Plochingen

Researchers are conducting the Avacostar PASS, a multi-national, non-interventional prospective cohort study to gather data on patients with active severe ANCA-associated vasculitis (AAV). The study compares two groups: patients treated with avacopan and those treated with cyclophosphamide or rituximab-based induction regimens without avacopan. The goal is to evaluate the incidence of specific medical events of special interest (MESIs) over a long-term period. The study is planned to last up to 7 years, including about 3 years for recruitment. Participants will be enrolled in Germany, the United Kingdom, and possibly other countries depending on avacopan availability and suitability. Patients starting induction treatment with avacopan or standard care within 6 months prior to enrollment may join the study. Data will be collected prospectively, with some retrospective data allowed if needed. Follow-up will continue for each patient until 4 years after the last participant is enrolled, with periodic data collection at routine clinic visits. During the study, researchers will collect data on participants' medical status, treatment, and safety events to monitor the incidence of MESIs. The primary outcome focuses on safety monitoring related to avacopan use in AAV. Participants will be observed regularly through their usual clinical care visits, ensuring ongoing assessment of treatment effects and safety over several years.