Comparison of Dosing and Costs Between Rheumatoid Arthritis Patients Treated With Remicade® Versus Orencia®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5,451
- 主要终点
- Escalation in dosing amount or frequency
研究概览
简要总结
The purpose of this study is to describe infliximab and abatacept dosing patterns (i.e., dosing amount and frequency) and costs among a population of managed care enrollees with RA. This study will also identify changes in infliximab and abatacept dosing over time and the implication these changes may have on the costs of medication administration.
详细描述
This study will be conducted in two parts. The primary analysis is a longitudinal analysis, where patients' health care claims from a period during which the patient was continuously enrolled in the health plan will be used to evaluate the primary outcome (i.e., dose escalation). The second analysis will be cross-sectional, where patients' health care claims from a fixed period of time (i.e., 2008) will be used to examine health care cost.
The final enrollment for the longitudinal portion of the study was 2,001 (1,306 infliximab and 695 abatacept patients). Final enrollment for the cross-sectional portion was 3,450 (2,646 infliximab and 806 abatacept patients). There may be some overlap in these numbers.
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
- •Commercial health plan enrollees with medical and pharmacy coverage
- •At least 3 claims on separate days for infliximab (HCPCS J1745) or abatacept (HCPCS C9230, J0129, J3590) administration during the subject identification period
- •The 3 initial claims for abatacept occurred within a 6-week period inclusive of the index date and the three initial claims for infliximab occur within a 9-week period inclusive of the index date
- •Presence of a diagnosis of RA (ICD-9-CM 714.xx)
- •Continuous enrollment during the baseline and follow-up periods
- •At least 18 years of age or older on the index date
排除标准
- •Prior exposure to the index medication during the baseline period
- •Diagnosis of psoriasis (ICD-9-CM 696.1), psoriatic arthritis (696.0), ankylosing spondylitis (720.0), Crohn's disease (555.x), or ulcerative colitis (556.x) in any position at any time during the study period
- •Exposure to alefacept (HCPCS J0215, C9211, C9212) or efalizumab (HCPCS S0162) at any time during the study period
结局指标
主要结局
Escalation in dosing amount or frequency
时间窗: Throughout follow-up period (variable, between 6 weeks and 39 months)
次要结局
- Switch/discontinuation of index therapy(Throughout follow-up period (variable, between 6 weeks and 39 months))
- Number of infusions(Throughout follow-up period (variable, between 6 weeks and 39 months))
- Average dose per infusion(Throughout follow-up period (variable, between 6 weeks and 39 months))
- Frequency of infusions(Throughout follow-up period (variable, between 6 weeks and 39 months))
- Average costs per infusion(Throughout follow-up period (variable, between 6 weeks and 39 months))
- Health care resource utilization(Throughout follow-up period (variable, between 6 weeks and 39 months))
- Health care costs(Throughout follow-up period (variable, between 6 weeks and 39 months))
- Concurrent medication use(Throughout follow-up period (variable, between 6 weeks and 39 months))
- Time to maximum dose(Throughout follow-up period (variable, between 6 weeks and 39 months))
- Time to dose escalation(Throughout follow-up period (variable, between 6 weeks and 39 months))