Investigation of the Safety and Efficacy of Iguratimod in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,747
- 主要终点
- Disease Activity Score (DAS28) for Rheumatoid Arthritis (EULAR Response Criteria)
研究概览
简要总结
To investigate the safety and efficacy of the administration of Iguratimod (CRM01T) for 52 weeks in patients with rheumatoid arthritis in clinical practice
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Iguratimod
干预措施: Iguratimod (Drug)
结局指标
主要结局
Disease Activity Score (DAS28) for Rheumatoid Arthritis (EULAR Response Criteria)
时间窗: 52 weeks (0-24 weeks and 25-52 weeks)
DAS28 is a quantitative tool used to measure and monitor disease activity and treatment of rheumatoid arthritis. DAS28 uses a formula that includes the number of tender joints and swollen joints for a maximum of 28 joints. DAS28 is used to assess whether an individual participant has a significant improvement of the disease activity, compared to baseline. * Good response: Baseline DAS28 less than or equal to 3.2 (low disease activity); DAS28 Improvement \>1.2 * Moderate response: Baseline DAS28 less than or equal to 3.2; DAS28 Improvement \>0.6 and less than or equal to 1.2 * or Baseline DAS28 \>3.2 and less than or equal to 5.1; DAS28 Improvement \>0.6 * or Baseline DAS28 \>5.1; DAS28 Improvement \>1.2 * No response: Baseline DAS28 \>5.1 (high disease activity); DAS28 Improvement less than or equal to 1.2 or DAS28 Improvement less than or equal to 0.6
次要结局
- Number of Participants with Adverse Events(52 weeks)