NCT00076206终止2 期
A Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate the Efficacy and Safety of 3 Different Oral Dose Levels (1, 2, And 4 Mg) of CCI-779 in Subjects With Active Rheumatoid Arthritis on Concomitant Methotrexate Therapy
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点开始时间: 2003年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
研究概览
简要总结
The primary objective of this study is to compare the therapeutic response and safety of 3 oral dose levels of CCI-779, with placebo in subjects with active rheumatoid arthritis (RA) who have been receiving stable doses of methotrexate (MTX) for at least 8 weeks.
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 consisting of ≥ 6 swollen and ≥ 6 painful joints
- •ACR functional class I-III
- •Exclusion Criteria
- •At screening the subject's prior medications are reviewed. (Prior history of disease-modifying antirheumatic drug (DMARD) use is recorded, including the start and stop dates of the most recently taken DMARDs)
- •Significant concurrent medical diseases
- •Abnormal chest radiograph, including findings consistent with interstitial pneumonitis, granulomatous disease, or pleural effusion and/or infiltration
排除标准
- 未提供
研究组 & 干预措施
A
Experimental
CCI-779 1 mg dose to be taken orally daily up to 12 weeks.
干预措施: CCI-779 (Drug)
B
Experimental
CCI-779 2 mg dose to be taken orally daily up to 12 weeks.
干预措施: CCI-779 (Drug)
C
Experimental
CCI-779 4 mg dose to be taken orally daily up to 12 weeks.
干预措施: CCI-779 (Drug)
D
Placebo Comparator
Placebo dose to be taken orally daily up to 12 weeks.
干预措施: Placebo (Drug)
研究者
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