Efficacy and Safety for Telitacicept in the Remission Maintenance Treatment of ANCA-associated Vasculitis (TTCAZAREM)
ANCA-associated Vasculitis, Maintenance Therapy
About this trial
This is an interventional treatment trial for ANCA-associated Vasculitis focused on measuring ANCA-associated Vasculitis, Telitacicept, Azathioprine, Relapse rate
Eligibility Criteria
Inclusion Criteria: Patients age 18 to 65 years, both genders can be included. Patients who are newly diagnosed or relapsing granulomatosis with polyangiitis or microscopic polyangiitis must fulfill the 2022 ACR/EULAR classification criteria of GPA or MPA. Patients who are in complete remission after combined treatment with glucocorticoids and Rituximab. Remission is defined as a Birmingham Vasculitis Activity Score (BVAS version 3) of 0. And the daily dosage of prednisone are no more than 10mg (or equivalent). Patients have to be ANCA-positive at diagnosis or during the course of their disease. Exclusion Criteria: Patients with TPMT gene mutation. Patients who had been treated with either AZA but relapsed in the past. Patients who had been treated with either AZA but had to stop due to adverse events or intolerance. Patients who have planned for pregnancy in next 1.5 years. Patients with severe liver dysfunction(defined as the 2-folds elevation of normal upper limit or Child grade III), heart failure or ESRD(eGFR<30ml/min). Patients with uncontrolled sever hypertension, diabetes, active bacteria or fungal infection; Patients with active hepatitis virus infection as well as patients who have active mycobacteria infection; Patients who had other autoimmune diseases. Patients with malignancy. Patients who are not eligible according to the judge of the principal investigators or site investigators.
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Other
Experimental
Azathioprine treatment arm
Telitacicept treatment arm
Patients will be treated with Azathioprine 100mg per day for 12 months combined with prednisone no more than 10mg daily. The dosage of prednisone is tapered in the study period while sustained remission achieved. All included patients will be treated with TMPco 2 tablets per day during the study period if not contraindicated or intolerant.
Patients will be treated with Telitacicept 160mg per week combined with Azathioprine 100mg per day for 12 months combined with prednisone no more than 10mg daily. The dosage of prednisone is tapered in the study period while sustained remission achieved. All included patients will be treated with TMPco 2 tablets per day during the study period if not contraindicated or intolerant.