3 out of 6 in the high-dose group, 6 out of 7 in the low-dose group, and 4 out of 6 in the placebo group. Blood concentration measurements of IFX-1 were also reported, and data for the detailed pharmacokinetic (drug-tracking) substudy was not reported in the submitted results. It is worth noting that this was a very small trial, and the numbers in each group are too small to draw broad conclusions. The reported data shows only what was observed in these specific participants during this 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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• NCT03026504 · results posted 8 April 2022

  According to the results reported on ClinicalTrials.gov, this trial enrolled 15 people, all in a single group, who received a medicine called baricitinib. Fourteen of the 15 participants completed the study, while one did not finish. The trial was looking at a condition called Giant Cell Arteritis (GCA) — a type of blood vessel inflammation — and was measuring things like unwanted side effects, whether the condition came back (called a "relapse"), and blood markers that can indicate inflammation in the body. The reported data shows that 93% of participants (roughly 13 or 14 out of 15) experienced at least one adverse event, meaning an unwanted or unexpected health occurrence during the study. Regarding relapses of GCA, the data shows that 1 participant experienced a relapse at 24 weeks into the study, and 1 participant experienced a relapse at 52 weeks. For the blood inflammation markers, the reported data shows an average ESR (a measure of inflammation in the blood — lower numbers generally mean less inflammation) of 7 mm/hr at one point in time, 13 mm/hr at another, and 10 mm/hr at a third. For CRP (another blood marker of inflammation, where lower levels generally suggest less inflammation), an average of 3.4 mg/L was reported at one time point; the data for the remaining two time points was not reported. It is worth noting that because this trial involved only 15 people and had no comparison group, the reported numbers on their own are limited in what they can tell us about the medicine more broadly. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01697267 · results posted 18 March 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT01697267) enrolled 170 people in total — 85 in a group receiving rituximab as a maintenance treatment and 85 in a group receiving azathioprine as a maintenance treatment. The trial was measuring how well each treatment kept a disease called ANCA-associated vasculitis (an inflammatory condition affecting blood vessels) in remission over time, and tracked things like disease flare-ups (relapses), ongoing remission, cumulative disease damage, steroid doses used, serious unwanted events, and infection rates. The reported data shows that for the main outcome — staying free of a relapse — 38 participants in the rituximab group and 60 participants in the azathioprine group experienced a relapse of some kind during the study. Breaking that down, the reported data shows 13 people in the rituximab group and 32 in the azathioprine group had a major relapse, while 25 and 28 respectively had a minor relapse. For remission at 24 months, 73 participants in the rituximab group and 70 in the azathioprine group were reported to be in remission; at 48 months those numbers were 54 and 44 respectively. The reported data also shows that cumulative disease damage scores (on a scale where a higher number means more accumulated damage, out of a maximum of 64) were broadly similar and low in both groups across the study period. Steroid (glucocorticoid) exposure during the treatment period was reported as an average of 3,717 mg in the rituximab group and 4,780 mg in the azathioprine group, with whole-trial figures of 2,184 mg and 2,426 mg respectively (noting that follow-up duration varied between participants). The reported data shows 37 participants in the rituximab group and 48 in the azathioprine group experienced a serious adverse event, and 54 versus 62 participants respectively experienced an infection requiring antibiotics. 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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• NCT03600805 · results posted 14 January 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03600805) enrolled 83 people with giant cell arteritis — a condition involving inflammation of blood vessels, particularly in the head. Participants were divided into four groups: two groups received a placebo (inactive) injection alongside a steroid (prednisone) that was gradually reduced over either 52 weeks or 26 weeks, and two groups received the medicine sarilumab (at different doses — 150 mg or 200 mg, given every two weeks) alongside the 26-week steroid taper. The trial was primarily measuring how many people in each group achieved "sustained remission" — meaning their symptoms had settled, a blood marker of inflammation (C-reactive protein, or CRP) had returned to a normal level, and they had stayed that way without a flare-up or needing extra steroids — by Week 24 and Week 52. The reported data shows that, for the primary goal of sustained remission by Week 52, 30% of participants in the placebo with 52-week taper group, 0% in the placebo with 26-week taper group, 42.9% in the sarilumab 150 mg group, and 46.2% in the sarilumab 200 mg group met that measure. For sustained remission by Week 24, the reported figures were 39.3%, 7.1%, 42.9%, and 48.1% respectively. For the secondary measures, the reported data shows that by Week 12, the number of participants recorded as having achieved remission (in the full study population) was 16 out of 28 in the placebo/52-week taper group, 6 out of 14 in the placebo/26-week taper group, 9 out of 14 in the sarilumab 150 mg group, and 15 out of 27 in the sarilumab 200 mg group. The numbers of participants who did not experience a disease flare between Week 12 and Week 24 were also reported as 21, 7, 10, and 15 across the four groups respectively. It is worth noting that the groups were quite small, which limits how much can be read into these numbers. The reported data also shows that a notable proportion of participants in each group did not complete the full 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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• NCT01363388 · results posted 27 July 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 67 people in total across three groups. One group (23 people) received a placebo tablet twice daily alongside a higher dose of the steroid prednisone (60 mg). A second group (22 people) received the investigational drug CCX168 (30 mg twice daily) alongside a lower dose of prednisone (20 mg). A third group (22 people) received CCX168 (30 mg twice daily) with no prednisone at all. The trial was primarily measuring how many participants achieved a meaningful reduction in disease activity by Day 85 (roughly 12 weeks), using a scoring tool called the Birmingham Vasculitis Activity Score (BVAS) — a numbered scale where a higher score means more active disease. The reported data shows that for the main outcome — at least a 50% reduction in the BVAS disease activity score by Day 85 — the proportions were: 0.70 (70%) in the placebo-plus-high-dose-prednisone group, 0.86 (86%) in the CCX168-plus-low-dose-prednisone group, and 0.81 (81%) in the CCX168-without-prednisone group. For the secondary outcomes, the proportion of participants showing improvement in kidney-related measurements was reported as 0.40 (40%), 0.56 (56%), and 0.33 (33%) across the three groups respectively. The proportion reaching full disease remission (a BVAS score of nearly zero) was 0.35 (35%), 0.27 (27%), and 0.19 (19%). The reported average percentage change in the BVAS score from the start of the trial was a reduction of about 56% in the placebo group, 79% in the CCX168-plus-low-dose-prednisone group, and 73% in the CCX168-without-prednisone group — where a negative (downward) change indicates lower disease activity. Changes in kidney filtration rates and other secondary measures were also reported, with the data varying 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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• NCT03658889 · results posted 28 May 2020

  According to the results reported on ClinicalTrials.gov, this study (NCT03658889) enrolled 308 patients who had been diagnosed with giant cell arteritis (GCA) — a condition affecting blood vessels — along with 69 doctors who treated them. The study was observational, meaning it was designed to map out the patient's journey from first symptoms through to diagnosis and treatment, rather than testing a new medicine. Of the 308 patients, 306 completed the study. The reported data shows that the median time between a patient first noticing signs or symptoms and receiving a GCA diagnosis was 1 month. When it came to which doctors referred patients, the largest number — 171 out of 308 — were referred by one particular specialty (the specific specialty labels were not included in the submitted data). Across the whole journey since their first GCA-related events, 260 patients had seen at least one type of specialist, with smaller numbers seeing a range of other doctor types. Regarding how the condition was diagnosed, several different methods were recorded across the group, with counts ranging from 20 to 266 participants for each method, though the specific method names were not included in the submitted data fields provided here. For treatment, 273 patients were recorded as being on a corticosteroid (a type of anti-inflammatory medication) at the time they entered the study. The reported median current corticosteroid dose at that point was 9 mg, and the reported median total cumulative dose since diagnosis was 4,305 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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• NCT00987389 · results posted 26 May 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 704 people in total, split across four groups depending on whether they received plasma exchange (a procedure that filters the blood) and whether they received a standard or reduced dose of steroid-type medicines called glucocorticoids. The trial was measuring whether plasma exchange made a difference to serious outcomes — specifically, how many participants either died from any cause or developed end-stage kidney disease (meaning their kidneys had failed badly enough to need at least 12 weeks of ongoing kidney replacement treatment such as dialysis). The reported data shows that, for the main outcome, 100 out of the participants in the plasma exchange groups reached the combined endpoint of death or end-stage kidney disease, compared with 109 out of the participants in the no plasma exchange groups. For the secondary outcomes, the number of participants who achieved sustained remission (disease under control from before six months and remaining stable to at least 12 months) was reported as 200 in the plasma exchange groups and 197 in the no plasma exchange groups. Serious infection events — infections serious enough to need intravenous antibiotics or a hospital stay — were recorded as 145 events in the plasma exchange groups and 132 in the no plasma exchange groups. Quality-of-life scores were also measured using standard questionnaires; on the physical health scale (scored 0–100, where higher means better), the plasma exchange groups averaged 39.04 and the no plasma exchange groups averaged 37.96. Mental health scores were 51.94 versus 51.40, and a separate overall health score (where 1 represents perfect health) was 0.79 versus 0.77, respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02084147 · results posted 29 October 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 72 participants, and all 72 completed the study with no drop-outs. The trial was comparing two types of body scanning technology — PET-CT (a combination of two well-known scan types) and PET-MRI (a newer combination) — to see how they measured up against each other. The study looked at things like image quality, how well each scan detected abnormalities, how long each approach took, and how much radiation exposure was involved. The reported data shows that five primary outcomes were planned to be measured: overall image quality, the level of radioactive tracer picked up in specific areas of the body (called SUV, or "standardised uptake value" — a way of measuring scanner readings in tissue), the accuracy of each scan at detecting findings, the time it took to complete each type of scan, and the amount of radiation each participant received. However, the numerical results for all five of these outcome measures were not reported in the data submitted to ClinicalTrials.gov. This means it is not possible to describe what the actual figures showed for any of these measurements. Because no outcome numbers were included in the submitted results, it is unclear what the trial found across any of its planned comparisons. The data was simply not reported for these measures on the registry. 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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• NCT01431105 · results posted 4 June 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 34 participants, all of whom were in a single group receiving atorvastatin. All 34 participants completed the study, and none dropped out. The trial ran for six weeks and was measuring how many participants experienced a Serious Adverse Event (SAE) — meaning a significant, unexpected medical problem — during that time. The reported data shows that the only outcome measure recorded was the number of participants who experienced a Serious Adverse Event during the six-week study period. Out of 34 participants, 4 were reported as having experienced a Serious Adverse Event. No other outcome measures — such as measures of how well the treatment may have worked — appear to have been reported in the submitted results data 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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• NCT02531633 · results posted 31 May 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 161 people across five treatment groups in its first phase (Part A, lasting 52 weeks). Participants were testing a medicine called sirukumab (SIR) — given by injection under the skin at different doses and schedules — compared to a placebo (dummy injection), with all groups also taking a steroid called prednisone for varying lengths of time. The trial was studying giant cell arteritis (GCA), an inflammatory condition affecting blood vessels. The main thing being measured was how many people reached and stayed in "sustained remission" — meaning their symptoms had cleared, their blood markers of inflammation had returned to normal, they had completed their prednisone course, and had not needed any extra treatment — all the way to week 52. Participants who achieved that sustained remission could then continue into a second phase (Part B, lasting a further 104 weeks). The reported data shows that very small numbers of participants reached the primary goal of sustained remission at week 52. In the group receiving sirukumab 100 mg every two weeks combined with six months of prednisone, 3 out of 42 participants met this definition. In the sirukumab 100 mg every two weeks with three months of prednisone group, 2 out of 39 did so. In the sirukumab 50 mg every four weeks with six months of prednisone group, 1 out of 26 did. In both placebo groups — one with six months of prednisone (27 participants) and one with 12 months of prednisone (27 participants) — zero participants met the sustained remission definition. For the secondary outcomes, the reported data for time to first disease flare was listed as "not available" across all groups in both parts of the trial, and Part B results were largely not reported due to the very small numbers who progressed to that phase. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01450137 · results posted 12 February 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 30 participants in total — 20 received a medicine called tocilizumab and 10 received a placebo (a dummy treatment with no active ingredient). The trial was studying a condition where the body's immune system attacks blood vessels, and it was measuring things like whether the disease went into complete remission (meaning no active signs of disease), whether it stayed away without a relapse (a return of symptoms), how much steroid medication (prednisolone) participants needed over the course of the trial, and how long participants went without a relapse after their disease initially settled. The reported data shows that, for the main goal of the trial — the number of participants who reached complete remission — 17 out of 20 people in the tocilizumab group and 4 out of 10 people in the placebo group met that mark. For the secondary measurements, the reported data shows that 17 out of 20 tocilizumab participants and 2 out of 10 placebo participants remained relapse-free. The cumulative (total added-up) steroid dose was reported as 43 mg/kg in the tocilizumab group compared with 110 mg/kg in the placebo group. The average time participants went without a relapse after remission was reported as 50 weeks in the tocilizumab group and 25 weeks in the placebo group. It is worth noting that this was a small trial with only 30 participants across both groups, so the numbers represent a limited snapshot. 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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• NCT01596335 · results posted 26 September 2018

  According to the results reported on ClinicalTrials.gov, this trial involved 31 children in total — 16 who received a treatment called TA-650, and 15 who received a comparison treatment called polyethylene glycol-treated human immunoglobulin (referred to as VGIH). The trial was looking at how these two treatments compared in children with a condition called Kawasaki disease, a rare illness that causes inflammation in blood vessels. The main thing the trial measured was how many children's fevers came down within 48 hours of starting treatment. It also tracked how long fevers lasted and whether children developed any changes in the arteries around the heart (known as coronary artery lesions). Not all participants finished the trial — 11 out of 16 in the TA-650 group completed it, compared to 6 out of 15 in the VGIH group. The reported data shows that, for the main measurement (fever coming down within 48 hours), 75% of children in the TA-650 group met this outcome, compared to 33.3% in the VGIH group. For the secondary measurement of how long fever lasted, the reported data shows figures of around 16 hours and 13.9 hours for the TA-650 group across two reported time points, compared to around 42.2 hours and 25.9 hours for the VGIH group — though the exact meaning of these two separate time points was not further explained in the submitted data. Regarding changes in the arteries around the heart, the reported data shows 0% of children in the TA-650 group were recorded as having these changes at any of the five time points measured, while figures ranging from 0% to 20% were reported for the VGIH group across those same 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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• NCT02169219 · results posted 17 August 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 20 people, all of whom received a combination of a steroid medicine (glucocorticoids) and a drug called rituximab. The trial was looking at whether this combination could bring a blood vessel disease called AAV (ANCA-associated vasculitis) under control. Of the 20 people who started, 14 completed the study, and 6 did not complete it (the reasons were not detailed in the reported data). The reported data shows that, for the main goal — having no signs of active disease and being completely off steroids at 6 months — 14 out of 20 participants met this measure. For the secondary measures, all 20 participants were reported to have shown a "disease response" at 4 weeks (meaning no new or worsening symptoms at that early check-in point), and all 20 also met the definition of "partial remission" (a lesser level of disease control) at some point during the study. The same 14 participants who met the primary goal were also reported to have maintained that level of control throughout the full study period without any flares (disease flare-ups). The reported data also shows that 2 participants experienced what were classified as minor flares, and 5 participants experienced more significant flares during the study period. It is worth noting that this was a small, single-group trial with no comparison group, so all numbers reflect only the group that received the combination 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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• NCT00278512 · results posted 2 August 2018

  According to the results reported on ClinicalTrials.gov, this trial (NCT00278512) enrolled 7 participants in total. All 7 were assigned to receive an autologous stem cell transplant (where a person's own stem cells are collected and returned to them after treatment), while no participants were enrolled in the allogeneic stem cell transplant group (where stem cells come from a donor). The trial's primary focus was measuring survival — that is, how many participants were still alive. The reported data shows that 6 of the 7 participants in the autologous transplant group completed the study, with 1 participant not completing it. For the primary outcome of survival, the reported figure was 6 participants in the autologous group. Because no participants were enrolled in the allogeneic transplant group, no data was reported for that group across any measure. It is worth noting that this was a very small study, and no additional outcome details — such as timeframes for survival or reasons for non-completion — were included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01663623 · results posted 17 April 2018

  According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called belimumab (given at a dose of 10 mg/kg) compared to a placebo (a dummy treatment with no active ingredient) in people with a condition involving blood vessel inflammation known as vasculitis. A total of 105 people took part — 52 in the placebo group and 53 in the belimumab group. The trial was mainly measuring how long it took for participants to experience a "relapse," meaning a return or worsening of their condition. The reported data shows that for the primary outcome — time to first relapse — the result was recorded as "NA" (not available) for both groups. According to the trial's own explanation, this happened because too few relapses occurred during the study period to calculate a meaningful figure. For one of the secondary outcomes, the trial counted how many participants experienced a "major relapse" (defined as having at least one serious flare-up based on a specific scoring tool). The reported data shows that zero participants in the placebo group and one participant in the belimumab group had a major relapse during the double-blind phase of the study. It is also worth noting that, of those who started the trial, 12 people in the placebo group and 20 people in the belimumab group did not complete the study, though the reasons for this are not detailed in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01272830 · results posted 31 January 2018

  According to the results reported on ClinicalTrials.gov, this trial looked at a supplement called Oral Apatone®B compared to a placebo (a dummy pill with no active ingredient) in people with knee pain. A total of 51 people took part — 25 in the Apatone®B group and 26 in the placebo group. Not everyone finished the trial: 17 people in the Apatone®B group and 21 in the placebo group completed it. The main thing being measured was self-reported knee pain, using a scale of 0 to 100 where a higher number means worse pain. Several secondary measurements were also taken, including two knee assessment scores (the HSS and KSS scoring systems, where higher scores are generally better) and two biological markers measured from fluid taken from the knee joint. The reported data shows that at the start of the trial, the Apatone®B group had an average pain score of 57 and the placebo group had 46.8. By the end, both groups reported lower pain scores — 39.7 for the Apatone®B group and 39.1 for the placebo group. For the knee assessment scores, the reported data shows the Apatone®B group's HSS pain-walking score went from 5.9 to 9.1, while the placebo group went from 6.9 to 7.9. The overall HSS score went from 69.6 to 76.6 in the Apatone®B group and from 71.9 to 74.5 in the placebo group. The KSS score went from 56.2 to 65.3 in the Apatone®B group and from 59.0 to 63.0 in the placebo group. For the biological markers measured in knee fluid, the Apatone®B group's TGF-Beta levels (a protein in the joint fluid — lower is considered a better result) went from 3,197.4 to 2,572.2 pg/mL, while the placebo group went from 2,089.2 to 1,572.2 pg/mL. Deoxypyridinoline levels (another joint fluid marker where lower is considered better) went from 8.0 to 6.4 nmol/L in the Apatone®B group and from 5.9 to 6.1 nmol/L 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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• NCT02020889 · results posted 26 January 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 136 people with a condition called EGPA (a rare disease involving inflammation of blood vessels), with 68 people randomly assigned to receive mepolizumab 300mg and 68 assigned to receive a placebo (an inactive treatment). The trial ran for 52 weeks and was mainly measuring how long participants spent in "remission" — a state where their disease activity score was at zero and their steroid dose (prednisolone/prednisone) was very low — as well as whether participants were in remission at two specific points in time (weeks 36 and 48). The reported data shows that, for the main outcome of time spent in remission with a very low steroid dose (4mg/day or less), 55 out of 68 placebo participants spent zero weeks in remission, compared with 32 out of 68 in the mepolizumab group. At the other end of the scale, 9 mepolizumab participants spent 36 weeks or more in remission, compared with 2 in the placebo group. For the second main outcome — being in remission at both weeks 36 and 48 — the reported data shows 22 out of 68 mepolizumab participants met this measure, compared with 2 out of 68 placebo participants. The reported secondary outcomes also described several other measurements. Regarding relapses, 38 out of 68 mepolizumab participants and 56 out of 68 placebo participants experienced at least one relapse during the study period. Looking at steroid doses in the final four weeks of the trial, 12 mepolizumab participants were taking zero steroids compared with 2 in the placebo group, while 28 mepolizumab participants were still taking more than 7.5mg per day compared with 45 in the placebo group. Additionally, 13 mepolizumab participants achieved remission within the first 24 weeks and stayed in remission for the rest of the study, compared with 1 placebo participant. 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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• NCT01613599 · results posted 17 August 2016

  According to the results reported on ClinicalTrials.gov, this trial involved 97 participants who all received the drug rituximab. Of those, 72 completed the study and 25 did not finish. The trial was set up to track how often certain serious medical events occurred in people receiving rituximab — including serious infections, reactions during infusions, heart-related events, blood vessel-related events, and cancer diagnoses. There was only one group in this study, so no comparison was made to a placebo or different treatment. The reported data shows that the main outcome being measured was the rate of serious infections — those being infections severe enough to require hospitalisation or treatment through a drip (intravenous antibiotics or antifungals). The reported rate was 7.11 serious infection events per 100 patient-years (a way of accounting for how long participants were followed up). For the secondary outcomes, the reported rate of serious heart-related events was 5.03 per 100 patient-years, and serious blood vessel-related events were reported at 2.37 per 100 patient-years. Cancer diagnoses (not counting common skin cancers) were reported at a rate of 0.89 per 100 patient-years. Importantly, the reported data shows that 0% of participants experienced a serious reaction during or within 24 hours of a rituximab infusion, and 0% experienced any serious adverse event during or within 24 hours of an infusion. 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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• NCT00430755 · results posted 18 December 2015

  According to the results reported on ClinicalTrials.gov, this trial involved 98 people who were inpatients (patients already admitted to hospital) who needed to have their medical history recorded. The trial was looking at whether a computer-assisted history-taking tool could pick up medical problems — such as drug allergies or past bad reactions to medicines — that weren't captured when a doctor took the history in the usual way. Of the 98 people who started the study, 45 completed it and 53 did not complete it; the reasons for not completing were not reported in the data provided. The reported data shows that the primary outcome being measured was the number of medical problems identified by the computer-assisted history that were *not* identified through the doctor-taken history. According to the results reported on ClinicalTrials.gov, the figure recorded for this outcome was 98 medical problems. No further breakdown of this number — such as what types of problems were found or how they were distributed across participants — was included in the submitted results data. It is worth noting that the data as submitted is limited, and no secondary outcome measures were reported in the structured results provided. Any additional details beyond what is described here were not reported in the data available 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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• NCT00760435 · results posted 13 November 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 196 children in total — 98 in the infliximab group and 98 in the placebo (dummy treatment) group. The vast majority completed the study: 94 in the infliximab group and 93 in the placebo group. The trial was looking at whether adding infliximab to a standard treatment called IVIG (an infusion of antibodies given through a drip) made a difference for children with Kawasaki disease, a condition that causes inflammation in blood vessels. The main thing being measured was how many children still had a fever 24 hours after their IVIG infusion finished. The reported data shows that the same number of children in each group — 11 out of 98 — still had a persistent or returning fever 24 hours after the IVIG infusion. For the secondary measures, the infliximab group had a reported median of 1 day of fever after treatment over the six-week study period, compared with 2 days in the placebo group. A blood marker of inflammation called C-reactive protein (CRP) — a substance the body produces when it is inflamed — changed by an average of −6.6 mg/dL from the starting level in the infliximab group and −3.6 mg/dL in the placebo group, meaning both groups showed a reduction. Finally, the trial measured changes in a key heart artery (the left anterior descending coronary artery) using a standardised size score adjusted for body size; the reported change from the starting measurement was −0.605 in the infliximab group and −0.313 in the placebo group, with a reduction in this score indicating a move toward a more typical artery size. 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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• NCT00162032 · results posted 6 December 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 445 children and teenagers with Kawasaki disease — a condition that can affect the heart's blood vessels. There were 329 children aged 4–11 and 116 adolescents aged 12–16. The trial was measuring whether a type of heart scan called Cardiolite MPI (a nuclear imaging scan that looks at blood flow in the heart at rest and during stress) could identify which young patients were at higher or lower risk of experiencing a cardiac event over time. Of those who started, 324 children and 114 adolescents completed the study. The reported data shows that among participants whose scans were classed as "normal" (lower risk), around 4.1% of children and 3.3% of adolescents went on to experience a cardiac event during follow-up. Among those whose scans were classed as "abnormal" (higher risk), the reported figures were higher — around 11.5% of children and 23.3% of adolescents. Regarding a smaller group who also had a coronary angiography (an X-ray of the heart's arteries) for comparison, the reported data shows the scan correctly identified disease in about 35% of cases where disease was present (sensitivity), and correctly identified no disease in about 62% of cases where disease was absent (specificity). When it came to the most serious events — heart attack or cardiac death — the reported data shows zero participants in any group experienced these outcomes during the study period. Over a 6-month follow-up, the number of participants who had any cardiac event was reported as 3 children and 1 adolescent with normal scans, and 3 children and 2 adolescents with abnormal scans. 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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• NCT00468208 · results posted 26 November 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 20 adults who all received the same treatment — a medicine called abatacept — for a condition called Wegener's granulomatosis (a type of autoimmune disease that causes inflammation of blood vessels). All 20 participants completed the study, and none dropped out. Because everyone received the same treatment with no comparison group, this was what is known as an "open-label" trial, meaning both the participants and researchers knew what was being given. The study was primarily looking at what side effects or unwanted events occurred, and also tracked whether participants' disease activity changed over time. The reported data shows that, out of 20 participants, 16 experienced some kind of adverse event (an unwanted or unexpected health event). Breaking that down further, the data lists: 7 participants had infections, 16 had infusion reactions (reactions during or around the time the medicine was given by drip), 14 had changes in blood cell counts (cytopenias), 1 had raised liver enzyme levels, 1 had a skin reaction, and 4 had stomach or gut-related side effects. It is worth noting that the total number of adverse event categories across the reported measurements adds up to more than 20, which means some participants experienced more than one type of event. No cases of malignancy (cancer) were reported in the data. For the secondary outcomes — which looked at disease activity using a scoring tool called BVAS/WG, where a score of 0 means no active disease — the reported data shows that 16 out of 20 participants reached remission (a score of 0), and 18 out of 20 showed some improvement in their score. However, 3 participants experienced a relapse, meaning their disease activity score rose again after they had reached remission. Fourteen participants reached the study's common closing date. 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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• NCT00264381 · results posted 18 November 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 72 people in total — 35 in a group receiving ibuprofen (800 mg, three times a day) and 37 in a group receiving dalteparin (a type of blood-thinning injection). All 72 participants completed the trial. The study was looking at whether blood clots in the veins (a condition called venous thromboembolism, or VTE) got worse over time, and whether clots spread further (called thrombosis progression). Participants were checked at 14 days and again at 3 months, using ultrasound and other imaging tests. Pain levels were also tracked using a simple 0–10 scale. The reported data shows that for the main outcome measured at 14 days, 4 participants in the ibuprofen group showed signs of clot progression on ultrasound, compared with 0 in the dalteparin group. At the 3-month check, 6 participants in the ibuprofen group and 4 in the dalteparin group had recorded clot-related events (such as clot extension or a clot travelling to the lungs). For a separate part of this 3-month outcome, 0 participants in the ibuprofen group and 1 in the dalteparin group had a recorded event. For pain, both groups reported a similar reduction on the 0–10 scale by day 14 — approximately 2.3 points down in the ibuprofen group and 2.2 points down in the dalteparin group. The reported data also shows that, across the entire 3-month follow-up period, zero participants in either group experienced a major or minor bleeding event that was recorded as related to their treatment. These figures are as submitted by the trial sponsor and no additional detail was reported beyond what is described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00670540 · results posted 3 May 2012

  According to the results reported on ClinicalTrials.gov, this trial — called OPTIMEV — enrolled 8,256 participants in total, with 4,931 completing the study and 3,325 not completing it. The trial was an observational study, meaning it watched and recorded what happened to participants over time rather than testing a specific new treatment. It was tracking people who either had, or were at risk of, a condition called venous thromboembolism (VTE) — which is when blood clots form in the veins. The study followed participants to record whether they developed blood clots, bleeding, heart-related events, cancer, or died during the follow-up period. The reported data shows that among the participants tracked, 8.94% developed a new or returning venous blood clot during the follow-up period. For the secondary measures — other things the study was recording — 3.00% experienced a major bleeding event, and 6.98% developed a cardiovascular event (a problem involving the heart or blood vessels). The reported data also shows that 4.10% of participants were recorded as developing cancer during the follow-up, and 17.0% died from any cause over the course of the study. Additionally, 52.23% of participants were reported to have been prescribed an anticoagulant medication (a blood-thinning medicine) at some point during the study. It is important to understand that these figures simply describe what was observed and recorded across this particular group of participants — they do not tell us whether any treatment caused or prevented these events. The reported data does not allow conclusions to be drawn about whether any individual person would experience similar outcomes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

• NCT00029107 · results posted 3 April 2012

  According to the results reported on ClinicalTrials.gov, this trial involved 24 people in total — 12 in a group called "Immediate Treatment" and 12 in a group called "Standard Therapy." All 24 participants completed the trial, with none dropping out. The trial was measuring the difference in remission rates — meaning the proportion of people whose condition was no longer active — between the two groups at six months after joining the study. The reported data shows that at the six-month mark, 83% of participants in the Immediate Treatment group were in remission, compared with 8% of participants in the Standard Therapy group. These figures represent the single primary outcome measure that was reported for this trial. No secondary outcome measures appear to have been submitted in the data available on ClinicalTrials.gov. It is worth noting that this was a very small trial — just 12 people in each group — which means these percentages are based on a limited number of individuals. 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 ↗

• NCT00104299 · results posted 25 August 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 197 people — 99 in the rituximab group and 98 in a control group receiving conventional therapy — to study a condition called ANCA-associated vasculitis (an illness where the body's immune system attacks blood vessels). The main thing the trial was measuring was whether participants reached "disease remission" at six months, meaning their disease activity score (measured on a scale of 0–63, where 0 means no active disease) had dropped to zero and they had successfully finished tapering off steroid medication. The reported data shows that in the rituximab group, 63 out of 99 participants met the remission measure at six months, compared with 52 out of 98 in the control group. A closely related secondary measure — which used a slightly different counting method — reported 62 participants in the rituximab group and 51 in the control group reaching this point. For how long remission lasted, the rituximab group's median duration was reported as 246 days and the control group's as 168 days, though some related figures within this measure were not reported in the data. The time it took to first reach a disease score of zero was similar between groups — a median of around 30 days for rituximab and 29 days for the control group, with longer timepoints also recorded but not showing large differences between groups. The reported data also tracked a number of specific adverse events (unwanted health events). Two deaths were recorded in each group. Grade 3 or higher infections (serious infections) were reported in 7 rituximab participants and 23 control group participants. Hospitalisations related to the disease or treatment were reported for 18 rituximab participants and 16 control participants. Several other event types — including malignancy (cancer), venous blood clots, and others — were also tracked, with small numbers recorded in both groups; the full breakdown across all individual event categories was not clearly separated in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

• NCT00271570 · results posted 29 December 2009

  According to the results reported on ClinicalTrials.gov, this trial enrolled 24 children in total — 12 in each of two groups. All 24 children completed the study with no drop-outs. The trial was looking at children with Kawasaki disease (an inflammatory condition affecting blood vessels) who had not responded to a standard treatment called IVIG. One group received a second dose of IVIG, while the other group received a different medicine called infliximab. The trial was measuring two things: the number of unwanted medical events (called adverse events) that occurred in each group, and how infliximab moved through the body over time in the infliximab group. The reported data shows that the IVIG group recorded 2 adverse events, while the infliximab group recorded 3 adverse events during the study period. For the second measurement — how infliximab was absorbed and cleared by the body over time — the trial tracked blood concentrations of infliximab at several points: before the infusion, then at 2 hours, 24 hours, 1 week, 2 weeks, and 4 weeks after. The reported data shows that the overall "area under the curve" figure (a way of summarising the total amount of the drug present in the blood across all those time points) was 619 micrograms×day/mL for the infliximab group. As expected, this figure was zero for the IVIG group, since infliximab was not given to that group. It is worth noting that with only 12 children in each group, this was a very small study. The reported data shows what was measured and recorded, but no broader conclusions about the medicine should 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.

  View reported results on ClinicalTrials.gov ↗

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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.