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โ† Trials
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Efficacy and Safety of Telitacicept for Prevention of Flares in SLE Patients

RecruitingNAAges 18 Years - 70 YearsAllRenJi Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age 18-70 years; 2. SLE patients with low disease activity (SELENA-SLEDAI score\< 8 at screening ); disease duration more than 3 months๏ผ›no British Isles Lupus Assessment Group (BILAG) A and no more than one B; 3. A stable treatment regimen with fixed doses of prednisone (โ‰ค 30mg/day), antimalarial, or immunosuppressive drugs (mycophenolate mofetil/azathioprine/ciclosporin /tacrolimus/methotrexate/leflunomide) for at least 3 months; 4. Sign the informed consent. Exclusion Criteria: 1. Hepatic or renal dysfunction: alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) \> 2 times upper normal limits; GFR \< 60ml/min; 2. Exposure to cyclophosphamide within past 6 months before screening; 3. Exposure to any B cell targeted therapy (Rituximab/Belimumab/Telitacicept) within past 6 months before screening; 4. Pregnant women, lactating women; 5. History of Malignancy within the last 5 years, excluding adequately treated skin tumors (basal cell or squamous cell carcinoma) or carcinoma in situ of cervix; 6. Active hepatitis or a history of severe liver disease; 7. Current infections (HIV/tuberculosis/COVID-19, etc.) at screening; 8. A significant decrease in immunoglobulin level, IgG\<5g/L; 9. Not suitable for the study in the opinion of the investigator.
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What it tests

  • Telitacicept
  • Placebo
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Where

1 site
Ren Ji Hospital
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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