A Large US Health Insurance Claims Database Will be Used to Estimate the Incidence of Serious Outcomes in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis Treated With Golimumab and Other Types of Biological and Systemic Non Biological Treatments
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,064
- 主要终点
- Estimate incidence of serious infections, malignancies, and other selected outcomes in patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis initiating golimumab and other biological and systemic non-biological treatment
研究概览
简要总结
The participants included in this observational study will be drawn from a research database containing claims and enrollment data for members of a large, geographically diverse US health plan.The objective of this study is to estimate the rate of serious infections, tuberculosis, malignancies, and other outcomes in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis patients treated with golimumab, anti-tumor necrosis factor (TNF) biologics, non-anti-TNF biologics, or systemic non-biological treatments.
详细描述
The participants included in this study will be drawn from the Ingenix Normative Health Informatics Database, a proprietary research database containing claims and enrollment data dating back to 1993 for members of a large, geographically diverse US health plan. This study will include cohorts of participants who have claims consistent with a diagnosis of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis and who initiate golimumab, anti-TNF biologics, non-anti-TNF biologics, or systemic non-biological treatments. Participants will be identified by claims bearing codes for dispensed drugs, procedures or diagnoses and followed after the launch of golimumab for up to 8 years. A sample of enrolled health plan members without claims evidence of diagnosis or treatment of Rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis will also be selected. The claims database will be used to estimate the incidence of the primary outcomes of serious infections, tuberculosis (TB) and non-TB mycobacterial infections, malignancies such as lymphoma, and other selected outcomes. No study agents will be administered in this study. All participants will receive standard-of-care treatment as prescribed by their physician
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
- 0 Years 至 99 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Complete medical coverage and pharmacy benefits
- •Six months of continuous enrollment prior to the date of cohort entry
排除标准
- •Participants will be excluded if they do not have information on age, gender or enrollment
研究组 & 干预措施
001
golimumab as prescribed
干预措施: golimumab (Biological)
002
anti-TNF biologics as prescribed
干预措施: anti-TNF biologics (Biological)
003
non-anti-TNF biologics as prescribed
干预措施: non-anti-TNF biologics (Biological)
004
systemic non-biological treatments as prescribed
干预措施: systemic non-biological treatments (Drug)
005
general population non-treated cohort
干预措施: general population (Other)
结局指标
主要结局
Estimate incidence of serious infections, malignancies, and other selected outcomes in patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis initiating golimumab and other biological and systemic non-biological treatment
时间窗: The study will be approximately 8 years in duration
次要结局
未报告次要终点
