NCT00144573已完成不适用
An Open-Label, Clinical Pharmacology Study to Evaluate the Safety and PK of MRA in Patients With RA With Renal Impairment
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
- 14
- 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 evaluate the safety and PK of MRA in patients with RA with Renal Impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 ACR (American College of Rheumatology) classification criteria
- •Patients with RA at least 6 months prior to enrollment
- •Patients with a creatinine clearance not less than 10 mL/min but no higher than 80 mL/min
排除标准
- •Patients with Class IV Steinbrocker functional impairment at enrollment
- •Patients who are undergoing dialysis
- •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 treatment with the investigational product
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 4)
研究者
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