Smart dosing of rituximab may keep rare blood vessel disease at bay
NCT ID NCT01731561
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 2 times
Summary
This study tested two ways of giving rituximab to people with ANCA-associated vasculitis, a rare disease where the immune system attacks blood vessels. All 166 participants were in remission and received rituximab either on a fixed schedule or only when certain blood markers (ANCA or CD19 cells) reappeared. The goal was to see which approach better prevents relapses over 18 months of treatment plus 10 months of 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, this could show that monitoring blood markers to guide rituximab dosing is as effective as fixed infusions, potentially reducing treatment burden.
- What could go wrong
- This is a completed phase 3 trial, but results may not apply to all patients. Rituximab carries risks like infusion reactions and increased infection risk.
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
-
166 people
The number who actually took part.
- Started
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Nov 2012
- Finished
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Apr 2016
- 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
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18 years and older
- Sex
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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: * 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. 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. * 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. * 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. * 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, unrelated to vasculitis
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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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Cochin Hospital
Paris, 75014, France
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Other studies related to the condition(s) this trial covers.
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