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)
Patients with MPO-positive AAV, or other vasculitis, defined by the ACR criteria and/or the Chapel Hill Consensus Conference,
Patients with vasculitis in remission of the disease defined as a BVAS < 3,
Patients with a newly-diagnosis of GPA
Patients treated with rituximab within the last 6 months before inclusion
Single group
Obinutuzumab
DrugPatient will receive 1000 milligrams intravenous (IV) infusion on week 0, week 2, week 24 and week 26. Patients will receive the same standardized glucocorticoid tapering schedule (prescribe as a standard of care management and considered as auxiliary medicinal product) Premedication for obinutuzumab infusion related reactions (considered as auxiliary medicinal products) : * 100 mg methylpredinisolone * 1000 mg paracetamol * 5 mg dexchlorpheniramine
the percentage of patients who achieved clinical and serological remission at week 24 (month 6)
The percentage of patients who achieved clinical and serological remission at week 24 (month 6), defined by: * a BVAS of 0, * a negativation of PR3-ANCA, * and successful completion of the prednisone taper
Proportion of participants experiencing adverse events and severe adverse events
The number of adverse events, expressed as adverse events according to the CTCAE toxicity grading system per patient-year at week 24 and 52 for the following adverse events combined: death (all causes), grade 2 or higher leukopenia or thrombocytopenia, grade 3 or higher infections, haemorrhagic cystitis, malignancies, venous thromboembolic events, hospitalization resulting either from the disease or from a complication due to the study treatment, infusion reactions (within 24 hours of infusion) that result in the cessation of further infusions,
Number and causes of deaths
Number and causes of deaths
Proportion of disease flares, including minor and major relapses
Proportion of participants who had vasculitis relapses (BVAS \> 0), including minor and major relapses over the 12 months study periodCD19
Proportion of participants who remain with a BVAS of 0 during the treatment period with prednisone at a dose of less than 10 mg per day
BVAS, prednisone dose
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Assistance Publique - Hôpitaux de Paris
Lead sponsor
URC-CIC Paris Descartes Necker Cochin
Collaborator
