NCT02414633已完成不适用
Special Investigation (Working Productivity and Activity Impairment in Japanese Patients With Psoriatic Arthritis)
AbbVie0 个研究点目标入组 148 人开始时间: 2015年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 主要终点
- Work Productivity and Activity Impairment Psoriatic Arthritis Questionnaire (WPAI:PsA) Percentage of Overall Work Impairment (OWI): Change From Baseline to Week 24
研究概览
简要总结
A special investigation (post marketing observational study [PMOS]/non-mandatory) of HUMIRA® in Japanese psoriatic arthritis patients who are engaged in paid work.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paid workers (including part-time) with Psoriatic Arthritis, who have never administered adalimumab, and are diagnosed by ClASsification of Psoriatic ARthritis (CASPAR) criteria
排除标准
- •Subjects showing decreased basic activities of daily life such as hospitalization and bedridden
- •Subjects with contraindications to adalimumab
结局指标
主要结局
Work Productivity and Activity Impairment Psoriatic Arthritis Questionnaire (WPAI:PsA) Percentage of Overall Work Impairment (OWI): Change From Baseline to Week 24
时间窗: Baseline (Week 0), Week 24
WPAI:PsA is a questionnaire used to evaluate lost productivity due to PsA; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Percentage of overall work impairment due to PsA (OWI) is calculated as: Absenteeism + (1 - Absenteeism) \* Presenteeism. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.
次要结局
- WPAI:PsA Absenteeism: Change From Baseline to Weeks 4, 12, 16 and 24(Baseline (Week 0), Week 4, Week 12, Week 16, and 24)
- Psoriatic Arthritis Screening and Evaluation Questionnaire (PASE): Change From Baseline to Weeks 4, 12, 16 and 24(Baseline (Week 0), Week 4, Week 12, Week 16, and 24)
- Psoriasis Area and Severity Index (PASI) Score: Change From Baseline to Weeks 4, 12, 16 and 24(Baseline (Week 0), Week 4, Week 12, Week 16, and 24)
- Disease Activity Score 28, C-reactive Protein (DAS28 [CRP]): Change From Baseline to Weeks 4, 12, 16 and 24(Baseline (Week 0), Week 4, Week 12, Week 16, and 24)
- WPAI:PsA Percentage of OWI: Change From Baseline to Weeks 4, 12, and 16(Baseline (Week 0), Week 4, Week 12, and Week 16)
- WPAI:PsA Presenteeism: Change From Baseline to Weeks 4, 12, 16 and 24(Baseline (Week 0), Week 4, Week 12, Week 16, and 24)
- WPAI:PsA Activity Impairment: Change From Baseline to Weeks 4, 12, 16 and 24(Baseline (Week 0), Week 4, Week 12, Week 16, and 24)
- Disease Activity Score 28, Erythrocyte Sedimentation Rate (DAS28 [ESR]): Change From Baseline to Weeks 4, 12, 16 and 24(Baseline (Week 0), Week 4, Week 12, Week 16, and 24)
- Tender Joint Count (TJC68): Change From Baseline to Weeks 4, 12, 16 and 24(Baseline (Week 0), Week 4, Week 12, Week 16, and 24)
- Swollen Joint Count (SJC66): Change From Baseline to Weeks 4, 12, 16 and 24(Baseline (Week 0), Week 4, Week 12, Week 16, and 24)
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Change From Baseline to Weeks 12 and 24(Baseline (Week 0), Week 12, and Week 24)
- Health Assessment Questionnaire Disability Index (HAQ-DI): Change From Baseline to Weeks 12 and 24(Baseline (Week 0), Week 12, and Week 24)
- Enthesitis: Change From Baseline to Final Visit(Baseline (Week 0) and final visit (up to 24 weeks))
- Dactylitis: Change From Baseline to Final Visit(Baseline (Week 0) and final visit (up to 24 weeks))
- Spondylitis: Change From Baseline to Final Visit(Baseline (Week 0) and final visit (up to 24 weeks))
- Nail Psoriasis: Change From Baseline to Final Visit(Baseline (Week 0) and final visit (up to 24 weeks))
- Number of Participants With Adverse Events (AEs)(From the first dose of study drug until the end of the study (up to 24 weeks))
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