NCT00319917已完成4 期
FK506 Phase 4 Study: A Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA Patients
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 123
- 主要终点
- Radiographic progression of structural joint damage
研究概览
简要总结
The purpose of the study is to assess the efficacy on joint damage and safety in RA patients treated with DMARDs in a double blind, placebo controlled study.
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
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed as rheumatoid arthritis by the revised ACR criteria
- •Those who have been treated with an adequate stable dose of either methotrexate, salazosulfapyridine or bucillamine
- •Those who have at least one erosion on X-ray of hands, wrists or feet
排除标准
- •Those who have been treated with any biologic drugs or leflunomide
- •Those who meet Class 4 with the Steinbrocker functional classification
研究组 & 干预措施
1
Experimental
干预措施: tacrolimus (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Radiographic progression of structural joint damage
时间窗: 52 Weeks
次要结局
- Signs and symptoms of rheumatoid arthritis(52 Weeks)
研究者
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