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This is an observational study to assess the tolerability of Rebif treatment in Korean multiple sclerosis (MS) subjects.
The present observational study is being conducted to assess the safety information from a target of 100 Korean subjects with MS treated with Rebif. Various parameters like subjects' background (age, sex, BMI), MS history, MS status (MS type, Expanded Disability Status Score [EDSS] and others), MS Treatment Concern Questionnaire (MSTCQ), Rebif treatment status, concomitant disease modifying agents (DMA) therapy and Rebif related adverse events will be collected. Subjects will be followed for 12 months. Proportion of subjects with moderate to severe (Grade 3-5) injection site reactions after 3, 6, 12 months of Rebif treatment will be determined. Secondary outcomes like annual relapse rate, change in EDSS, changes in MSTCQ, time to first relapse and incidence of side effects associated with Rebif therapy will also be determined and presented descriptively.
- To assess the tolerability of Rebif treatment in Korean MS subjects in a non-interventional setting Secondary Objectives
- To evaluate subject's satisfaction, clinical data and disease characteristics of the population of MS subjects undergoing Rebif treatment.
Observational Model: Cohort, Time Perspective: Prospective
Samsung Medical Center
50 Ilwon-dong, Gangnam-gu
Korea, Republic of
Published on BioPortfolio: 2014-08-27T03:15:42-0400
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