ISRCTN32398235终止2 期
A phase II, multicentre, randomised, double-blind, placebo-controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate disease modifying anti-rheumatic drug (DMARD) (SMP-114, 120 mg and 240 mg once daily) administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis
Dainippon Sumitomo Pharma Europe Ltd (UK)0 个研究点目标入组 300 人开始时间: 2006年2月23日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female patients aged at least 18, with rheumatoid arthritis (RA) for a minimum of six months
- •2. Has been receiving methotrexate treatment (stable for eight weeks)
- •3. Has active disease classified as American College of Rheumatology (ACR) functional class of I, II or III
排除标准
- •1. Has previously discontinued DMARD therapy due to hepatic intolerance
- •2. Has received any DMARD in addition to methotrexate during the four weeks prior to randomisation
- •3. Is receiving more than two DMARDs in addition to methotrexate at the time of screening
- •4. Is receiving or has received gold, leflunomide or biological agents including tumour necrosis factor (TNF) or Interleukin 1 (IL-1) inhibitors within the eight weeks prior to randomisation
- •5. Has previously failed two or more DMARDS
研究者
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