NCT00882024已完成2 期
A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast With Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients With Active Rheumatoid Arthritis (RA)
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
- 250
- 主要终点
- Proportion of subjects who achieve of ACR20 response
研究概览
简要总结
The purpose of this study is to evaluate whether tranilast at two different dosages compared to placebo is effective in patients with active RA when added to continuing methotrexate (MTX) therapy.
详细描述
The primary objective of this study is to assess the efficacy and safety of two different doses of tranilast as determined by ACR20 response at 12 weeks.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving methotrexate
- •Have at least 8 painful/tender and 6 swollen joints
- •May be receiving oral steroids, chronic NSAIDs and/or hydroxychloroquine.
排除标准
- •Use of any anti-arthritic treatments except those allowed in inclusion criteria
- •Pregnant or nursing females
- •Abnormal laboratory values
- •History of clinically significant renal, hepatic dysfunction, psychiatric disorder, or alcohol/drug dependence
- •Clinically significant systemic infection
研究组 & 干预措施
1 Tranilast
Experimental
Tranilast, 300 mg/day
干预措施: Tranilast (Drug)
2 Tranilast
Experimental
Tranilast, 150 mg/day
干预措施: Tranilast (Drug)
3
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of subjects who achieve of ACR20 response
时间窗: Week 12
次要结局
- Proportion of subjects achieving ACR 50 and 70 response(Week 12)
- EULAR responders (e.g. DAS28 good or moderate responders)(week 12)
- Mean change from baseline of each ACR component(weeks 2, 4, 8, 12 and 16)
- Assess the safety and tolerability of both doses of tranilast(12 weeks)
研究者
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