To Observe the Impacts of Anti-TNF's Effectiveness on Improvement in Work Place and Household Productivity for Patients With Psoriatic Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 主要终点
- Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) Up to Month 9
研究概览
简要总结
This post marketing observational study is designed to provide the initial data on work impairment of PsA patients in Turkey, as well as changes in work impairment, life quality and clinical response during treatment with anti-TNF agents.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Actively working, either full-time or part-time
- •Previous confirmed diagnosis of PsA by a rheumatologist
- •Patients for whom the physician has initiated PsA treatment with an Anti-TNF in accordance with Turkish Ministry of Health regulations and reimbursement criteria
- •Able to provide authorization to use and disclose their health related information
排除标准
- •Patients with a history of an allergic reaction or significant sensitivity to anti-TNF agents
- •Patients with possible follow-up problems during the planned study period or patients who may not be compliant to treatment as evaluated by the investigator/treating physician
- •Patients participating in any clinical trial of an experimental drug 30 days prior to the baseline visit
结局指标
主要结局
Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) Up to Month 9
时间窗: Baseline, Month 3, Month 6, Month 9
Absenteeism, presented as the mean percentage of work time missed due to PsA (as reported on the WPAI), and calculated as: 100\*number of hours of work missed due to PsA / (number of hours of work missed due to PsA + 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.
WPAI Questionnaire: Mean Percentage of Impairment While Working Due to PsA (Presenteeism) Up to Month 9
时间窗: Baseline, Month 3, Month 6, Month 9
Presenteeism (the extent to which PsA decreased productivity) is presented as the mean percentage of impairment while working due to PsA, 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.
WPAI Questionnaire: Mean Percentage of Activity Impairment Due to PsA Up to Month 9
时间窗: Baseline, Month 3, Month 6, Month 9
Activity impairment due to PsA (the extent to which PsA 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.
WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to PsA Up to Month 9
时间窗: Baseline, Month 3, Month 6, Month 9
The mean percentage of OWPI due to PsA (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) +\[1- Absenteeism(%)\*Presenteeism(%)\]. 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.
次要结局
- Health Assessment Questionnaire Disability Index (HAQ-DI) Score Up to Month 9(Baseline, Month 3, Month 6, Month 9)
- Percentage of Participants With American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Month 9(Month 9)
- Disease Activity Score (DAS 28) Up to Month 9(Baseline, Month 3, Month 6, Month 9)
- Levels of Rheumatoid Factor(Up to Month 9)
- Dactylitis Score Up to Month 9(Baseline, Month 3, Month 6, Month 9)
- Maastricht Ankylosing Spondylitis Enthesitis Scale (MASES) Up to Month 9(Baseline, Month 3, Month 6, Month 9)
- Number of Swollen Joints Up to Month 9(Baseline, Month 3, Month 6, Month 9)
- Participant's Global Assessment of Disease Activity Visual Analog Scale (VAS) Up to Month 9(Baseline, Month 3, Month 6, Month 9)
- Participant's Assessment of Total Back Pain VAS Up to Month 9(Baseline, Month 3, Month 6, Month 9)
- Participant's Assessment of Pain and Fatigue VAS Up to Month 9(Baseline, Month 3, Month 6, Month 9)
- Physician's Global Assessment of Disease Activity VAS Up to Month 9(Baseline, Month 3, Month 6, Month 9)
- Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Treatment-Related Adverse Events (AEs) Up to Month 9(Up to Month 9)
- Number of Tender Joints Up to Month 9(Baseline, Month 3, Month 6, Month 9)
- Participant's Assessment of Nocturnal Back Pain and Fatigue VAS Up to Month 9(Baseline, Month 3, Month 6, Month 9)
- Erythrocyte Sedimentation Rate (ESR) Up to Month 9(Up to Month 9)
- C-reactive Protein (CRP) Up to Month 9(Baseline, Month 3, Month 6, Month 9)