NCT00256919已完成2 期
A Randomised, Placebo-controlled, Parallel Group Single Dose Study of GW856553 in Patients With Active RA to Investigate the C-Reactive Protein (CRP) Dose Response Relationship
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 18
- 主要终点
- C-reactive protein (CRP) levels 72 hours post-dose.
研究概览
简要总结
This study is designed to compare a range of doses of GW856553 versus placebo on the biomarkers associated with rheumatoid arthritis
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have a diagnosis of RA according to the revised 1987 criteria of the American College of Rheumatology.
- •Must have 3 or more swollen or 3 or more tender/painful joints at screening.
- •Must be on stable weekly methotrexate (2.5mg-25mg) for at least eight weeks prior to screening.
排除标准
- •Must not be morbidly obese.
结局指标
主要结局
C-reactive protein (CRP) levels 72 hours post-dose.
时间窗: 72 hours post-dose.
次要结局
- C-reactive protein (CRP) levels 24 and 48 hours post-dose(24 and 48 hours post-dose)
研究者
研究点 (18)
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