Multicenter Randomized Double-blind Study Comparing the Efficacy and Safety of Belimumab in the Treatment of Non-infectious Active Cryoglobulinemia Vasculitis Compared to Placebo (TRIBECA)

What this Trial Is About

Cryoglobulinemia vasculitis (CV) is a systemic immune-related small blood vessel inflammation that can relapse in many patients even after treatment with rituximab, which helps most but not all. Researchers are studying whether belimumab, compared to a placebo, is safe and effective for treating non-infectious active CV. This is a phase 2 multicenter randomized controlled trial sponsored by Assistance Publique - Hôpitaux de Paris. Participants are randomly assigned to receive either belimumab or placebo injections under the skin once a week for 24 weeks. Both groups follow the same plan to gradually reduce corticosteroid (prednisone) doses over 12 weeks, starting at 30 mg per day and tapering down if the disease remains inactive. After 12 weeks, stopping corticosteroids is decided by the doctor. This study is double-blinded, meaning neither participants nor researchers know who receives belimumab or placebo. During the study, participants undergo assessments at various time points including weeks 5, 13, 25, and 48 to measure clinical response, safety, disease activity, quality of life, and laboratory markers like cryoglobulins, rheumatoid factor, and complement levels. The main outcome is the rate of complete clinical response at week 25 after corticosteroid withdrawal. Participants are monitored for infections and relapses throughout the study, which helps researchers understand the treatment's effects and safety over nearly a year.

Efficacy and Safety of Belimumab in the Treatment of Non-infectious Active Cryoglobulinemia Vasculitis Compared to Placebo. TRIBECA STUDY (Treatment nd BElimumab in Cryoglobulinemia Associated Vasculitis)