Actively Recruiting
Efficacy and Safety for Telitacicept in the Remission Maintenance Treatment of ANCA-associated Vasculitis (TTCAZAREM)
Led by Chinese SLE Treatment And Research Group · Updated on 2023-07-28
40
Participants Needed
1
Research Sites
199 weeks
Total Duration
On this page
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 compare the remission rate of patients treated with Telitacicept combined with azathioprine and azathioprine alone in remission-maintenance treatment of AAV.
CONDITIONS
Official Title
Efficacy and Safety for Telitacicept in the Remission Maintenance Treatment of ANCA-associated Vasculitis (TTCAZAREM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients age 18 to 65 years, both genders can be included.
- Newly diagnosed or relapsing granulomatosis with polyangiitis or microscopic polyangiitis meeting 2022 ACR/EULAR classification criteria.
- In complete remission after combined treatment with glucocorticoids and Rituximab, defined as a Birmingham Vasculitis Activity Score of 0 and prednisone dose no more than 10 mg daily.
- ANCA-positive at diagnosis or during disease course.
You will not qualify if you...
- Patients with TPMT gene mutation.
- Patients previously treated with azathioprine who relapsed.
- Patients previously treated with azathioprine who stopped due to adverse events or intolerance.
- Patients planning pregnancy within the next 1.5 years.
- Patients with severe liver dysfunction, heart failure, or end-stage renal disease (eGFR <30 ml/min).
- Patients with uncontrolled severe hypertension, diabetes, or active bacterial or fungal infection.
- Patients with active hepatitis virus or mycobacteria infection.
- Patients with other autoimmune diseases.
- Patients with malignancy.
- Patients judged ineligible by principal or site investigators.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
Y
Yunjiao Yang, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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