ObiVas Study Overview
Introduction
ANCA-associated vasculitis (AAV) is a condition where relapses can lead to severe organ damage, necessitating prolonged immunosuppressive therapy. Rituximab, the current standard of care, may not always be effective and is linked to a high relapse risk. Obinutuzumab is a potential alternative with the ability to achieve better tissue B cell depletion and reduce relapse risk in AAV.
Methods and Analysis
The ObiVas trial is a phase II, double-blind controlled study comparing the effects of rituximab and obinutuzumab in treating AAV patients. 26 patients will be recruited to receive either rituximab or obinutuzumab alongside a tapering glucocorticoid regimen. The primary aim is to assess CD19+ B cell depletion in nasal-associated lymphoid tissue (NALT) at week 26. Safety, clinical efficacy, and impact on immune biomarkers will also be evaluated, with patients followed through to week 78.
Ethics and Dissemination
The trial will ensure informed consent from patients and results will be shared with scientific, clinical, and patient communities. NALT data analysis will begin before trial completion, with other analyses reported after completion.
Trial Registration
ISRCTN13069630
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