Real-World Outcome of Rheumatoid Arthritis Patients in Korea on Adalimumab (ROCKA Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 主要终点
- Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 24
研究概览
简要总结
The study is designed as a prospective, observational study to assess the effect of adalimumab on health-related quality of life (QoL) and work productivity in patients with rheumatoid arthritis (RA) in Korea.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Subject has a diagnosis of RA as defined by the 1987 revised American College of Rheumatology (ACR) classification criteria and/or the ACR/the European League against Rheumatism (EULAR) 2010 classification criteria (any duration since diagnosis).
- •Male or female subject ≥ 18 years of age (local definition according to adalimumab label) who is in compliance with eligibility for adalimumab based on the local label.
- •Patients with moderate to severe RA defined as Disease Activity Score in 28 Joints (DAS28) (ESR) or DAS28 (CRP) > 3.2
- •Biologically treatment naïve and initiated adalimumab at baseline visit
- •Availability of clinical data of the previous 12 weeks prior to baseline
- •Ability to self-complete patient questionnaires
- •Subject must be able and willing to provide written informed consent and comply with the requirements of this study protocol.
排除标准
- •Patients who are pregnant or breast feeding at enrolment or wish to become pregnant in the next 24 weeks.
- •Participation in any RA-related clinical trial at the time of enrolment, at baseline or at any point during the past 24 weeks prior to baseline
- •Patients who in the clinician's view, may not be able to accurately report their QoL or prior resource utilization
- •Patients who in the clinician's view, may not be able to adhere to adalimumab therapy over 24 weeks.
结局指标
主要结局
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 24
时间窗: Baseline and week 24
The HAQ-DI is a patient-reported assessment of physical function that includes 20 items in eight categories representing a comprehensive set of functional activities, including dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Patients were asked about their ability to complete these tasks in the past week using the following 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 (best) to 3 (worst), with a higher score representing a high-dependency disability.
次要结局
- Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12(Baseline and week 12)
- Healthcare Resource Utilization: Number of Participants With Surgery Related to Rheumatoid Arthritis(24 weeks)
- Percentage of Participants Achieving a Clinically Meaningful Improvement on the HAQ-DI at Weeks 12 and 24(Baseline, week 12 and week 24)
- Patient Treatment Satisfaction(Baseline, week 12 and week 24)
- Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary and Mental Component Summary Scores at Weeks 12 and 24(Baseline, week 12, and week 24)
- Healthcare Resource Utilization: Number of Participants With Visits to Healthcare Professionals for Treatment of Rheumatoid Arthritis(24 weeks)
- Healthcare Resource Utilization: Number of Participants With Hospitalization Related to Rheumatoid Arthritis(24 weeks)
- Change From Baseline in EuroQol 5-Dimension 3-Level (EQ-5D-3L) Index at Weeks 12 and 24(Baseline, week 12, and week 24)
- Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) at Weeks 12 and 24(Baseline, week 12, and week 24)
- Healthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid Arthritis(24 weeks)
- Healthcare Resource Utilization: Number of Participants Who Received Concomitant Medications for Rheumatoid Arthritis(24 weeks)