临床试验/NCT02954081

NCT02954081已完成不适用

Real-world Benefit of Apremilast Treatment of Patients With Moderate-to-severe Psoriasis After Transition From Fumaric Acid Esters

Amgen1 个研究点分布在 1 个国家目标入组 687 人开始时间: 2017年1月26日最近更新: 2023年1月26日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Amgen
入组人数: 687
试验地点: 1
主要终点: Mean absolute value of the overall TSQM score at week 24 of apremilast (APR) therapy (phase II).

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Patient treatment preference and treatment satisfaction of physicians and patients comparing fumaric acid ester therapy with subsequent apremilast treatment

研究设计

研究类型: Observational
观察模型: Other
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

•Adult patients ≥18 years
•Moderate to severe plaque-type psoriasis according to SmPC
•Phase I: Patients will be included once they are started on systemic fumaric acid esters (e.g. Fumaderm initial®) for the treatment of moderate-to-severe psoriasis vulgaris. Patients initiated on fumaric acid esters will be followed for a maximum of 24 weeks during phase I. Patients continued on fumaric acid esters beyond 24 weeks or switched to a therapy other than apremilast during or at the end of the 24-week phase I period will no longer be followed.
•Phase II: Patients switched to apremilast during or at the end of the 24-week phase I period will be included in phase II and followed for additional 32 weeks.
•Written informed consent

排除标准

•Prior treatment with biologics
•According to SmPC
•Participation in another clinical trial (parallel inclusion in the National psoriasis registry PsoBest is allowed)

结局指标

主要结局

Mean absolute value of the overall TSQM score at week 24 of apremilast (APR) therapy (phase II).

时间窗: 56 weeks

次要结局

未报告次要终点

研究者

发起方

Amgen

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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