NCT01136694已完成不适用
Economic Burden in Adult Patients Diagnosed With Rheumatoid Arthritis (RA) Receiving Treatment With Biologic Disease-modifying Antirheumatic Drugs (bDMARDs)
Bristol-Myers Squibb0 个研究点目标入组 695 人开始时间: 2009年5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
- 695
- 主要终点
- Patient-reported productivity loss using the Work Limitations Questionnaire (WLQ)
研究概览
简要总结
The purpose of this study is to explore the differences in productivity loss and costs between patients being treated for rheumatoid arthritis (RA) with biologic disease-modifying antirheumatic drugs (bDMARDs) compared to patients treated with conventional DMARDs.
详细描述
Time Perspective: Prospective with some retrospective analysis of claims data
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Evidence of a bDMARD or DMARD during the identification period (01 February 2009 - 31 July 2009)
- •18 years of age or older at the index year
- •At least 12 months of continuous enrollment in a large commercial US health plan affiliated with i3 Innovus, including the at least 6 months and up to 12 months prior the index date (i.e., the pre-index period) and at least 6 months following the index date (i.e., the post-index (follow-up) period)
- •Diagnosis of RA (reported on baseline survey)
排除标准
- •Diagnosis of psoriasis, plaque psoriasis, or psoriatic arthritis (ICD-9 code 696.0x, or 696.1x), ankylosing spondylitis (720.0x), Crohn's disease (555.x), non-Hodgkins lymphoma (200.xx, 202.0x-202.2x, 202.7x-202.8x), or ulcerative colitis (556.x) in any position at any time during the 18-month identification period
结局指标
主要结局
Patient-reported productivity loss using the Work Limitations Questionnaire (WLQ)
时间窗: At baseline (6-12 months after starting index bDMARD; variable for DMARD) and at 6 months (12-18 months after starting index bDMARD; variable for DMARD)
次要结局
- Direct and Indirect costs associated with lost productivity (as measured by WLQ)(At baseline (6-12 months after starting index bDMARD; variable for DMARD) and at 6 months (12-18 months after starting index bDMARD; variable for DMARD))
- Healthcare utilization and costs (total and RA-related)(At baseline (6-12 months after starting index bDMARD; variable for DMARD) and at 6 months (12-18 months after starting index bDMARD; variable for DMARD))
- Functionality (as measured by HAQ-DI)(At baseline (6-12 months after starting index bDMARD; variable for DMARD) and at 6 months (12-18 months after starting index bDMARD; variable for DMARD))
- RA severity (as measured by RAPID3)(At baseline (6-12 months after starting index bDMARD; variable for DMARD) and at 6 months (12-18 months after starting index bDMARD; variable for DMARD))
- Patient reported quality of life(At baseline (6-12 months after starting index bDMARD; variable for DMARD) and at 6 months (12-18 months after starting index bDMARD; variable for DMARD))
- Patient reported treatment satisfaction(At baseline (6-12 months after starting index bDMARD; variable for DMARD) and at 6 months (12-18 months after starting index bDMARD; variable for DMARD))
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