Status:
RECRUITING
Efficacy and Immunological Evaluation of Telitacicept and Low Dose IL2 in the Treatment of Systemic Lupus Erythematosus
Lead Sponsor:
Liu Tian
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study was to explore the clinical and immunological efficacy of Telitacicept and low dose IL-2 on systemic lupus erythematosus.
Detailed Description
Given that Telitacicept and low dose IL2 have been widespreadly applied in the treatment of systemic lupus erythematosus, this study designed a randomised, single center, prospective study to investig...
Eligibility Criteria
Inclusion
- Male or female \>18 years of age at screening visits
- Patients meet the American-European Consensus Group 2002 classification criteria of SLE.
- The patient must be informed in writing of the consent to participate in the trial and the patient is expected to be able to comply with the requirements of the study follow-up plan and other protocols.
- Dosing of antimalarials, prednisone or equivalent, cholinergic stimulants, and topical cyclosporine required to be stable for at least 4 weeks before screening and during study; maximum doses allowed:
- Hydroxychloroquine, 400 mg/day;
- Prednisone, 10 mg/day
Exclusion
- Any subject meeting any of the following criteria should be excluded:
- Laboratory abnormality: • Hb≤9 g/dl • Neutrophil 10 mg/d) within 1 month.
- Serious complications: including heart failure (≥ New York Heart Association (NYHA) class III), renal insufficiency (creatinine clearance ≤ 30 ml/min), liver dysfunction (serum Alanine transaminase (ALT) or aspartate aminotransferase (AST) greater than three times the upper limit of normal, or total bilirubin greater than Normal upper limit.
- Known allergies, hyperreactivity or intolerance of tofacitinib or its excipients.
- Have a serious infection needing hospitalization (including but not limited to hepatitis, pneumonia, bacteremia, pyelonephritis, EB virus, tuberculosis infection), or use intravenous antibiotics to treat infection in 2 months before the enrollment.
- Infection with HIV (HIV antibody positive serology) or hepatitis C (Hep C antibody positive serology). If seropositive, it is recommended to consult a doctor who has expertise in treating HIV or hepatitis C virus infection.
- Any known history of malignancy in the past 5 years (except for nonmelanoma skin cancer, non-melanoma skin cancer or cervical tumor without recurrence within 3 months after surgical cure prior to the first study preparation).
- Uncontrolled mental or emotional disorders, including a history of drug and alcohol abuse over the past 3 years, may hinder the successful completion of the study.
- Pregnant, lactating women (WCBP) are reluctant to use medically approved contraceptives during treatment and 12 months after treatment.
Key Trial Info
Start Date :
February 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05339217
Start Date
February 7 2023
End Date
July 1 2025
Last Update
April 3 2024
Active Locations (1)
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1
Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing, Beijing Municipality, China