Obinutuzumab for Remission Induction in Patients With Relapsing PR3-ANCA Granulomatosis With Poly… (NCT06940661) | Clinical Trial Compass
RecruitingPhase 2
Obinutuzumab for Remission Induction in Patients With Relapsing PR3-ANCA Granulomatosis With Polyangiitis
France33 participantsStarted 2025-12-19
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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).
Exclusion Criteria
* 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
* Patients treated with cyclophosphamide within the last 6 months before inclusion
* Patients with severe cardiac failure defined as class IV in New York Heart Association
* Subject known to be seropositive for human immunodeficiency virus (HIV), hepatitis B (included history of previous infection) or hepatitis C
* Patients with active cancer or recent cancer (\< 5 years), except basocellular carcinoma and prostatic cancer of low …
What they're measuring
1
the percentage of patients who achieved clinical and serological remission at week 24 (month 6)