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.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Key Inclusion Criteria:
- Diagnosis of RRMS per McDonald criteria
- Received at least 12 months of continuous treatment with Tysabri monotherapy prior to
initiation of Tecfidera. Note: continuous treatment with Tysabri is defined as
treatment uninterrupted by other disease-modifying treatment.
- Initiated treatment with Tecfidera at least 12 months prior to enrollment into the
study
- Patient has sufficient available medical records for data abstraction to meet the
objectives of the study
Key Exclusion Criteria:
- Diagnosed with a progressive form of multiple sclerosis (MS) (progressive-relapsing,
primary progressive, secondary progressive)
- Received treatment with any of the following after discontinuation of Tysabri and
before initiation of treatment with Tecfidera (i. e., during washout period):
interferon-beta, glatiramer acetate, fingolimod, teriflunomide, rituximab,
alemtuzumab, ocrelizumab or any investigational compound for the treatment of RRMS
- Received BG00012, or other formulations of dimethyl fumarate, or Fumaderm® or
compounded fumarates at any time prior to initiation of treatment with Tecfidera
- History of progressive multifocal leukoencephalopathy (PML) while on Tysabri or
within 6 months of discontinuing treatment with Tysabri
NOTE: Other protocol-defined inclusion/exclusion criteria may apply
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, 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
Research Site, Athens, Georgia, United States
Research Site, Atlanta, Georgia, United States
Research Site, Idaho Falls, Idaho, United States
Research Site, Chicago, Illinois, United States
Research Site, Peoria, Illinois, United States
Research Site, Baton Rouge, Louisiana, United States
Research Site, Glen Burnie, Maryland, United States
Research Site, Boston, Massachusetts, United States
Research Site, Farmington Hills, Michigan, United States
Research Site, Golden Valley, Minnesota, United States
Research Site, Lincoln, Nebraska, United States
Research Site, Teaneck, New Jersey, United States
Research Site, Amherst, New York, United States
Research Site, East Meadow, New York, United States
Research Site, New York, New York, United States
Research Site, Charlotte, North Carolina, United States
Research Site, Raleigh, North Carolina, United States
Research Site, Columbus, Ohio, United States
Research Site, Gahanna, Ohio, United States
Research Site, Uniontown, Ohio, United States
Research Site, Oklahoma City, Oklahoma, United States
Research Site, Portland, Oregon, United States
Research Site, Altoona, Pennsylvania, United States
Research Site, Pittsburgh, Pennsylvania, United States
Research Site, Nashville, Tennessee, United States
Research Site, Dallas, Texas, United States
Research Site, Salt Lake City, Utah, United States
Research Site, Newport News, Virginia, United States
Research Site, Norfolk, Virginia, United States
Research Site, Seattle, Washington, United States
Research Site, Spokane, Washington, United States
Research Site, Madison, Wisconsin, United States
Research Site, Milwaukee, Wisconsin, United States