Observational Study of Apremilast Use and Effectiveness in Patients With Psoriatic Arthritis in The Netherlands
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 200
- 试验地点
- 11
- 主要终点
- Percentage of patients with a Health Assessment Questionnaire - Disability Index (HAQ-DI) score of ≤ 0.5 or with a decrease of ≥ 0.3 of the HAQ-DI score compared with baseline
研究概览
简要总结
This is a multicenter, prospective, non-interventional, observational single arm study.
100 patients will be recruited in the Netherlands over a one year period. In all cases, the decision to treat the patient with apremilast will be made prior to the decision to enter the subject into this study. Treatment will be according to routine clinical practice and based on recommendations as per the Summary of Product Characteristics (SPC) of apremilast (Otezla®). Each patient will be followed up for a maximum of 24 months.
详细描述
The objective of this non-interventional study is to describe patient reported outcomes, effectiveness and real-life use of apremilast treatment in patients with psoriatic arthritis (PsA).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Refusal to participate in the study.
- •Language barrier for completing the questionnaires.
- •Women who are pregnant or breast-feeding.
- •Hypersensitivity to the active substance or to any of the excipients.
- •Prior exposure to apremilast
- •Initiation of apremilast treatment by a dermatologist for psoriasis
结局指标
主要结局
Percentage of patients with a Health Assessment Questionnaire - Disability Index (HAQ-DI) score of ≤ 0.5 or with a decrease of ≥ 0.3 of the HAQ-DI score compared with baseline
时间窗: Up to 24 months
The HAQ is a general questionnaire to assess physical functioning.
次要结局
- Change from Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) at various time points(Up to 24 months)
- Change from Baseline in EuroQol-5 dimensions (EQ5D) at 12 months(Up to 12 months)
- Change from Baseline in Psoriatic Arthritis Impact of Disease (PsAID) at various time point(Up to 24 months)
- Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at month 6(Up to 6 months)
- Change from Baseline in Dermatology Life Quality Index (DLQI) at month 6(Up to 6 months)
- Change from Baseline in Short Form 36 (SF36) at 12 months(Up to 12 months)
- Change from Baseline in visual analogue scales (VAS) at various time point(Up to 24 months)