Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)-Cancer 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 second outpatient or inpatient diagnosis of any cancer (excluding NMSC and any carcinoma in situ diagnosis)
研究概览
简要总结
There are two main aims of this study.
First aim is to compare the risk of composite cancer outcomes, 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 common solid cancers (lung, colorectal, breast, prostate), hematological cancers, and non-melanoma skin cancer as separated 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 second outpatient or inpatient diagnosis of any cancer (excluding NMSC and any carcinoma in situ diagnosis)
时间窗: Through study time period (2012-2020)
次要结局
- Time to second outpatient or inpatient diagnosis of lymphatic/hematopoietic tissue cancers(Through study time period (2012-2020))
- Time to second outpatient or inpatient diagnosis of lymphoma(Through study time period (2012-2020))
- Time to second outpatient or inpatient diagnosis of breast cancer (excluding any carcinoma in situ diagnosis)(Through study time period (2012-2020))
- Time to second outpatient or inpatient diagnosis of prostate cancer (excluding any carcinoma in situ diagnosis)(Through study time period (2012-2020))
- Time to second outpatient or inpatient diagnosis of lung cancer (excluding any carcinoma in situ diagnosis)(Through study time period (2012-2020))
- Time to second outpatient or inpatient diagnosis of colorectal cancer (excluding any carcinoma in situ diagnosis)(Through study time period (2012-2020))
- Time to second outpatient or inpatient diagnosis of leukemia(Through study time period (2012-2020))
- Time to first procedure code occurring within 60 days of an outpatient or inpatient diagnosis of NMSC(Through study time period (2012-2020))
研究者
Seoyoung C. Kim
Associate Professor of Medicine
Brigham and Women's Hospital