NCT01166620已完成不适用
Observational Real-world Evaluation of Cost of Infections of RA Patients on Biologics
Bristol-Myers Squibb0 个研究点目标入组 4,000 人开始时间: 2010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
- 4,000
- 主要终点
- Incremental total and component (inpatient, outpatient and pharmacy) direct costs due to infection in patients treated with etanercept, adalimumab or infliximab versus abatacept
研究概览
简要总结
To quantify the incremental cost of infections in patients treated with etanercept, adalimumab or infliximab versus abatacept.
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
- •18 years of age and older;
- •Have a diagnosis of of rheumatoid arthritis (ICD-9:714x.xx);
- •Have been enrolled for at least 6 months for the 6 months assessment and 12 months for the 12 months assessment;
- •are enrolled in a health plan between February 2006 and June 2009
- •have claims indicating at least one use of either abatacept, etanercept, adalimumab or infliximab for at least 6 months for teh 6 months assessment and 12 months for the 12 months assessment
排除标准
- •Patients not continuously eligible for health plan benefits for the same evaluation periods will be excluded
- •Patients who are on other biologics in the 6 and 12 month post-index period will be excluded (ex. those in the abatacept cohort will be excluded if they also have claims for etanercept in the 6 and 12 month post-index period).
- •Patients on biologics 6 months prior to the biologic index date will also be excluded
- •Patients with diagnosis for other non-RA conditions commonly treated with biologics (ex. Crohn's disease) during the 6 month pre-index period.
结局指标
主要结局
Incremental total and component (inpatient, outpatient and pharmacy) direct costs due to infection in patients treated with etanercept, adalimumab or infliximab versus abatacept
时间窗: 6 months
Incremental total and component (inpatient, outpatient and pharmacy) direct costs due to infection in patients treated with etanercept, adalimumab or infliximab versus abatacept.
时间窗: 1 year
次要结局
未报告次要终点
研究者
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