Time to DMARD Treatment and Actual Work Limitation of Patients With Rheumatoid Arthritis in Turkey
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 356
- 试验地点
- 21
- 主要终点
- Evaluation of Disease Duration: Time From Diagnosis to Disease-Modifying Anti-Rheumatic Drug Treatment in Rheumatoid Arthritis
研究概览
简要总结
The objective is to measure time delay from onset of symptoms to diagnosis and time to disease-modifying anti-rheumatic drug treatments in Turkish patients with rheumatoid arthritis. The investigators will also evaluate actual work limitation status of patients and impact of demographic and clinical factors on work limitations in rheumatoid arthritis patients.
详细描述
This post marketing observational study will be conducted in cross-sectional, non-interventional, multi-center format in Turkey. As this is a post marketing observational study, Abbott is not involved in the product supply since the drug is being used according to the approved marketing label and is to be prescribed by the physician under usual and customary practice of physician prescription.
Subjects will be recruited from rheumatology outpatient clinics of university hospitals and/or private offices.
Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data will be included.
Patient data will be collected with a single visit. During the single visit, all required demographic and clinical data will be recorded on the case report forms by the investigators and every subject will be asked to fill out the Work Productivity and Activity Impairment questionnaire and the Health Assessment Questionnaire - Disability Index.
研究设计
- 研究类型
- Observational
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with rheumatoid arthritis by a specialist or by the treating rheumatologist
- •Treated with at least one disease-modifying anti-rheumatic drug or biologics
- •Patients over 18 years
- •Patients already employed at a paid work
- •Patients able to provide data for disease history
- •Able to provide written consent to release information for this study
排除标准
- •Patients who cannot provide necessary outcome measurements for any reason will be excluded from the study
结局指标
主要结局
Evaluation of Disease Duration: Time From Diagnosis to Disease-Modifying Anti-Rheumatic Drug Treatment in Rheumatoid Arthritis
时间窗: Day 1
The time elapsed from diagnosis of rheumatoid arthritis to initiation of treatment with disease-modifying anti-rheumatic drugs (DMARDs).
次要结局
- Work Limitation: Health Assessment Questionnaire-Disability Index (HAQ-DI)(Day 1)
- Work Limitation: Work Productivity and Activity Impairment (WPAI) Questionnaire(Day 1)
- Evaluation of Global Rheumatoid Arthritis Severity Scale(Day 1)
- Evaluation of Disease Activity Score 28 (DAS28)(Day 1)
- Evaluation of Visual Analog Scale (VAS) for Pain and Fatigue(Day 1)
- Number of Disease Modifying Anti-Rheumatic Drugs(Day 1)
- Biologics Usage(Day 1)
- Stiffness Duration(Day 1)
- Number of Comorbidities(Day 1)
- Rheumatoid Factor(Day 1)
- Anti-cyclic Citrullinated Peptide(Day 1)
- Sedimentation Rate(Day 1)
- Number of Deformities at Inspection(Day 1)
- Evaluation of Rheumatoid Arthritis Treatments Duration(Day 1)