NCT00144560已完成不适用
An Open-Label, Clinical Pharmacology Study to Investigate Drug-Drug Interaction in Patients With RA
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 主要终点
- 20% improvement based on the ACR criteria compared with the baseline value.
研究概览
简要总结
This is an open-label, clinical pharmacology study to investigate drug-drug interaction in patients with RA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are diagnosed with RA according to the 1987 American College of Rheumatology (ACR) classification criteria
- •Patients who contracted RA at least 6 months prior
排除标准
- •Patients with Class IV Steinbrocker functional impairment at enrollment.
- •Patients who have been treated for the underlying disease with a biological agent, such as infliximab or etanercept and have been receiving treatment with leflunomide, within 12 weeks before initiation of treatment with the probe drug
研究组 & 干预措施
未命名试验
干预措施: MRA(Tocilizumab) (Drug)
结局指标
主要结局
20% improvement based on the ACR criteria compared with the baseline value.
时间窗: throughout study
次要结局
- Time courses taken from baseline values for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable.(Week 0,Week 1, Week 2)
研究者
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