临床试验/NCT02335892

NCT02335892已完成不适用

Patient Reported Outcomes With Fingolimod in Local Experience (PROFILE)

Novartis Pharmaceuticals1 个研究点分布在 1 个国家目标入组 114 人开始时间: 2014年11月11日最近更新: 2019年4月1日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Novartis Pharmaceuticals
入组人数: 114
试验地点: 1
主要终点: Changes from baseline after 12 months treatment with Gilenya as measured by the MSIS-29 (physical and psychological domains)

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

Multi centre, prospective, non interventional study in 200-240 UK relapsing remitting multiple sclerosis patients. Patients will complete questionnaires at baseline, 3, 6 and 12 months.

详细描述

Multi centre, prospective, non interventional study in 200-240 UK relapsing remitting multiple sclerosis patients assessing the change in QoL and PRO outcome measures from baseline to 12 months after starting fingolimod. Patients will complete 4 questionnaires at baseline (prior to first fingolimod dose), then repeat them at 3, 6 and 12 month intervals via post.

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 55 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients prescribed Gilenya within the EU licence No previous exposure to Gilenya Patient's HCP considers patient able to complete study questionnaires Patient is between 18-55 years of age -

排除标准

•There are no exclusion criteria for this study.

结局指标

主要结局

Changes from baseline after 12 months treatment with Gilenya as measured by the MSIS-29 (physical and psychological domains)

时间窗: 12 months

次要结局

Treatment Satisfaction Questionnaire for Medication (TSQM) and changes at 3 , 6 and 12mths after Gilenya treatment(12 months)
Changes from Baseline after 3, 6 and 12 months of treatment with Gilenya as measured by EQ-5D-5L(12 months)
MSIS-29 and utility scores measured by EQ-5D-5L and any correlation between them(12 months)
Morisky questionnaire and changes at 3 , 6 and 12 mths after treament with Gilenya(12 months)
Changes from baseline after 3 and 6 months treatment with Gilenya as measured by MSIS-29(12 months)

研究者

发起方

Novartis Pharmaceuticals

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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