临床试验/NCT01272128

NCT01272128已完成不适用

A Multicenter, Prospective Non-interventional Study to Evaluate the Quality of Life in Belgian Patients With CIS or RRMS in Whom Interferon Beta-1a IM Treatment Has Been Initiated

Biogen1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2012年12月最近更新: 2015年10月20日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Biogen
入组人数: 100
试验地点: 1
主要终点: Change from Baseline in EuroQol 5D (EQ-5D) Visual Analog Scale (VAS) at 12 months

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

The primary objective is to assess the quality of life of intramuscular (IM) Interferon Beta-1a in participants with relapsing remitting multiple sclerosis (RRMS) or Clinically Isolated Syndrome (CIS) in a clinical practice setting.

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

•Decision to treat with Interferon Beta-1a (IFN beta-1a) must precede enrollment, independently of the study and in compliance with the marketing authorization
•Study enrollment must occur prior to 4th weekly administration of IFN beta-1a
•Able to understand and complete a self-administered questionnaire
•No contra-indications for IFN beta-1a

排除标准

•Subjects with history of hypersensitivity to natural or recombinant IFN beta or to any component
•Subjects with primary or secondary progressive MS
•Subjects with current severe depression and/or suicidal ideation
•Pregnant women
•Subjects participating in another clinical trial
•Subjects who do not want to participate in the study
•NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

结局指标

主要结局

Change from Baseline in EuroQol 5D (EQ-5D) Visual Analog Scale (VAS) at 12 months

时间窗: Baseline and Month 12

Quality of life will be assessed on a visual analog scale from 0 = worst imaginable health status to 100 = best imaginable health status.

次要结局

Change from Baseline in the Multiple Sclerosis Impact Scale-29 (MSIS-29) score(Baseline and Months 6, 12, 18 and 24)
Correlation between VAS and MSIS29(Baseline and Months 6, 12, 18 and 24)
Change from Baseline in EQ-5D Summary Score(Baseline and Months 6, 12, 18 and 24)
Change from Baseline in EQ-5D VAS at 6, 18 and 24 months(Baseline and Months 6, 18 and 24)
Convenience(Baseline and Months 6, 12, 18 and 24)
Correlation between VAS and Convenience questionnaire(Baseline and Months 6, 12, 18 and 24)

研究者

发起方

Biogen

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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