This clinical trial is focused on studying a disease called granulomatosis with polyangiitis, which is sometimes known as Wegener’s disease. This condition is a type of inflammation that affects blood vessels and can lead to damage in various organs. The study is specifically looking at cases where the disease is associated with a protein called PR3-ANCA and has relapsed, meaning it has returned after treatment.
The treatment being tested in this study is a medication called obinutuzumab, which is also known by its code name RO5072759. Obinutuzumab is given as an infusion, which means it is administered directly into the bloodstream through a vein. The purpose of the study is to see how effective obinutuzumab is in helping patients achieve remission, which means the disease becomes inactive or less severe. The study will also look at whether patients can stop taking steroids, a type of medication often used to reduce inflammation, after completing a gradual reduction in their dose.
Participants in the study will receive obinutuzumab infusions and will be monitored over a period of time to see how their condition responds. The study will last for about 12 months, with key assessments at 6 months and 12 months. Researchers will track the number of patients who achieve remission, any side effects experienced, and other health outcomes. The goal is to gather information on the safety and effectiveness of obinutuzumab for treating relapsing granulomatosis with polyangiitis.
France 