The primary objective of the study is to evaluate relapse activity, as measured by the proportion of participants relapsed at 12 months, in participants with relapsing-remitting multiple sclerosis (RRMS) who transition from Tysabri (BG00002) to Tecfidera (BG00012) in the real-world setting. The secondary objective is to further evaluate relapse activity, defined as annualized relapse rate (ARR), hospitalization and intravenous corticosteroid use, during the first year of Tecfidera treatment following transition from Tysabri treatment.
The study period will consist of a single time point retrospective medical chart abstraction with no required study visits or procedures. Data collection for this study is expected to last up to approximately five months.
Study Type
OBSERVATIONAL
Enrollment
530
Administered as per routine clinical practice
Administered as per routine clinical practice
Kaplan-Meier Estimates for the Proportion of Participants relapsed at 12 months after initiation of treatment with Tecfidera
Time frame: 12 months post initiation of treatment with Tecfidera
ARR at 12 months post-initiation of treatment with Tecfidera
Time frame: 12 months post initiation of treatment with Tecfidera
The percent of participants with MS-related hospitalization at 12 months post-initiation of treatment with Tecfidera
Time frame: 12 months post initiation of treatment with Tecfidera
The percent of participants with relapses requiring treatment with intravenous steroids
Time frame: 12 months post initiation of treatment with Tecfidera
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Research Site
Birmingham, Alabama, United States
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Cullman, Alabama, United States
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Gilbert, Arizona, United States
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Phoenix, Arizona, United States
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Aurora, Colorado, United States
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Centennial, Colorado, United States
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Washington D.C., District of Columbia, United States
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Jacksonville Beach, Florida, United States
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Palm Bay, Florida, United States
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Tampa, Florida, United States
...and 33 more locations