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)

"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."

"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."