NCT00233558终止4 期
Multicentre, Randomised, Open Label Study Comparing a "Scheduled Steroid Reduction Strategy" Versus a Free Steroid Reduction Strategy (Physician's Usual Practice for Reducing Steroids) in Patients With Active RA Treated With Humira 40 mg Eow + MTX During 9 Months
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Abbott
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Corticoid reduction and DAS 28
研究概览
简要总结
The purpose of the study is to evaluate the clinical efficacy of scheduled versus free reduction of steroid treatment in patients with active RA treated with adalimumab + MTX
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
- None
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
排除标准
- •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
结局指标
主要结局
Corticoid reduction and DAS 28
次要结局
- Patient reported outcomes
- Clinical response indicators
- Safety parameters
研究者
研究点 (2)
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