NCT00716248Unknown4 期
The Bucillamine Study of Holding Remission After Infliximab Dose-off in Patients With Rheumatoid Arthritis Receiving Methotrexate
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The rate of disease flare
研究概览
简要总结
Patients with rheumatoid arthritis who have been well controlled with methotrexate plus infliximab may remain in remission or low disease activity without infliximab. And the chance of sustained remission increase by the addition of another DMARD, bucillamine, at the time of discontinuing infliximab. The BuSHIDO trial is the prospective, randomized, controlled study comparing MTX monotherapy and MTX plus bucillamine combination therapy as to the rate of disease flare after discontinuing infliximab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RA according to American College of Radiology (ACR) classification criteria
- •Age of 20 or greater
- •DAS28-ESR < 3.2 or DAS28-CRP < 2.6 for more than 6 months
排除标准
- •Previously teated with bucillamine
- •Pregnancy or lactation
研究组 & 干预措施
1
Experimental
干预措施: bucillamine (Drug)
1
Experimental
干预措施: methotrexate (Drug)
2
Active Comparator
干预措施: methotrexate (Drug)
结局指标
主要结局
The rate of disease flare
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (1)
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