Actively Recruiting
Efficacy and Safety of Telitacicept for Prevention of Flares in SLE Patients
Led by RenJi Hospital · Updated on 2024-07-03
176
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a randomized, double-blind, placebo-controlled single-center clinical trial. The aim of this study is to investigate the efficacy and safety of low-dose telitacicept for prevention of flares in SLE patients with low disease activity.
CONDITIONS
Official Title
Efficacy and Safety of Telitacicept for Prevention of Flares in SLE Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-70 years
- Diagnosed with systemic lupus erythematosus (SLE) with low disease activity (SELENA-SLEDAI score less than 8 at screening)
- Disease duration more than 3 months with no severe BILAG A score and no more than one B score
- Stable treatment regimen with fixed doses of prednisone (up to 30 mg/day), antimalarial, or immunosuppressive drugs for at least 3 months
- Signed informed consent
You will not qualify if you...
- Hepatic or renal dysfunction: ALT/AST greater than 2 times upper normal limits or GFR less than 60 ml/min
- Exposure to cyclophosphamide within 6 months before screening
- Exposure to any B cell targeted therapy (Rituximab, Belimumab, Telitacicept) within 6 months before screening
- Pregnant or lactating women
- History of malignancy within the last 5 years, except treated skin tumors or carcinoma in situ of cervix
- Active hepatitis or history of severe liver disease
- Current infections such as HIV, tuberculosis, or COVID-19 at screening
- Significant decrease in immunoglobulin level (IgG less than 5 g/L)
- Not suitable for the study as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ren Ji Hospital
Shanghai, China, 201112
Actively Recruiting
Research Team
T
Ting Li
CONTACT
S
Shuang Ye
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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