Real-world Outcomes on Tecfidera (BG00012, Dimethyl Fumarate) Post-Tysabri (BG00002, Natalizumab) (STRATEGY)
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ClinicalTrials.gov Identifier: NCT02159573 |
Recruitment Status :
Completed
First Posted : June 10, 2014
Last Update Posted : June 7, 2016
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Condition or disease | Intervention/treatment |
---|---|
Relapsing-Remitting Multiple Sclerosis | Biological: natalizumab Drug: dimethyl fumarate |
Study Type : | Observational |
Actual Enrollment : | 530 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Official Title: | 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) |
Study Start Date : | July 2014 |
Actual Primary Completion Date : | January 2015 |
Actual Study Completion Date : | January 2015 |

- Biological: natalizumab
Administered as per routine clinical practiceOther Names:
- BG00002
- Tysabri
- Drug: dimethyl fumarate
Administered as per routine clinical practiceOther Names:
- BG00012
- Tecfidera
- DMF
- 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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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02159573
United States, Alabama | |
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Birmingham, Alabama, United States | |
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Cullman, Alabama, United States | |
United States, Arizona | |
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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 | |
United States, District of Columbia | |
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Washington, 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 | |
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Athens, Georgia, United States | |
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Atlanta, Georgia, United States | |
United States, Idaho | |
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Idaho Falls, Idaho, United States | |
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Chicago, Illinois, United States | |
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Peoria, Illinois, United States | |
United States, Louisiana | |
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Baton Rouge, Louisiana, United States | |
United States, Maryland | |
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Glen Burnie, Maryland, United States | |
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Boston, Massachusetts, United States | |
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Farmington Hills, Michigan, United States | |
United States, Minnesota | |
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Golden Valley, Minnesota, United States | |
United States, Nebraska | |
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Lincoln, Nebraska, United States | |
United States, New Jersey | |
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Teaneck, New Jersey, United States | |
United States, New York | |
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Amherst, New York, United States | |
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East Meadow, New York, United States | |
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New York, New York, United States | |
United States, North Carolina | |
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Charlotte, North Carolina, United States | |
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Raleigh, North Carolina, United States | |
United States, Ohio | |
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Columbus, Ohio, United States | |
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Gahanna, Ohio, United States | |
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Uniontown, Ohio, United States | |
United States, Oklahoma | |
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Oklahoma City, Oklahoma, United States | |
United States, Oregon | |
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Portland, Oregon, United States | |
United States, Pennsylvania | |
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Altoona, Pennsylvania, United States | |
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Pittsburgh, Pennsylvania, United States | |
United States, Tennessee | |
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Nashville, Tennessee, United States | |
United States, Texas | |
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Dallas, Texas, United States | |
United States, Utah | |
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Salt Lake City, Utah, United States | |
United States, Virginia | |
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Newport News, Virginia, United States | |
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Norfolk, Virginia, United States | |
United States, Washington | |
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Seattle, Washington, United States | |
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Spokane, Washington, United States | |
United States, Wisconsin | |
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Madison, Wisconsin, United States | |
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Milwaukee, Wisconsin, United States |
Study Director: | Medical Director | Biogen |
Responsible Party: | Biogen |
ClinicalTrials.gov Identifier: | NCT02159573 |
Other Study ID Numbers: |
109MS412 US-BGT-13-10564 ( Other Identifier: BIIB GMA ) |
First Posted: | June 10, 2014 Key Record Dates |
Last Update Posted: | June 7, 2016 |
Last Verified: | June 2016 |
Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases |
Autoimmune Diseases Immune System Diseases Dimethyl Fumarate Natalizumab Immunologic Factors Physiological Effects of Drugs Dermatologic Agents Immunosuppressive Agents |