Trial 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
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.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 36958796) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Vasculitis Trial, Completed
Who may be able to join
AI generated eligibility 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
Who might be able to join this trial:
- You have been diagnosed with a specific type of vasculitis (blood vessel inflammation) called granulomatosis with polyangiitis or microscopic polyangiitis.
- A blood test has shown (now or in the past) the presence of certain antibodies linked to this condition, called PR3 or MPO-ANCA.
- Your condition has come back (relapsed) after you previously achieved remission, and you had already received at least 3 months of treatment with steroids plus another immune-suppressing medication (such as cyclophosphamide, methotrexate, rituximab, or mycophenolate mofetil).
- You are able and willing to provide written consent to take part in the trial.
Who may not be able to join:
- You are under 15 years old (or under 18 at hospitals that do not treat younger patients).
- You have received certain immune-suppressing or biological medicines recently — for example, rituximab or similar drugs in the past 6 months, alemtuzumab or ATG in the past 12 months, or certain other treatments such as IVIg, infliximab, or plasma exchange in the past 3 months.
- You have taken any experimental drug within the past 28 days (or longer, depending on the drug).
- You have another serious or uncontrolled health condition (unrelated to your vasculitis) that the trial doctor feels would make participation unsafe.
- You have another condition where your immune system attacks your body, such as lupus, Churg-Strauss syndrome, anti-GBM disease, or cryoglobulinaemic vasculitis.
- You have a condition (such as poorly controlled asthma, COPD, psoriasis, or inflammatory bowel disease) that is likely to require long-term steroid treatment, which could interfere with the trial's treatment plan.
- You have had a severe allergic or anaphylactic reaction to certain types of antibody-based medicines in the past.
- You are known to be HIV positive, or you have a history of hepatitis B or hepatitis C infection.
- You have active tuberculosis, a known active infection, or untreated hidden (latent) tuberculosis within the past 12 months.
- You have had a cancer diagnosis within the past 5 years or have any ongoing cancer — with the exception of certain fully removed skin cancers or treated cervical pre-cancer.
- You are pregnant or not using adequate contraception (if you could become pregnant).
- You are currently breastfeeding.
- Your blood test results show that your bone marrow is not producing enough blood cells (low white blood cell count, low haemoglobin, or low platelets).
- Your blood test results show significant problems with liver function or pancreas enzymes, unless these are caused by your vasculitis itself.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: David Jayne, Cambridge University Hospitals NHS Foundation Trust
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
3 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Relapse-free Survival
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.