NCT00234845已完成3 期
A Multi-Centre Randomized, Double-Blind Study Comparing Adalimumab (D2E7) Plus Methotrexate With Placebo Plus Methotrexate on Work Disability in Subjects With Early Rheumatoid Arthritis
Abbott1 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2003年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Job loss measurement
研究概览
简要总结
The purpose of the study is to evaluate the effectiveness of adalimumab in combination with methotrexate compared to methotrexate alone on work disability in subjects with early 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
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
- •Subject is age 18 or older and in good health (Investigator discretion) with a recent stable medical history
- •Subject has a diagnosis of rheumatoid arthritis as defined by the 1987-revised ACR criteria
- •Subject must be in paid employment
- •Subject has self-reported work impairment since onset of symptoms
排除标准
- •A subject has chronic arthritis diagnosed before age 16 years.
- •Subject has been on preceding treatment with methotrexate Subject unable to withdraw from current DMARDs
- •Subject has preceding treatment with any biological TNF antagonist
- •Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
- •Female subject who is pregnant or breast-feeding or considering becoming pregnant
研究组 & 干预措施
未命名试验
干预措施: adalimumab (Drug)
未命名试验
干预措施: methotrexate (Drug)
结局指标
主要结局
Job loss measurement
次要结局
- Job productivity measurements
- DAS28
- Patient reported outcomes
- Safety parameters
研究者
研究点 (1)
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