drugset / Trial / NCT04629144

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)

NCT04629144

Phase 2 Unknown 48 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupDouble-blindTreatment

Summary

Cryoglobulinemia vasculitis (CV) is a systemic immune-mediated small vessel vasculitis. Rituximab proved effective on main vasculitis signs, with a complete clinical response of 65%. However, CV relapse is noted in up to 40% of patients. Following rituximab, serum Blys concentration significantly increased and may favor relapses. Tribeca is a multicentre randomized controled study comparing safety and efficacy of belimumab to placebo in non infectious cryoglobulinemia vasculitis.

Timeline

Start
2021-10-20
Primary completion
2025-04-20
Completion
2025-10-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Belimumab Monoclonal antibody 200 mg Subcutaneous