Efficacy and Safety for Telitacicept in the Remission Maintenance Treatment of ANCA-associated Vasculitis (TTCAZAREM)
A Prospective, Open-label, Controlled, Single Center Clinical Study of the Efficacy and Safety for Telitacicept in the Remission Maintenance Treatment of ANCA-associated Vasculitis
Chinese SLE Treatment And Research Group
40 participants
Mar 9, 2023
INTERVENTIONAL
Conditions
Summary
This study is a prospective, open-labelled, randomized, controlled, single-center clinical trial. The aim of this study is to compare the remission rate of patients treated with Telitacicept combined with azathioprine and azathioprine alone in remission-maintenance treatment of AAV.
Eligibility
Inclusion Criteria4
- 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 Criteria10
- 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.
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Interventions
All patients included into this study will be treated with Azathioprine tablets 100mg QD for 12 months.
Patient will be treated with Telitacicept (Taiai the commercial name) 160 mg every week subcutaneously for 12 months
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05965284