EUCTR2010-021020-94-IT进行中（未招募）不适用
A randomized, double-blind, parallel-group, placebo- and active calibrator-controlled study assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-alpha) antagonists. - ND
Sanofi-aventis Recherche & D?veloppement0 个研究点目标入组 250 人开始时间: 2010年9月28日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Diagnosis of rheumatoid arthritis = 6 months duration and American College of Rheumatology (ACR) Class I-III functional status at screening and baseline visits Active disease, defined as: - At least 6 of 68 tender joints and 6 of 66 swollen joints at screening and baseline visits - hs-C-Reactive Protein (hs-CRP) >10 g/L or Erythrocyte Sedimentation Rate (ESR) >28 mm/hr at screening visit Continuous treatment with Methotrexate for at least 12 weeks and on stable dose (minimum 10 mg/week) for at least 6 weeks prior to the screening visit Patient considered as Primary TNF-a blocker nonresponder. i.e.: - Appropriate for previous TNF-a blocker therapy - Lack of adequate clinical response after at least 3 months TNF-a blocker therapy (up to 2 agents) with Methotrexate or other synthetic disease modifiying anti-rheumatic drug (DMARD) co-therapy
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Age <18 years or >75 years Pregnant or breastfeeding women or women of childbearing potential, unwilling to utilize adequate contraception or not to become pregnant during the entire study. Unexplained fever (>38?C), or chronic, persistent, or recurring infection(s) History of demyelinating disease Current underlying hepatobiliary disease
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