跳至主要内容
临床试验/NCT01081717
NCT01081717已完成不适用

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

Janssen Biotech, Inc.0 个研究点目标入组 1,064 人开始时间: 2009年4月14日最近更新:
适应症
干预措施

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

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

研究者

申办方类型
Industry
责任方
Sponsor

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