Status:
RECRUITING
Efficacy and Safety for Telitacicept in the Remission Maintenance Treatment of ANCA-associated Vasculitis (TTCAZAREM)
Lead Sponsor:
Chinese SLE Treatment And Research Group
Conditions:
ANCA-associated Vasculitis
Maintenance Therapy
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
Background: The basic theme of AAV is relapse and remission. The maintenance therapy of AAV aimed to reduce or prevent relapse is very challenge. Although many medications have been used for the maint...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05965284
Start Date
March 9 2023
End Date
December 31 2026
Last Update
July 28 2023
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730