Obinutuzumab for Remission Induction in Patients With Relapsing PR3-ANCA Granulomatosis With Polyangiitis (Wegener's). Phase 2 Prospective, Open-label Study
The purpose of this study is to evaluate the efficacy and safety of obinutuzumab to induce clinical and serological remission in patients with relapsing PR3-ANCA granulomatosis with polyangiitis.
• Patient aged of 18 years or older,
• Patients with relapsing granulomatosis with polyangiitis positive for PR3-ANCA at inclusion according to the ACR/EULAR 2022 classification criteria, and/or the 2012 revised Chapel Hill Consensus Conference definition.
• Patients with an active disease defined as a Birmingham Vasculitis Activity Score (BVAS) ≥ 3,
• Patients within the first 21 days following initiation/increase of glucocorticoids at a dose ≤1 mg/kg/day (pulses of methylprednisolone before oral glucocorticoid therapy are authorized)
• Patient able to give written informed consent prior to participation in the study, - Affiliation with a mode of social security (profit or being entitled).