APPRECIATE (Apremilast Clinical Treatment Experience in Psoriasis): A Multi-center, Retrospective Observational Study of Real-World Experience of Psoriasis Patients Treated With Apremilast in Clinical Dermatology Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 610
- 试验地点
- 133
- 主要终点
- The Patient Benefit Index (PBI) outcome score
研究概览
简要总结
This is a retrospective, multi-center observational cohort study. This study will be implemented first in Germany (approximately 50 sites), the United Kingdom (approximately 20 sites) and Sweden (approximately 25 sites), followed by a selected number of countries in Europe, depending on apremilast local availability. The design of this apremilast retrospective study aims to provide clinical information regarding the treatment initiation and outcomes in psoriasis patients when prescribed apremilast in real world settings. In addition, this study is aiming at capturing physicians' and patients' treatment goals when initiating apremilast and whether these goals are achieved following apremilast use. This study is primarily descriptive in nature, and no a priori hypotheses are specified. Patients must voluntarily sign an informed consent form, be 18 or over, have been diagnosed with plaque psoriasis and have been treated with apremilast during the previous 5-7 months to participate in this study. They must not be involved in any other clinical study involving apremilast.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Must have understood and voluntarily signed the Informed Consent Form (ICF).
- •Age ≥ 18 years at the time of signing the ICF.
- •Diagnosed with plaque psoriasis.
- •Initiated treatment with apremilast 6 months (+/- 1 month) previously (patients may or may not have completed 6 months of apremilast treatment)
排除标准
- •Refusal to participate in this study or current participation in the treatment phase of an interventional clinical trial.
- •Started apremilast as part of a clinical trial.
结局指标
主要结局
The Patient Benefit Index (PBI) outcome score
时间窗: Up to approximately 7 months
Is a questionnaire regarding patient expectations and benefit of psoriasis treatment with apremilast, eg, effect on specific symptoms.
次要结局
- Percentage of patients achieving PASI75(Up to approximately 7 months)
- Percentages of patients achieving ≥5 point improvement in DLQI(Up to approximately 7 months)
- Mean change in Body Surface Area (BSA)(Up to approximately 7 months)
- Treatment Satisfaction Questionnaire for Medication (TSQM) outcome score(Up to approximately 7 months)
- Percentages of patients achieving PASI50 plus ≥5 point improvement in DLQI(Up to approximately 7 months)
- Percentages of patients achieving PASI50(Up to approximately 7 months)
- Mean change in PGA(Up to approximately 7 months)
- Mean change in Dermatology Life Quality Index (DLQI)(Up to approximately 7 months)
- Adverse Events (AEs)(Up to approximately 7 months)
- Percentage of patients achieving PGA 0/1 (clear/almost clear)(Up to approximately 7 months)