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A Multicenter, Retrospective, Observational Study Evaluating Real-world Clinical Outcomes in Relapsing-remitting Multiple Sclerosis Patients Who Transition From Tysabri® (Natalizumab) to Tecfidera® (Dimethyl Fumarate)
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Research Site
Birmingham, Alabama, United States
Research Site
Cullman, Alabama, United States
Research Site
Gilbert, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Aurora, Colorado, United States
Research Site
Centennial, Colorado, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Jacksonville Beach, Florida, United States
Research Site
Palm Bay, Florida, United States
Research Site
Tampa, Florida, United States
Start Date
July 1, 2014
Primary Completion Date
January 1, 2015
Completion Date
January 1, 2015
Last Updated
June 7, 2016
530
ACTUAL participants
natalizumab
BIOLOGICAL
dimethyl fumarate
DRUG
Lead Sponsor
Biogen
NCT05758831
NCT06586177
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05906992