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
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
- 未提供
排除标准
- 未提供
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
相似试验
已完成
3 期
Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)Systemic Juvenile Idiopathic ArthritisNCT00144664Chugai Pharmaceutical19
已完成
1 期
A Study to Assess the Potential for Pre-systemic Inhibition of CYP3A by Idebenone Using Midazolam as a SubstrateDrug-Drug InteractionNCT02887443Santhera Pharmaceuticals32
已完成
3 期
Phase III Comparative Study(Open-Label) of MRA for Rheumatoid Arthritis(RA)Rheumatoid ArthritisNCT00144508Chugai Pharmaceutical306
已完成
3 期
PhaseⅢOpen-label Study of MRA for Rheumatoid Arthritis(RA)Rheumatoid ArthritisNCT00380601Chugai Pharmaceutical20
已完成
不适用
Drug-Drug Interaction Study of MRA in Patient With Rheumatoid Arthritis (RA)Rheumatoid ArthritisNCT00144560Chugai Pharmaceutical31