NCT01277328终止不适用
Tocilizumab (RoActemra) poST Marketing Observational Study in DMARD-IR Patients to Assess Efficacy and Safety in routiNE Clinical Practice - STONE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 95
- 主要终点
- Mean change in Disease Activity Score 28 (DAS28)
研究概览
简要总结
This observational, prospective, open-label, multi-center study will evaluate the effectiveness in disease reduction and the safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected for 11 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients >/=18 years of age
- •Patients with rheumatoid arthritis eligible for RoActemra
排除标准
- •Hypersensitivity to RoActemra
- •Active, severe infections
结局指标
主要结局
Mean change in Disease Activity Score 28 (DAS28)
时间窗: 11 months
次要结局
- Incidence of adverse events(11 months)
- Proportion of patients with a change in Disease Activity Score 28 (DAS28)(5 months)
- European League Against Rheumatism (EULAR) response rates(20 weeks)
- Proportion of patients with disease remission(20 weeks)
- Proportion of patients with low disease activity(20 weeks)
研究者
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