Real-World Outcome of Psoriasis Patients in Korea on Adalimumab
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 12
- 主要终点
- Change in EuroQol 5 dimension (EQ-5D) score up to week 24
研究概览
简要总结
The objective of this non-interventional, observational study is to assess the effect of adalimumab on health-related quality of life in participants with Psoriasis in Korea.
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
- 19 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has a diagnosis of Psoriasis by investigator.
- •Participant (local definition according to adalimumab label) who is in compliance with eligibility for adalimumab based on the local label.
- •Participant must be able and willing to provide written informed consent and comply with the requirements of this study protocol.
排除标准
- •Participants who are pregnant or breast feeding at enrolment or wish to become pregnant in the next 24 weeks.
- •Participation in any Psoriasis-related clinical trial at the time of enrolment, at baseline or at any point during the study period.
- •Participants, who in the investigator's view, may not be able to accurately report their questionnaires
结局指标
主要结局
Change in EuroQol 5 dimension (EQ-5D) score up to week 24
时间窗: From Week 0 (baseline) to 24
The EQ-5D measures the subject's overall health state in a descriptive system of health-related quality of life (QoL) states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which can take one of three responses. The responses record three levels of severity ('no problems', 'some problems', and 'extreme problems) within a particular EQ-5D dimension. The EQ-5D results can be converted to health utility scores. Completion time for the EQ-5D is approximately 2-3 minutes.
次要结局
- Change in EuroQol 5 dimension (EQ-5D) score up to week 16(From Week 0 (baseline) to 16)
- Change in PASI score(Week 0 (baseline), Week 16, and Week 24)
- Percentage of participants achieving Psoriasis Area and Severity Index (PASI) 90(Up to Week 24)
- Change in Short Form (36) Health Survey (SF-36) domain scales(Week 0 (baseline), Week 16, Week 24)
- Change in Dermatology Life Quality Index (DLQI)(Week 0 (baseline), Week 16, Week 24)
- Percentage of participants achieving Psoriasis Area and Severity Index (PASI) 100(Up to Week 24)
- Change in subject satisfaction questions(Week 0 (baseline), Week 16, and Week 24)
- Change in EQ-5D Visual Analogue Scale (VAS)(Week 0 (baseline), Week 16, Week 24)
- Percentage of participants achieving Psoriasis Area and Severity Index (PASI) 75(Up to Week 24)
- Change in Nail Psoriasis Severity Index (NAPSI) score in participants with nail psoriasis(Week 0 (baseline), Week 16, Week 24)