NCT03755466招募中2 期
Efficacy and Safety of Baricitinib in Rheumatoid Arthritis Patients Compared With Those Treated by Biologics or Tofacitinib
适应症
干预措施
相关药物
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
- Assessment of Disease Activity in rheumatoid patients for 1 year treated by baricitinib (N=30), biologics (N=30), or tofacitinib (N=30). Also, the efficacy and adverse event of each drug for 1 year in the RA patients.
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:
- Baricitinib treatment for 12 months
- Biologics treatment for 12 months
- Tofacitinib treatment for 12 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（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
Tofa
Active Comparator
干预措施: "Biologics" (Drug)
BARI
Active Comparator
干预措施: "Biologics" (Drug)
Bio
Active Comparator
干预措施: "Baricitinib", "olumiant®" (Drug)
Bio
Active Comparator
干预措施: Tofacitinib 5 MG [Xeljanz] (Drug)
Tofa
Active Comparator
干预措施: "Baricitinib", "olumiant®" (Drug)
BARI
Active Comparator
干预措施: Tofacitinib 5 MG [Xeljanz] (Drug)
结局指标
主要结局
Assessment of Disease Activity in rheumatoid patients for 1 year treated by baricitinib (N=30), biologics (N=30), or tofacitinib (N=30). Also, the efficacy and adverse event of each drug for 1 year in the RA patients.
时间窗: Change from Baseline Values of DAS28-CRP at 1 year in each group
次要结局
未报告次要终点
研究者
Yukio Nakamura
Lecturer at Shinshu University School of Medicine
Shinshu University
研究点 (1)
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