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Can extra rituximab keep vasculitis at bay?
NCT ID NCT02433522
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looked at whether giving rituximab for 46 months instead of the usual 18 months can better prevent relapses of ANCA-associated vasculitis, a rare autoimmune disease that causes blood vessel inflammation. 97 patients who were already in remission after initial rituximab treatment were randomly assigned to receive either additional rituximab infusions or a placebo. The goal was to see if the longer treatment keeps patients relapse-free for longer.
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, this could show that longer rituximab treatment helps prevent disease relapses in people with ANCA-associated vasculitis.
- What could go wrong
- This is a small, completed Phase 3 trial with only 97 participants. Results may not apply to all patients, and longer treatment could increase infection risks.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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97 people
The number who actually took part.
- Started
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Mar 2015
- Finished
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Aug 2018
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: First, patients must have been included in MAINRITSAN 2 and in addition to meeting the criteria for inclusion and non-inclusion. MAINRITSAN 2 inclusion criteria: * Granulomatosis with Polyangiitis 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, 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, or rituximab). * Interval of 1 month between the end of the immunosuppressant treatment and the randomization time if cyclophosphamide or methotrexate were used, interval between 4 and 6 months if rituximab was used * Age \> 18 years without age limit higher when the diagnosis is confirmed. * Informed and having signed the consent form to take part in the study. and Patients must meet all of the following criteria: * In complete remission (BVAS 0) at 28 months of MAINRITSAN2 study. * Informed patient who accepted to participate in MAINRITSAN 2 and who signed the informed consent to this extension. * Randomized on the day of the evaluation of the primary endpoint of MAINRITSAN 2 during the visit M28 (last visit of the protocol). Exclusion Criteria: * Eosinophilic granulomatosis with polyangiitis (EGPA) * History of severe allergic manifestations or anaphylactic manifestations following humanized or murine monoclonal antibodies infusions * Pregnant or breast feeding women. Contraception is required for women who could be pregnant during treatment follow up and during the year following the last infusion. * Infection by HIV (positive serology), HCV (positive serology), or HBV (HBsAg positive or anti-HBc antibody positive with anti-HBs antibody negative) * Uncontrolled infection at time of inclusion in the extended follow-up study. * Other severe bacterial, viral , mycobacterial or fungal infection(s), occurring within the last 3 months before of randomization. A severe infection is defined by the hospitalization, a life or organ threatening. * Severe chronic obstructive bronchopathy (FEV \< 50% or dyspnea stage III). * Cardiac failure, stage IV according to the NYHA classification. * Recent history of coronary artery disease (\<1 month). * Ongoing malignancy or hematologic disease within 5 years before inclusion. * Patient with severe immunodepression characterized by clinical manifestations. * Participation to another concomitant therapeutic study (except observational studies or studies without therapeutic intervention). * Psychiatric disease that may interfere with the study. * Non affiliation to a health insurance. * Uncontrolled severe cardiac disease.
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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
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Hopital cochin
Paris, 75014, France