NCT02616328终止不适用
A Multicenter, Prospective, Observational, Non-Interventional Study Evaluating the Efficacy and Safety of Using Tocilizumab (TCZ) for Confirmed Rheumatoid Arthritis (RA) Patients In Clinical Practice
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Number of Participants with Adverse Events
研究概览
简要总结
This is a single-arm, open-label, non-randomized, multicenter trial to evaluate the efficacy and safety of using tocilizumab for confirmed rheumatoid arthritis participants in clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with moderate-to-severe active rheumatoid arthritis (RA) for over 3 months
- •Started on tocilizumab, with or without previous history of biological treatment
排除标准
- •Pregnant or lactating women
- •Treated with an investigational drug within 30 days prior to initiation of study drug
- •Having a condition that, in the opinion of the investigator, could compromise the participant's safety or interfere with the study results
结局指标
主要结局
Number of Participants with Adverse Events
时间窗: Up to 30 months
Percentage of Participants with a 28-Joint Disease Activity Score (DAS28) < 2.6 at Week 24
时间窗: Week 24
次要结局
- Percentage of Participants with Participant Global Health (PGH) < or = 1/10 at Week 12 and Week 24(Week 12 and Week 24)
- Percentage of Participants with Clinical Disease Activity Index (CDAI) < or = 2.8 at Week 12 and Week 24(Week 12 and Week 24)
- Percentage of Participants with DAS28 < or = 3.2 at Week 12 and Week 24(Week 12 and Week 24)
- Percentage of Participants with CDAI < or = 10 at Week 12 and Week 24(Week 12 and Week 24)
- Percentage of Participants with DAS28 < 2.6 at Week 12(Week 12)
- Mean Change in DAS28(Baseline, Week 12, and Week 24)
- Mean Change in CDAI(Baseline, Week 12, and Week 24)
- Percentage of Participants with Tender Joint Count-28 Joints (TJC28) < or = 1 at Week 12 and Week 24(Week 12 and Week 24)
- Percentage of Participants with Swollen Joint Count-28 Joints (SJC28) < or = 1 at Week 12 and Week 24(Week 12 and Week 24)
- Percentage of Participants with C-Reactive Protein (CRP) < or = 1mg/dL at Week 12 and Week 24(Week 12 and Week 24)
- Mean Change in TJC(Baseline and Week 24)
- Mean Change in SJC(Baseline and Week 24)
- Mean Change in CRP(Baseline and Week 24)
- Mean Change in PGH(Baseline and Week 24)
研究者
研究点 (2)
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