Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)- Cardiovascular Endpoints
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105,711
- 试验地点
- 1
- 主要终点
- Time to first composite cardiovascular endpoint consisting of myocardial infarction or stroke
研究概览
简要总结
There are two main aims of this study.
First aim is to compare the risk of cardiovascular events (including myocardial infarction or stroke), between patients treated with tofacitinib and patients treated with TNF inhibitors (TNFi) for rheumatoid arthritis (RA) among, 1) "real world evidence (RWE)" cohorts including routine care patient population from the US and, 2) "Randomized controlled trial (RCT) DUPLICATE" cohorts including routine care patient population who meet inclusion and exclusion criteria of the Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis ("ORAL Surveillance", NCT02092467) clinical trial.
Second aim is to examine the risk of myocardial infarction, stroke, heart failure hospitalization, coronary revascularization, and all-cause mortality as separate endpoints when comparing tofacitinib with TNFi in patients with RA among, 1) "real world evidence (RWE)" cohort including routine care patient population from the US and, 2) "Randomized controlled trial (RCT) DUPLICATE" cohort including routine care patient population who meet inclusion and exclusion criteria of the Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis ("ORAL Surveillance", NCT02092467) clinical trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Patients treated with Tofacitinib
Real-World Evidence (RWE) and RCT-Duplicate
干预措施: Tofacitinib (Drug)
Patients treated with TNF inhibitors
Real-World Evidence (RWE) and RCT-Duplicate
干预措施: TNF Inhibitor (Drug)
结局指标
主要结局
Time to first composite cardiovascular endpoint consisting of myocardial infarction or stroke
时间窗: Through study time period (2012-2020)
Myocardial infarction OR Stroke
次要结局
- Time to stroke(Through study time period (2012-2020))
- Time to myocardial infarction(Through study time period (2012-2020))
- Time to coronary revascularization(Through study time period (2012-2020))
- Time to all-cause mortality(Through study time period (2012-2020))
- Time to heart failure hospitalization(Through study time period (2012-2020))
研究者
Rishi J. Desai
Assistant Professor of Medicine
Brigham and Women's Hospital