Efficacy Study of Two Treatments in the Remission of Vasculitis (NCT00748644) | Clinical Trial Compass
CompletedPhase 3
Efficacy Study of Two Treatments in the Remission of Vasculitis
France117 participantsStarted 2008-10
Plain-language summary
Study of the efficacy of rituximab for maintenance treatment in systemic ANCA-associated vasculitis: prospective, multicenter, controlled, randomized comparative study of rituximab versus azathioprine
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (cyclophospha…
What they're measuring
1
Number of major relapse (BVAS>10) in each group at the end of the maintenance treatment (18 months treatment + 10 months follow-up)