NCT01870908已完成不适用
Drug Use-result Survey to Assess the Safety and Efficacy of the Combination of Tacrolimus + Biological Agents in Daily Clinical Settings
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 664
- 主要终点
- Simplified disease activity index (SDAI)
研究概览
简要总结
This study is to evaluate the safety and the effectiveness of treatment with tacrolimus and biological agents.
详细描述
The purpose of this study is to confirm the safety of 24 weeks-treatment with the combination of tacrolimus + biological agents, and to assess the efficacy using SDAI, CDAI, DAS28-CRP, MMP-3, MHAQ in patients with rheumatoid arthritis who have not achieved SDAI remission despite of using biological agents for over 8 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with rheumatoid arthritis who have been treated with biological agents over 8 weeks but have not achieved SDAI remission (SDAI < 3.3)
排除标准
- 未提供
研究组 & 干预措施
tacrolimus + biological agents
干预措施: tacrolimus (Drug)
tacrolimus + biological agents
干预措施: biological agents (Drug)
结局指标
主要结局
Simplified disease activity index (SDAI)
时间窗: Baseline and week-24
次要结局
- Disease Activity Score 28 (DAS28)(Baseline, week-12 and week-24)
- Clinical disease activity index (CDAI)(Baseline, week-12 and week-24)
研究者
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