The Documentation of the Effects on Quality of Life (QOL) and Working Productivity and Activity Impairment (WPAI) in Patients With Rheumatoid Arthritis (RA) Under HUMIRA® (Adalimumab) in Routine Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,088
- 主要终点
- Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score
研究概览
简要总结
This is a single-arm, multi-center, prospective cohort study (post-marketing observational study). The observation period for each participant is 48 weeks.
This study is designed to provide additional data on treatment effects of adalimumab during 48 weeks of treatment in patients with RA under conditions of routine rheumatology care. Course of work productivity and work ability, the course of health-related quality of life, and changes in functionality during 48 weeks treatment with adalimumab are to be documented.
详细描述
This study was designed as a non-interventional observational study. Adalimumab was prescribed in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines.
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
- 15 Years 至 87 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RA patients treated with adalimumab who satisfied the following conditions:
- •Paid worker (PW) RA patients who are engaged in paid work for more than 35 hours per week
- •Home worker (HW)
- •Category 1 unpaid workers; RA patients who are engaged in paid work for less than 35 hours per week
- •Category 2 unpaid workers; RA patients who perform basic activities of daily life (household duties, shopping, child caring, exercise, study, etc.) other than PW
排除标准
- •RA patients showing lowered basic activities of daily life, such as hospitalization and being bedridden
- •RA patients with a history of previous treatment with adalimumab
结局指标
主要结局
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score
时间窗: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)
The HAQ-DI is a patient-reported questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (no disability) to 3 (very severe, high-dependency disability). A negative change from Baseline in the score indicates improvement.
Change From Baseline in WPAI Questionnaire: Mean Percentage of Activity Impairment Due to RA
时间窗: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)
Activity impairment due to RA (the extent to which RA affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, calculated as 100\*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. "Change" was calculated as the value at baseline minus the value at each subsequent time point.
Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism)
时间窗: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of adalimumab (ADA) therapy, and at final assessment (up to Week 48)
Absenteeism, presented as the mean percentage of work time missed due to RA (as reported on the WPAI-RA), and calculated as: 100\*number of hours of work missed due to RA / (number of hours of work missed due to RA + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. "Change" was calculated as the value at baseline minus the value at each subsequent time point.
Change From Baseline in WPAI Questionnaire: Mean Percentage of Impairment While Working Due to RA (Presenteeism)
时间窗: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and at final assessment (up to Week 48)
Presenteeism (the extent to which RA decreased productivity) is presented as the mean percentage of impairment while working due to RA, and calculated as: 100\*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. "Change" was calculated as the value at baseline minus the value at each subsequent time point.
Change From Baseline in WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to RA
时间窗: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and at final assessment (up to Week 48)
The mean percentage of OWPI due to RA (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which RA decreased productivity (%)\* \[number of hours worked / (number of hours of work missed due to RA + number of hours worked)\]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. "Change" was calculated as the value at baseline minus the value at each subsequent time point.
Number of Participants Per Category of the HAQ-DI
时间窗: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)
The HAQ-DI is a patient-reported questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (no disability) to 3 (very severe, high-dependency disability). Categories were defined as: high (\> 1.5), moderate (≤ 1.5 to \> 1.0), low (≤ 1.0 to \> 0.5), remission (≤ 0.5 to \> 0), 0 (0).
次要结局
- Number of Participants Per Category of the DAS28-4 CRP(Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48))
- Number of Participants Per Category of the CDAI(Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48))
- Number of Participants Per Category of the DAS28-4 ESR(Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48))
- Change From Baseline in Disease Activity Score 28-4 C-Reactive Protein (DAS 28-4 CRP)(Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48))
- Change From Baseline in Clinical Disease Activity Index (CDAI)(Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48))
- Change From Baseline in European Quality of Life-5 Dimensions Questionnaire (EQ-5D) Summary Index Score(Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48))
- Change From Baseline in DAS28-4 Erythrocyte Sedimentation Rate (ESR)(Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48))
- Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and Deaths(up to Week 52)
- Number of Participants With Adverse Drug Reactions(up to Week 52)