Avacostar - Post Authorization Safety Study to Evaluate Safety Events in Patients Treated With Avacopan for ANCA-associated Vasculitis

What this Trial Is About

This research aims to collect data from patients with active severe ANCA-associated vasculitis AAV, focusing on those treated with avacopan and those treated with cyclophosphamide or rituximab-based induction regimens without avacopan. The study is non-interventional, multinational, and prospective, lasting up to 7 years, including about 3 years for recruitment. Its main goal is to evaluate the incidence of specific safety events in patients starting avacopan treatment. The study will include two groups one with approximately 250 adults treated with avacopan, and another with about 250 adults receiving standard care using cyclophosphamide or rituximab without avacopan. Patients who began treatment within 6 months prior to enrollment or those starting treatment at enrollment will be included. Follow-up visits will occur periodically during routine clinic visits until 4 years after the last patient enrolls. Participants will be monitored through routine clinical visits, where data on safety events, adverse events, and various laboratory markers will be collected. The study will assess changes over time in kidney function, immune markers, and other blood tests. Researchers will also track flare occurrences, medication use, and safety outcomes over the entire study period, which may last up to 7 years.

Avacostar - (PASS)