Risk of Cardiovascular Events in Patients Using Tocilizumab as Compared With Other Biologics in Multiple Large Healthcare Databases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48,950
- 主要终点
- Time to First Event of Myocardial Infarction (MI) or Stroke with Tocilizumab Versus Tumor Necrosis Factor Inhibitor (TNFi) Therapies
研究概览
简要总结
This retrospective cohort study will analyze data from multiple large U.S. health insurance claims databases to compare use of tocilizumab to other biologic disease-modifying anti-rheumatic drugs (DMARDs) in real world patients with RA. Using the date of dispensing as the index date, the analysis will compute the time to first event for several cardiovascular outcomes.
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
- •At least 1 inpatient or 2 outpatient diagnoses of RA
- •Continuous medical/pharmacy coverage and full claims data available
- •At least 6 months of insurance plan enrollment prior to index date
排除标准
- •Nursing home residents
- •Human immunodeficiency virus (HIV)
- •Malignancy
- •Receipt of chemotherapy
- •End-stage renal disease, dialysis, or transplant
- •Use of rituximab
- •Recent cardiovascular event (includes MI, stroke, ACS, or HF) within 90 days prior to index date
研究组 & 干预措施
Non-TNFi Biologics
Real world patients with RA with a dispensing history for non-TNFi biologics (such as abatacept or tofacitinib) will be included.
干预措施: Other Biologics (Drug)
TNFi Biologics
Real world patients with RA with a dispensing history for TNFi biologics will be included.
干预措施: Other Biologics (Drug)
Tocilizumab
Real world patients with RA with a dispensing history for tocilizumab will be included.
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Time to First Event of Myocardial Infarction (MI) or Stroke with Tocilizumab Versus Tumor Necrosis Factor Inhibitor (TNFi) Therapies
时间窗: Up to approximately 1 year from index date
次要结局
- Time to First Event of MI or Stroke with Tocilizumab Versus Non-TNFi Therapies(Up to approximately 1 year from index date)
- Time to Hospitalization for Coronary Revascularization Procedure(Up to approximately 1 year from index date)
- Time to Hospitalization for Acute Coronary Syndrome (ACS)(Up to approximately 1 year from index date)
- Time to First Event of MI, Stroke, Coronary Revascularization Procedure, or ACS(Up to approximately 1 year from index date)
- Time to Heart Failure (HF) Requiring Hospitalization(Up to approximately 1 year from index date)
- Time to All-Cause Death(Up to approximately 1 year from index date)