NCT02346942已完成不适用
Factors Associated With Biologic Disease Modifying Antirheumatic Drugs Switching and Impact of Healthcare Resource Utilization in a Managed Care Setting
Bristol-Myers Squibb0 个研究点目标入组 4,099 人开始时间: 2006年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,099
- 主要终点
- Measure the change in population of patients who are treated with first- or second-line bDMARD therapy (with or without Methotrexate) to another bDMARD therapy
研究概览
简要总结
The Primary objective of this study is to understand the rheumatoid arthritis (RA) population in national integrated delivery network who are treated with first- or second-line biologic disease modifying anti-rheumatic drug (bDMARD) therapy (with or without Methotrexate) and to evaluate switching patterns and reasons for switching to another bDMARD.
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
- •Diagnosis of RA (ICD-9 714.xx) anytime during the study time period of 1/1/2007 to 10/31/2012
- •Patients ≥18 years of age at diagnosis date
- •Required to have to have 6 months pre-index and 12 months post-index continuous membership and drug benefit eligibility in the database
排除标准
- •Patients less than 18 years of age on diagnosis date
- •If they had a diagnosis of Crohn's disease, psoriasis, psoriatic arthritis, ulcerative colitis, ankylosing spondylitis, regional enteritis, or anal fistula during the pre-index period
- •Patients who had <7 days supply of adalimumab or etanercept
- •Patients currently in a clinical trial during our study
- •If patients are in the second-line cohort and have more than 1 prior bDMARD
结局指标
主要结局
Measure the change in population of patients who are treated with first- or second-line bDMARD therapy (with or without Methotrexate) to another bDMARD therapy
时间窗: Approximately 6 months
Measure the reasons for switching to another bDMARD based on Provider documentation in chart notes
时间窗: 6 months pre-index date
次要结局
- Evaluate RA related and all cause healthcare resource utilization of doctor visits, hospitalizations and ER visits as patients switch bDMARDs measured from Patient heath claims data from KPSC integrated healthcare data(6 month pre-index and 6 months pre-index date and 12 month post index follow up)
研究者
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