Usefulness of Non TNF Usage in Rheumatoid Arthritis Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change from Baseline Values of DAS28-CRP
研究概览
简要总结
The aim of this study is to examine the efficacy and adverse events in the following 3 groups in rheumatoid arthritis patients:
- Sarilumab treatment for 12 months
- Tocilizmab treatment for 12 months
- Abatacept treatment for 12 months
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •・ RA patients
排除标准
- •Not RA patients
- •RA patients who are allergic to the drugs, refused to do this research, or who are pregnant
研究组 & 干预措施
SAR, usually subucutaneous injection every 2 weeks
干预措施: Drug: "Salirumab" (Drug)
SAR, usually subucutaneous injection every 2 weeks
干预措施: Drug: "Tocilizmab" (Drug)
TCZ, usually subucutaneous injection every 2 weeks
干预措施: Drug: "Salirumab" (Drug)
TCZ, usually subucutaneous injection every 2 weeks
干预措施: Drug: "Tocilizmab" (Drug)
ABT, usually subucutaneous injection every week
干预措施: Drug: "Salirumab" (Drug)
ABT, usually subucutaneous injection every week
干预措施: Drug: "Tocilizmab" (Drug)
ABT, usually subucutaneous injection every week
干预措施: Drug: "Abatacept" (Drug)
SAR, usually subucutaneous injection every 2 weeks
干预措施: Drug: "Abatacept" (Drug)
TCZ, usually subucutaneous injection every 2 weeks
干预措施: Drug: "Abatacept" (Drug)
结局指标
主要结局
Change from Baseline Values of DAS28-CRP
时间窗: Baseline and 1 year
Assessment of efficacy in rheumatoid arthritis patients for 1 year treated by salirumab (N=30), tocilizumab (N=30), or abatacept (N=30).
Assessment of adverse event in rheumatoid arthritis patients for 1 year treated by salirumab (N=30), tocilizumab (N=30), or abatacept (N=30).
时间窗: at 1 year
次要结局
未报告次要终点
研究者
Yukio Nakamura
Principle Investigator
Shinshu University