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 PHASE2 RECRUITING

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.

Details

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	PHASE2
Status	RECRUITING
Enrolment	48
Start date	Wed Oct 20 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Mon Oct 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Vasculitis
• Cryoglobulinemia

Interventions

• Belimumab
• Placebo

Countries

France