Status:
COMPLETED
Efficacy and Safety of Belimumab in SLE Patients
Lead Sponsor:
RenJi Hospital
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
Systemic lupus erythematosus (SLE) is a chronic inflammatory systemic autoimmune disease. Recurrent relapses of disease and development of long-term organ damage are two key unsolved clinical problems...
Detailed Description
Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune disease with the incidence of about 70/100,000 in China. Recurrent relapses of disease and development of long-term organ damage are...
Eligibility Criteria
Inclusion
- Age 18-70 years;
- Patients with low disease activity (score≤ 6 at screening on SLEDAI); no British Isles Lupus Assessment Group (BILAG) A and no more than one B;
- A stable treatment regimen with fixed doses of prednisone (≤ 20mg/day), antimalarial, or immunosuppressive drugs (azathioprine/mycophenolate mofetil/ methotrexate/ciclosporin/leflunomide/tacrolimus) for at least 30 days.
- Sign the informed consent;
Exclusion
- Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) \> 2 times upper normal limits;
- Creatinine clearance rate \< 60ml/min;
- Exposure to cyclophosphamide within past 6 months before screening;
- Exposure to any B cell targeted therapy (Rituximab/belimumab) within past 1 year before screening;
- History of Malignancy;
- History of herpes zoster with past 3 months before screening.
- Chronic HBV/HCV hepatitis；
- Current infections (HIV/tuberculosis)
Key Trial Info
Start Date :
March 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2022
Estimated Enrollment :
231 Patients enrolled
Trial Details
Trial ID
NCT04515719
Start Date
March 10 2021
End Date
April 10 2022
Last Update
May 14 2025
Active Locations (1)
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1
Shuang Ye, MD
Shanghai, Shanghai Municipality, China