Efficacy and Safety of Rituximab Combined With Telitacicept for ANCA-associated Vasculitis in a Prospective Randomized Controlled Study

What this Trial Is About

Researchers are evaluating the remission rate in patients with ANCA-associated vasculitis who receive Rituximab combined with Telitacicept for remission induction, followed by Telitacicept alone for maintenance. This prospective, randomized, open-label, single-center clinical trial aims to study the effectiveness of Telitacicept in reducing relapse rates by comparing it to a placebo while maintaining remission. The study is inspired by prior work showing Rituximab's role in remission induction and Telitacicept's potential based on its use in other rheumatic diseases. Participants with active ANCA-associated vasculitis will first receive Rituximab and glucocorticoids to induce remission. Then, they will be randomly assigned to receive either weekly injections of 80 mg Telitacicept or a placebo for 12 months, alongside a tapered glucocorticoid regimen following established guidelines. This design includes two groups: one receiving Telitacicept and the other receiving its placebo, both combined with remission induction treatment. The study period extends over 24 months to assess outcomes. During participation, patients will be monitored for relapse timing, remission duration, and sustained remission at 12 and 24 months. Researchers will assess adverse events, disease progression to end-stage renal disease, and changes in ANCA status through regular clinical evaluations and laboratory tests. The total follow-up period is 24 months, during which safety and effectiveness data will be collected to better understand Telitacicept's role in maintaining remission for ANCA-associated vasculitis.

Efficacy and Safety for Rituximab Combined With Telitacicept in the Treatment of ANCA-associated Vasculitis (TTCAAVREM)