Status:
UNKNOWN
Efficacy of Individualized Rituximab in Maintaining Remission of Moderate and Severe Systemic Lupus Erythematosus
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Autoimmune Diseases
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Several clinical studies have shown that rituximab is safe and effective for the induction of remission in moderate to severe systemic lupus erythematosus, and has been recommended by several guidelin...
Eligibility Criteria
Inclusion
- Age, 18-65 years old, weight ≥ 40 kg, sex unlimited.
- Clearly diagnosed with systemic lupus erythematosus.
- There was at least one BILAG B or above score in the kidney, blood system and nervous system.
- After standardized treatment with high dose glucocorticoid combined with immunosuppressants such as CTX,MMF or RTX, complete or partial remission of the disease was achieved (up to 1 BILAG B score, and at least 1 BILAG A or BILAG B score less than before).
- Glucocorticoid: prednisone or the equivalent of prednisone less than or equal to 20 mg daily dose, and can be increased or decreased within 20 mg during the study.
- Subjects are willing to participate in this study and sign informed consent voluntarily.
- Prospective subjects agreed to use effective contraception throughout the study period.
Exclusion
- Abnormal liver function: ALT or AST \>2ULN，or ALP or TBil \>1.5ULN
- Severe cardiopulmonary disease;
- Severe blood system disease
- Patient with malignant tumor;
- Concurrent infection：Subjects were hospitalized for infection or treated with parenteral antibiotics within 30 days before random; Hepatitis B surface antigen positive or active hepatitis, not treated with hepatitis B antivirus; T-SPOT positive or active tuberculosis, not treated with antituberculous therapy; Any positive in HCV-Ab, HIV-Ab, or TPPA ;
- Pregnant patients or patients with recent fertility requirements;
- Received cyclophosphamide treatment within 30 days before random;
- For any other reason, the investigator believes that it is inappropriate to participate in the trial.
Key Trial Info
Start Date :
August 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04127747
Start Date
August 18 2020
End Date
July 1 2023
Last Update
November 17 2020
Active Locations (1)
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1
Second affiliated hospital of zhejiang university，school of medical
Hangzhou, Zhejiang, China, 310000