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Can extra rituximab keep vasculitis at bay?

NCT ID NCT02433522

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

97 people

The number who actually took part.

Started

Mar 2015

Finished

Aug 2018

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 years and older

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

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

  • Hopital cochin

    Paris, 75014, France