NCT00316771已完成2 期
A Randomized, Double-blind, Placebo-controlled, Study to Determine the Efficacy and Safety of 5 Dose Regimens of RO4402257 in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy.
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 374
- 主要终点
- Percentage of patients with ACR 20 response
研究概览
简要总结
This 6 arm study will evaluate the efficacy and safety of different doses of P38 Inhibitor (4) in patients with RA currently having an inadequate clinical response to methotrexate. Patients will be randomized to receive P38 Inhibitor (4) (50,150 or 300 qd po,and 25 or 75 bid po) or placebo, and will remain on the stable dose of methotrexate. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.
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
- •adult patients >=18 years of age;
- •active rheumatoid arthritis;
- •current inadequate clinical response to methotrexate.
排除标准
- •receiving any other disease-modifying anti-rheumatic drug, with the exception of hydroxychloroquine or chloroquine.
研究组 & 干预措施
P38 Inhibitor (4) 150mg
Experimental
干预措施: P38 Inhibitor (4) 150mg (Drug)
P38 Inhibitor (4) 25mg
Experimental
干预措施: P38 Inhibitor (4) 25mg (Drug)
P38 Inhibitor (4) 300mg
Experimental
干预措施: P38 Inhibitor (4) 300mg (Drug)
P38 Inhibitor (4) 50mg
Experimental
干预措施: P38 Inhibitor (4) 50mg (Drug)
P38 Inhibitor (4) 75mg
Experimental
干预措施: P38 Inhibitor (4) 75mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of patients with ACR 20 response
时间窗: Week 12
次要结局
- Change in ACR core set, DAS 28, HAQ disability index, SF-36, withdrawals, AEs, lab parameters.(Throughout study)
- Percentage of patients with ACR 50/70 response(Week 12)
研究者
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