Actively Recruiting
Efficacy and Safety for Rituximab Combined With Telitacicept in the Treatment of ANCA-associated Vasculitis (TTCAAVREM)
Led by Chinese SLE Treatment And Research Group · Updated on 2023-07-27
40
Participants Needed
1
Research Sites
183 weeks
Total Duration
On this page
Sponsors
C
Chinese SLE Treatment And Research Group
Lead Sponsor
P
Peking Union Medical College Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 combined with Rituximab in remission-induction and Telitacicept alone in remission-maintain treatment.
CONDITIONS
Official Title
Efficacy and Safety for Rituximab Combined With Telitacicept in the Treatment of ANCA-associated Vasculitis (TTCAAVREM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 65 years, any gender
- Newly diagnosed or relapsing granulomatosis with polyangiitis or microscopic polyangiitis meeting 2022 ACR/EULAR criteria
- Severe active ANCA-associated vasculitis according to 2021 ACR/vasculitis foundation definition
- PR3-ANCA-positive at diagnosis or during disease course
You will not qualify if you...
- Previous Rituximab treatment stopped due to adverse events or intolerance
- Presence of other autoimmune diseases
- Severe liver dysfunction (2-fold elevation of normal upper limit or Child grade III), heart failure, or end-stage renal disease with eGFR <30 ml/min
- Pregnant or planning pregnancy within next 2 years
- Uncontrolled severe hypertension, diabetes, active bacterial or fungal infection
- Active hepatitis virus infection or active mycobacteria infection
- Malignancy
- Ineligibility as judged by principal investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, China, 100730
Actively Recruiting
Research Team
Y
Yunjiao Yang, MD
CONTACT
H
Hanqi Wang, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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