NCT00095342已完成2 期
A Double-Blind, Placebo-Controlled, Parallel, Randomized Study to Evaluate the Efficacy and Safety of 3 Oral Dose Levels of TMI-005 in Subjects With Active Rheumatoid Arthritis on a Background of Methotrexate
Wyeth is now a wholly owned subsidiary of Pfizer8 个研究点 分布在 2 个国家目标入组 390 人开始时间: 2004年11月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 390
- 试验地点
- 8
研究概览
简要总结
The primary objective of this clinical research study is to compare the efficacy and the safety of 3 dose levels of oral TMI-005 in comparison with placebo in subjects with active Rheumatoid Arthritis (RA) who have been receiving stable doses of Methotrexate (MTX).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet American College of Rheumatology (ACR) criteria for RA
- •Have active RA
- •Disease duration of at least 6 months
- •Disease onset at > 16 years of age.
排除标准
- •Any prior use of anti-TNF alpha biologics, rituximab, receipt of anti-CD4 or diphtheria interleukin-2 fusion protein or other immunosuppressive biologics (except for anakinra)
- •Largely or wholly incapacitated with the subject bedridden or confined to a wheelchair, permitting limited or no self-care
- •Pregnant or breastfeeding women or women planning to become pregnant during the study or within 12 weeks after the last dose of test article
研究者
研究点 (8)
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