NCT00303563已完成2 期
A Randomized, Double-blind Study to Compare the Effect of RO4402257 Monotherapy and Methotrexate Monotherapy on Disease Response in Patients With Active Rheumatoid Arthritis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 204
- 主要终点
- Percentage of patients with ACR 20 response
研究概览
简要总结
This 4 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of P38 Inhibitor (4) (50, 150 or 300mg po qd) monotherapy versus methotrexate monotherapy in adult patients with active rheumatoid arthritis. Patients will be randomized to receive one of 3 doses of P38 Inhibitor (4) or 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, with active RA;
- •receiving treatment for RA on an outpatient basis;
- •females of child-bearing potential, or nonsterilized males with partners of child-bearing potential, must use reliable contraception during, and for 4 weeks after, the study.
排除标准
- •major surgery within 8 weeks prior to screening;
- •rheumatic autoimmune disease or inflammatory joint disease other than RA;
- •treatment with methotrexate within 8 weeks of baseline;
- •concurrent use of DMARDs, including anti-TNF or other biologic therapy for RA.
研究组 & 干预措施
1
Experimental
干预措施: P38 Inhibitor (4) (Drug)
2
Experimental
干预措施: P38 Inhibitor (4) (Drug)
3
Experimental
干预措施: P38 Inhibitor (4) (Drug)
4
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
- Percentage of patients with ACR 50/70 response.(Week 12)
- Change in ACR core set, DAS 28, FACIT-F fatigue assessment, AEs, laboratory parameters.(Throughout study)
研究者
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