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)

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 STUDY (Treatment nd BElimumab in Cryoglobulinemia Associated Vasculitis)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vasculitis
• Cryoglobulinemia

Interventions

Type	Name	Description
DRUG	Belimumab	Belimumab administered subcutaneously 200mg weekly from week 1 to week 24. Both arms will have the same corticosteroid tapering scheme, with an initial dose of 30 mg/day. The following schedule of reduction of prednisone will apply to both groups as long as the disease is inactive: * 30 mg/day week (W)0-W2, * 20 mg/day W2-W4 * 15 mg/day W4-W6, * 10 mg/day W6-W8, * 5 mg/day W8-W10 Between W10-W12 the strategy for stopping glucocorticoids is left to the investigator's discretion. Stopping glucocorticoid therapy at W12. At each step, the prednisone dose will be reduced only in the absence of signs of vasculitis activity.
DRUG	Placebo	Both arms will have the same corticosteroid tapering scheme, with an initial dose of 30 mg/day. The following schedule of reduction of prednisone will apply to both groups as long as the disease is inactive: * 30 mg/day week (W)0-W2, * 20 mg/day W2-W4 * 15 mg/day W4-W6, * 10 mg/day W6-W8, * 5 mg/day W8-W10 Between W10-W12 the strategy for stopping glucocorticoids is left to the investigator's discretion. Stopping glucocorticoid therapy at W12. At each step, the prednisone dose will be reduced only in the absence of signs of vasculitis activity.

Timeline

• Start date: 2021-10-20
• Primary completion: 2025-04-20
• Completion: 2025-10-20
• First posted: 2020-11-16
• Last updated: 2024-06-26

Locations

20 sites across 1 country: France