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| ID | Type | Description | Link |
|---|---|---|---|
| US-BGT-13-10564 | Other Identifier | BIIB GMA |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| natalizumab | Biological | Administered as per routine clinical practice |
| |
| dimethyl fumarate | Drug | Administered as per routine clinical practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Kaplan-Meier Estimates for the Proportion of Participants relapsed at 12 months after initiation of treatment with Tecfidera | 12 months post initiation of treatment with Tecfidera |
| Measure | Description | Time Frame |
|---|---|---|
| ARR at 12 months post-initiation of treatment with Tecfidera | 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 | 12 months post initiation of treatment with Tecfidera |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined inclusion/exclusion criteria may apply
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Participants with a diagnosis of RRMS receiving at least 12 months of continuous treatment with Tysabri monotherapy prior to initiation of Tecfidera. Additionally, participants must have initiated treatment with Tecfidera at least 12 months prior to enrollment into the study.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29524759 | Derived | Cohan SL, Moses H, Calkwood J, Tornatore C, LaGanke C, Smoot KE, Meka V, Okwuokenye M, Hotermans C, Mendoza JP, Mann MK, Meltzer LA. Clinical outcomes in patients with relapsing-remitting multiple sclerosis who switch from natalizumab to delayed-release dimethyl fumarate: A multicenter retrospective observational study (STRATEGY). Mult Scler Relat Disord. 2018 May;22:27-34. doi: 10.1016/j.msard.2018.02.028. Epub 2018 Feb 26. |
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| The percent of participants with relapses requiring treatment with intravenous steroids | 12 months post initiation of treatment with Tecfidera |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069442 | Natalizumab |
| D000069462 | Dimethyl Fumarate |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D005650 | Fumarates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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