Rituximab shows promise in preventing vasculitis relapses
NCT ID NCT00748644
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether rituximab, a targeted antibody therapy, is better than azathioprine, a standard immune-suppressing drug, at preventing relapses in people with ANCA-associated vasculitis. 117 patients who had achieved remission were randomly assigned to receive either rituximab infusions or azathioprine pills over 18 months. The main goal was to see how many had a major relapse during treatment and follow-up.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Rituximab
- What this could lead to
- If successful, rituximab could become a standard maintenance therapy to prevent relapses in vasculitis patients, reducing the need for long-term steroids.
- What could go wrong
- This is a Phase 3 trial, but results may not apply to all patients. Rituximab can cause infusion reactions and increase infection risk. The study is completed, so findings are available but not yet widely implemented.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
117 people
The number who actually took part.
- Start date
-
Oct 2008
- Finished
-
Jun 2013
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Wegener's granulomatosis Or microscopic polyangiitis complying Or kidney-limited disease With or without detectable ANCA (anti-neutrophil cytoplasmic antibodies) at the time of diagnosis or relapse, and at remission. * Who have achieved remission using a treatment combining corticosteroids and an immunosuppressive agent according to current French guideline, including corticosteroids, cyclophosphamide IV or oral (the use of another immunosuppressant is allowed, according to the current French guidelines, as well as plasma exchanges and/or IV immunoglobulins). * Interval of 1 month between the end of the immunosuppressant treatment and the randomization time * Age \> 18 years and \< 75 years when the diagnosis is confirmed. * Informed and having signed the consent form to take part in the study. Exclusion Criteria: * Other systemic vasculitis * Secondary vasculitis (following neoplastic disease or an infection in particular)· * Induction treatment with a regimen not corresponding to that recommended in France. * Patient who has not achieved remission.· * Patient who has already received a treatment by biological agents (monoclonal antibody - antiCD20 or antiTNFα). * Incapacity or refusal to understand or sign the informed consent form. * Incapacity or refusal to adhere to treatment or perform the follow-up examinations required by the study. Non-compliance· * Allergy, documented hypersensitivity or contraindication to the study medication (cyclophosphamide, corticosteroids, azathioprine, rituximab), * History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies. * Patients receiving allopurinol cannot be included if the allopurinol must absolutely be maintained. * Pregnancy, breastfeeding. Women of childbearing age must use a reliable method of contraception throughout the duration of immunosuppressive treatment up to 1 year after the last infusion of rituximab * Infection by HIV, HCV or HBV * Progressive, uncontrolled infection requiring a prolonged treatment (tuberculosis, HIV infection, etc.). * Severe infection declared during the 3 months before randomization (CMV, HBV, HHV8, HCV, HIV, tuberculosis). * Progressive cancer or malignant blood disease diagnosed during the 5 years before the diagnosis of vasculitis. Patients suffering from non-metastatic prostate cancer or those cured of a cancer or a malignant blood disorder for more than 5 years and not taking any antineoplastic agents for more than 5 years may be included. * patients presenting a systemic disease receiving protocolized treatments (azathioprine, rituximab) which could have unexpected and inappropriate side effects. * Participation in another clinical research protocol during the 4 weeks before inclusion. * Any medical or psychiatric disorder which, in the investigator's opinion, may prevent the administration of treatment and patient follow-up according to the protocol, and/or which may expose the patient to a too greater risk of an adverse effect. * No social security * Churg and Strauss syndrome * viral, bacterial or fungic or mycobacterial infection uncontrolled in the 4 weeks before the inclusion * history of deep tissue infection (fasciitis, osteomyelitis, septic arthritis)in the first year before the inclusion * History of chronic and severe or recurrent infection or history of preexisting disease predisposing to severe infection * Severe immunodepression * Administration of live vaccine in the four weeks before inclusion * severe chronic obstructive pulmonary diseases (VEMS \< 50 % or dyspnea grade III) * chronic heart failure stade III and IV (NYHA) * History of recent acute coronary syndrome
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hopital Cochin
Paris, 75014, France
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