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
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Disease recurrence rate within 24 months.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Standard dose group
干预措施: Standard dose of rituximab (Drug)
Individualized dose group
干预措施: Individualized dose of rituximab (Drug)
结局指标
主要结局
Disease recurrence rate within 24 months.
时间窗: 24 months
Evaluate the efficacy of individualized and standard dose rituximab in maintaining remission in moderate to severe SLE patients
次要结局
- Times of use of rituximab in 2 years(24 months)