Efficacy and Safety of Telitacicept Combined with Azathioprine Compared to Azathioprine Alone for Remission Maintenance in ANCA-associated Vasculitis

What this Trial Is About

Researchers are studying ANCA-associated vasculitis (AAV), a condition that involves cycles of relapse and remission, to compare the remission rates between two treatments for maintaining remission. This trial evaluates Telitacicept combined with azathioprine versus azathioprine alone for maintaining remission in AAV patients who have achieved remission after induction treatment with Rituximab. The study is a prospective, randomized, open-label, controlled trial conducted at a single center, aiming to reduce relapse rates in AAV maintenance therapy. Participants will be randomly assigned to one of two groups: one group receives azathioprine tablets at 100 mg daily for 12 months along with prednisone at a dose tapered to no more than 10 mg daily; the other group receives Telitacicept 160 mg weekly by subcutaneous injection combined with azathioprine 100 mg daily and similarly tapered prednisone. All patients will also take TMPco tablets twice daily during the study unless contraindicated or intolerant. The prednisone dose will be reduced during the study while remission is maintained. During the 12-month study period, researchers will monitor patients for the time of first relapse, the severity of any relapses, sustained remission rates, adverse events, progression to end-stage renal disease, and complications related to AAV. Patients will undergo regular evaluations including clinical assessments and laboratory monitoring. The study will help determine how adding Telitacicept to azathioprine affects the maintenance of remission in AAV patients compared to azathioprine alone.

Efficacy and Safety for Telitacicept in the Remission Maintenance Treatment of ANCA-associated Vasculitis (TTCAZAREM)