NCT00647491已完成2 期
A Study of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 352
- 试验地点
- 25
- 主要终点
- ACR20
研究概览
简要总结
The primary objective of this study is to evaluate the safety, efficacy and pharmacokinetics of three doses of adalimumab in adult Japanese subjects with RA
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet ACR criteria for diagnosis of active RA and have at both screening and baseline visits >10 swollen joints, >12 tender joints.
- •Subjects must have failed prior treatment with one or more DMARDs.
- •A negative (serum) pregnancy test for all female subjects of child-bearing potential at screening and a negative (urine) pregnancy test prior to study drug administration.
- •Body weight less than or equal to 100 kg
排除标准
- •A history of, or current, acute inflammatory joint disease of different origin from RA.
- •Prior treatment with any TNF antagonist, including adalimumab.
- •Any ongoing chronic or active infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics.
- •Unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke or any poorly controlled medical condition.
结局指标
主要结局
ACR20
时间窗: Week 24
次要结局
- ACR20(Week12)
- ACR50(Weeks 12 and 24)
- ACR70(Weeks 12 and 24)
研究者
研究点 (25)
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