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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT04127747 |
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Date of registration:
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14/10/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy of Individualized Rituximab in Maintaining Remission of Moderate and Severe Systemic Lupus Erythematosus
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Scientific title:
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A Multicenter, Randomized Controlled Clinical Study About Efficacy and Safety of Standard Dose and Individualized Dose of Rituximab in Maintaining Remission in Patients With Moderate to Severe Systemic Lupus Erythematosus |
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Date of first enrolment:
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August 18, 2020 |
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Target sample size:
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110 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT04127747 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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China
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Contacts
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Name:
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Jing Xue |
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Address:
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Telephone:
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13858121751 |
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Email:
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jingxue@zju.edu.cn |
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Affiliation:
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Name:
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Hongwei Du |
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Address:
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Telephone:
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Email:
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Affiliation:
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Jinhua Central Hospital |
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Name:
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Wenfeng Tan |
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Address:
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Telephone:
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Email:
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Affiliation:
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The people's hospital of Jiangsu province |
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Name:
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Zhichun Liu |
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Address:
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Telephone:
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Email:
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Affiliation:
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The second affiliated hospital of Suzhou University, school of medicine |
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Name:
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Hongzhi Wang |
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Address:
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Telephone:
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Email:
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Affiliation:
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The First Hospital of Jiaxing |
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Name:
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Xiudi Wu |
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Address:
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Telephone:
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Email:
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Affiliation:
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The first hospital of Ningbo |
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Name:
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Jing Xue |
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Address:
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Telephone:
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13858121751 |
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Email:
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jingxue@zju.edu.cn |
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Affiliation:
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Name:
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Yongmei Han |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sir Run Run Shaw Hospital |
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Name:
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Fei Han |
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Address:
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Telephone:
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Email:
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Affiliation:
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Zhejiang University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Age, 18-65 years old, weight = 40 kg, sex unlimited.
2. Clearly diagnosed with systemic lupus erythematosus.
3. There was at least one BILAG B or above score in the kidney, blood system and nervous
system.
4. 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).
5. 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.
6. Subjects are willing to participate in this study and sign informed consent
voluntarily.
7. Prospective subjects agreed to use effective contraception throughout the study
period.
Exclusion Criteria:
1. Abnormal liver function: ALT or AST >2ULN,or ALP or TBil >1.5ULN
2. Severe cardiopulmonary disease;
3. Severe blood system disease
4. Patient with malignant tumor;
5. 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 ;
6. Pregnant patients or patients with recent fertility requirements;
7. Received cyclophosphamide treatment within 30 days before random;
8. For any other reason, the investigator believes that it is inappropriate to
participate in the trial.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Autoimmune Diseases
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Intervention(s)
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Drug: Individualized dose of rituximab
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Drug: Standard dose of rituximab
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Primary Outcome(s)
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Disease recurrence rate within 24 months.
[Time Frame: 24 months]
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Secondary Outcome(s)
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Times of use of rituximab in 2 years
[Time Frame: 24 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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