A 2-year HRQL Observational Study Evaluating the Effect of Treatment With Adalimumab on Work Productivity and Sleep in Patients With Rheumatic Diseases in Greece
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 主要终点
- Mean Change From Baseline in Impairment While Working Due to Health Problem
研究概览
简要总结
Treatment with tumor necrosis factor (TNF) inhibitors, especially adalimumab, demonstrated an improvement in work productivity in participants with rheumatic diseases: rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). Limited data was available for the effect of adalimumab treatment on sleep in all three diseases (RA, PsA, and AS) and no data was available for the effect of adalimumab treatment on work productivity in PsA. This long term Health-Related Quality of Life (HRQL) observational study was conducted to evaluate the effect of treatment with adalimumab on work productivity and sleep disturbance in Greek participants with moderate to severe rheumatic diseases (RA, PsA, and AS).
详细描述
This was a multi-center, uncontrolled, prospective, observational study in participants with moderate to severe rheumatic disease (RA, PsA, or AS) who received adalimumab under normal clinical practice in accordance with Summary of Product Characteristics (SmPC), with or without other anti-rheumatic treatments.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with moderate or severe active rheumatic disease, who received adalimumab under normal clinical practice in accordance with the approved local SmPC.
- •Participants who provided their consent for data collection and use by AbbVie.
排除标准
- •Contraindications according to the SmPC.
- •Participants who did not participate in other observational studies conducted by Abbvie.
结局指标
主要结局
Mean Change From Baseline in Impairment While Working Due to Health Problem
时间窗: Baseline (Day 1) and Month 24
The 'impairment while working due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'impairment while working due to health problem' was calculated based on one item: (Q5) to what degree did the disease impair the productivity while working in the past seven days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/ working). The data was calculated using the formula Q5/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Mean Change From Baseline in Overall Work Impairment Due to Health Problem
时间窗: Baseline (Day 1) and Month 24
The 'overall work impairment due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'overall work impairment due to health problem' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit; (Q4) the number of actual work hours in the past seven days from visit; and (Q5) to what degree did the disease impair the productivity while working past seven days from visit). The data was calculated using the formula Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Mean Change From Baseline in Overall Activity Impairment Due to Health Problem
时间窗: Baseline (Day 1) and Month 24
The 'overall activity impairment due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'overall activity impairment due to health problem' was calculated based on one item: (Q6) to what degree did the disease impair the ability to do regular activities in the past seven days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/working). The data was calculated using the formula Q6/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Mean Change From Baseline in Work Time Missed Due to Health Problem
时间窗: Baseline (Day 1) and Month 24
The 'work time missed due to health problem' was assessed using the Work Productivity and Activity Impairment-General Health Problem (WPAI-GHP) questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'work time missed due to health problem' was calculated based on two items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit and (Q4) the number of actual work hours in the past seven days from visit. The data was calculated using the formula Q2/(Q2+Q4) and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
次要结局
- Mean Disease Activity Score 28 (DAS28)(Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24)
- Mean Change From Baseline in Impairment While Working Due to Health Problem by Disease Subgroups(Baseline (Day 1) and Month 24)
- Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score(Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24)
- Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score(Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24)
- Mean Erythrocyte Sedimentation Rate (ESR)(Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24)
- Mean Visual Analogue Scale (VAS) Score(Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24)
- Mean Sleep Disturbance Subscale Score(Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24)
- Mean Change From Baseline in Overall Activity Impairment Due to Health Problem by Disease Subgroups(Baseline (Day 1) and Month 24)
- Mean Change From Baseline in Work Time Missed Due to Health Problem by Disease Subgroups(Baseline (Day 1) and Month 24)
- Mean Plasma Concentrations of C-Reactive Protein (CRP)(Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24)
- Mean Change From Baseline in Overall Work Impairment Due to Health Problem by Disease Subgroups(Baseline (Day 1) and Month 24)
- Percentage of Participants With Tender Joint Count (TJC) and Swollen Joint Count (SJC) Greater Than Zero(Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24)
- Mean Psoriatic Arthritis Response Criteria (PsARC) Score(Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24)