Status:
RECRUITING
Efficacy and Safety for Rituximab Combined With Telitacicept in the Treatment of ANCA-associated Vasculitis (TTCAAVREM)
Lead Sponsor:
Chinese SLE Treatment And Research Group
Collaborating Sponsors:
Peking Union Medical College Hospital
Conditions:
ANCA Associated Vasculitis
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 investigate the remission rate of patients treated with Telitacicept combi...
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 have severe active AAV according to the 2021 ACR/vasculitis foundation definition.
- Patients have to be PR3-ANCA-positive at diagnosis or during the course of their disease.
Exclusion
- Patients who had been treated with Rituximab but had to stop due to adverse events or intolerance.
- Patients who had other autoimmune diseases.
- 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 who are pregnant or have planned for pregnancy in next 2 years.
- 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 with malignancy.
- Patients who are not eligible according to the judge of the principal investigators.
Key Trial Info
Start Date :
June 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05962840
Start Date
June 29 2023
End Date
December 31 2026
Last Update
July 27 2023
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China, 100730