Observational Study in AS and PsA Patients to Evaluate Work Productivity Before and After the Start of Adalimumab Therapy in Daily Practice in Belgium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 183
- 主要终点
- Change From Baseline at Month 18 in TWPI Due to Disease (Ankylosing Spondylitis and Psoriatic Arthritis Combined)
研究概览
简要总结
This observational study will document to what extent in daily clinical practice the work productivity is affected before and after the start of adalimumab treatment.
Changes in the employment status and work productivity of participants with AS and PsA before and after the start of adalimumab will be noted. The relationship between employment status, work productivity, disease activity and clinical evaluations will be evaluated. Since AS and PsA might be diseases with a strong impact on the daily life of the participant, an evaluation will be performed to the effect of the disease on quality of life and work productivity.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient >= 18 years and <= 50 years
- •Patient diagnosed with AS or PsA
- •Patient to be initiated on adalimumab (according to the Marketing Authorization and Belgian reimbursement criteria)
- •Patient willing to sign informed consent
排除标准
- •Any contraindication for adalimumab as specified in the corresponding Summary of Product Characteristics (SmPC)
- •Patient previously treated with biologics
- •Patient participating in other AbbVie-sponsored trials
结局指标
主要结局
Change From Baseline at Month 18 in TWPI Due to Disease (Ankylosing Spondylitis and Psoriatic Arthritis Combined)
时间窗: Baseline, Month 18
The mean percentage of TWPI due to disease (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which disease decreased productivity (%)\* \[number of hours worked / (number of hours of work missed due to disease + number of hours worked)\]. 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 Month 18.
次要结局
- Change From Baseline at Month 18 in TWPI Due to Disease (Ankylosing Spondylitis and Psoriatic Arthritis Separately)(Baseline, Month 18)
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Scores Over Time (Ankylosing Spondylitis)(Baseline, Months 3, 6, 12, 18)
- Number of Participants Employed at Each Assessed Visit(Baseline, Months 3, 6, 12, 18)
- Percentage of Activity Impairment Due to Disease During the 7 Days Prior to Each Visit(Baseline, Months 3, 6, 12, 18)
- Health Assessment Questionnaire Modified for Spondyloarthropathies (HAQ-S) Scores Over Time (Ankylosing Spondylitis)(Baseline, Months 3, 6, 12, 18)
- Disease Activity Score 28 (DAS-28) Over Time (Psoriatic Arthritis)(Baseline, Months 3, 6, 12, 18)
- Percentage of Missed Working Hours (Absenteeism) Due to Disease 7 Days Prior to Each Visit(Baseline, Months 3, 6, 12, 18)
- Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time (Psoriatic Arthritis)(Baseline, Months 3, 6, 12, 18)
- Dermatology Life Quality Index (DLQI) Scores Over Time (Psoriatic Arthritis)(Baseline, Months 3, 6, 12, 18)
- Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)(Baseline, Months 3, 6, 12, 18)
- Physician's Assessment of Disease Activity Visual Analogue Scale (VAS) Scores Over Time(Baseline, Months 3, 6, 12, 18)
- Percentage of Impairment While Working Due to Disease (Presenteeism) 7 Days Prior to Each Visit(Baseline, Months 3, 6, 12, 18)
- Acute Phase Reactant: Erythrocyte Sedimentation Rate (ESR) Values Over Time(Baseline, Months 3, 6, 12, 18)
- Participant's Assessment of Disease Activity Visual Analogue Scale (VAS) Scores Over Time(Baseline, Months 3, 6, 12, 18)
- Participant's Global Assessment of Pain VAS Scores Over Time(Baseline, Months 3, 6, 12, 18)
- Acute Phase Reactant: C-Reactive Protein (CRP) Values Over Time(Baseline, Months 3, 6, 12, 18)