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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 guidelines for the induction of remission in refractory lupus with important organ involvement. However, there are few studies on the use of rituximab in the long-term maintenance and remission of the disease. There is no recognized scheme for the dose, interval and course of treatment of the drug. In this study, patients with moderate and severe systemic lupus erythematosus who achieved remission after standardized treatment were randomly divided into two groups at 1:1 and followed up every 3 months for 24 months. The basic situation and disease activity score of each subject were recorded. The recurrence rate of each observation group was calculated, the influencing factors of disease recurrence were analyzed, and a more reasonable drug use scheme was explored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard dose group | Active Comparator |
| |
| Individualized dose group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard dose of rituximab | Drug | Patients in this group will accept RTX 500mg treatment on the first day and on the 6th, 12th,18th and 24th month after that. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease recurrence rate within 24 months. | Evaluate the efficacy of individualized and standard dose rituximab in maintaining remission in moderate to severe SLE patients | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Times of use of rituximab in 2 years | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Xue | Contact | 13858121751 | jingxue@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Fei Han | Zhejiang University | Principal Investigator |
| Zhichun Liu | The second affiliated hospital of Suzhou University, school of medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second affiliated hospital of zhejiang university,school of medical | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| Individualized dose of rituximab | Drug | Patients in this group will accept RTX 500mg treatment on the first day of admission. Patients will be followed-up every 3 months, and will receive one RTX 500mg treatment, if CD19 B cell count ≥ 1%, or dsDNA titer increased (dsDNA antibody positive, and increased more than 100% compared with the previous time), or complement C3 level decreased (lower than normal value, and decreased more than 50% compared with the previous time). |
|
| Wenfeng Tan |
| The people's hospital of Jiangsu province |
| Principal Investigator |
| Xiudi Wu | The first hospital of Ningbo | Principal Investigator |
| Hongzhi Wang | Affiliated Hospital of Jiaxing University | Principal Investigator |
| Hongwei Du | Jinhua Central Hospital | Principal Investigator |
| Yongmei Han | Sir Run Run Shaw Hospital | Principal Investigator |
| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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