NCT00661284已完成不适用
A Study to Investigate the Duration of Maintained Efficacy in Patients With Rheumatoid Arthritis Who Had Treated With MRA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 5
- 主要终点
- Proportion of patients who maintained efficacy during 52-weeks after the last infusion of MRA in the previous studies.
研究概览
简要总结
A 52-week follow up study to investigate the duration of maintenance of efficacy in patients with RA and achieved low disease activity in clinical trials of MRA and stopped the treatment
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who achieved DAS28 of < 3.2 at the last observation and at least one time point among the two previous assessment time points in a previous studies.
排除标准
- •Patients who receive DMARDs or immunosuppressants between the last observation in a previous studies and the first observation in this study
结局指标
主要结局
Proportion of patients who maintained efficacy during 52-weeks after the last infusion of MRA in the previous studies.
时间窗: every 4th week up to the 48th week
Relationship between serum IL-6 concentration at the last observation of the previous studies and the duration of maintenance of efficacy
时间窗: throughout study
次要结局
- Efficacy: Proportion of patients who maintained efficacy among patients whose DAS28 was <2.6 at the last observation of the previous studies.(throughout study)
- Efficacy: Time course of DAS28 during the treatment-free period in the present study(throughout study)
- Efficacy: Relationship between serum IL-6 concentration at the last observation of the previous studies and the time course of DAS28 during the treatment-free period in the present study.(throughout study)
研究者
研究点 (5)
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