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The primary objective of the study is to evaluate the real-world clinical effectiveness, as measured by the proportion of participants relapsed at 12 months, in participants treated with dimethyl fumarate (DMF).
Secondary objectives of the study are: To evaluate the real-world clinical effectiveness, as measured by the proportion of participants relapsed at 12 months, in participants treated with DMF, glatiramer acetate (GA), teriflunomide, or fingolimod both in the overall participant cohort and in a subset of participants who were naïve to disease-modifying therapy (DMT) and were diagnosed with multiple sclerosis (MS) within 3 years of starting the index therapy; To compare relapse activity, defined as annualized relapse rate (ARR), among participants treated with DMF, GA, teriflunomide, or fingolimod; To compare MS-related hospitalizations among participants treated with DMF, GA, teriflunomide, or fingolimod; To compare intravenous corticosteroid use among participants treated with DMF, GA, teriflunomide, or fingolimod.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dimethyl fumarate (DMF) | Participants who initiated DMF during the specified time period | ||
| glatiramer acetate (GA) | Participants who initiated GA during the specified time period | ||
| teriflunomide | Participants who initiated teriflunomide during the specified time period | ||
| fingolimod | Participants who initiated fingolimod during the specified time period |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants relapsed at 12 months in participants treated with DMF | Single time point per participant retrospective medical record abstraction with no required study visits or procedures | One day |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants relapsed at 12 months treated with index therapy in the overall population as well as the subgroup of MS participants who were naïve to DMTs and were diagnosed with MS within 3 years of starting the index therapy | Single time point per participant retrospective medical record abstraction with no required study visits or procedures | One day |
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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 treated with dimethyl fumarate, fingolimod, teriflunomide, or glatiramer acetate in routine clinical practice.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Homewood | Alabama | 35209 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30706431 | Derived | Min J, Cohan S, Alvarez E, Sloane J, Phillips JT, van der Walt A, Koulinska I, Fang F, Miller C, Chan A. Real-World Characterization of Dimethyl Fumarate-Related Gastrointestinal Events in Multiple Sclerosis: Management Strategies to Improve Persistence on Treatment and Patient Outcomes. Neurol Ther. 2019 Jun;8(1):109-119. doi: 10.1007/s40120-019-0127-2. Epub 2019 Jan 31. |
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| ARR at 12 months in participants treated with index therapy in the overall population as well as in the matched cohorts | Single time point per participant retrospective medical record abstraction with no required study visits or procedures | One day |
| Proportion of relapsed participants with one or more MS-related hospitalizations during the 12 months following treatment initiation in participants treated with index therapy in the overall population and the matched cohorts | Single time point per participant retrospective medical record abstraction with no required study visits or procedures | One day |
| Proportion of relapsed participants requiring treatment with intravenous corticosteroids during the 12 months following treatment initiation in participants treated with index therapy in the overall participant population and the matched cohorts | Single time point per participant retrospective medical record abstraction with no required study visits or procedures | One day |
| Gilbert |
| Arizona |
| 85234 |
| United States |
| Research Site | Hanford | California | 93230 | United States |
| Research Site | Modesto | California | 95355 | United States |
| Research Site | Santa Ana | California | 92704 | United States |
| Research Site | Aurora | Colorado | 80045 | United States |
| Research Site | Danbury | Connecticut | 06810 | United States |
| Research Site | Hartford | Connecticut | 6112 | United States |
| Research Site | Jacksonville | Florida | 32256 | United States |
| Research Site | Port Orange | Florida | 32127 | United States |
| Research Site | Savannah | Georgia | 31406 | United States |
| Research Site | Avon | Indiana | 46123 | United States |
| Research Site | Franklin | Indiana | 46131 | United States |
| Research Site | Muncie | Indiana | 47304 | United States |
| Research Site | Overland Park | Kansas | 66212 | United States |
| Research Site | Boston | Massachusetts | 02135 | United States |
| Research Site | Boston | Massachusetts | 02215 | United States |
| Research Site | Wellesley | Massachusetts | 02481 | United States |
| Research Site | Golden Valley | Minnesota | 55422 | United States |
| Research Site | Amherst | New York | 14226 | United States |
| Research Site | New Hyde Park | New York | 11042 | United States |
| Research Site | New York | New York | 10019 | United States |
| Research Site | Patchogue | New York | 11772 | United States |
| Research Site | Raleigh | North Carolina | 27607-6010 | United States |
| Research Site | Cleveland | Ohio | 44195 | United States |
| Research Site | Columbus | Ohio | 43210 | United States |
| Research Site | Columbus | Ohio | 43221 | United States |
| Research Site | Medford | Oregon | 97504 | United States |
| Research Site | Portland | Oregon | 97225 | United States |
| Research Site | Philadelphia | Pennsylvania | 19107 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15212 | United States |
| Research Site | Dallas | Texas | 75246 | United States |
| Research Site | Houston | Texas | 77018 | United States |
| Research Site | Mansfield | Texas | 76063 | United States |
| Research Site | Round Rock | Texas | 78681 | United States |
| Research Site | Salt Lake City | Utah | 84103 | United States |
| Research Site | Norfolk | Virginia | 23502 | United States |
| Research Site | Tacoma | Washington | 98405 | United States |
| Research Site | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1061ABD | Argentina |
| Research Site | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1425DKT | Argentina |
| Research Site | Ciudad Autonoma Buenos Aires | Ciudad Autonoma Buenos Aires | C1428AQK | Argentina |
| Research Site | Córdoba | Córdoba Province | X5000JHQ | Argentina |
| Research Site | Salta | Salta Province | 4400 | Argentina |
| Research Site | Rosario | Santa Fe Province | 2000 | Argentina |
| Research Site | Rosario | Santa Fe Province | S20000 | Argentina |
| Research Site | New Lambton Heights | New South Wales | 2305 | Australia |
| Research Site | Box Hill | Victoria | 3128 | Australia |
| Research Site | Heidelberg | Victoria | 3084 | Australia |
| Research Site | Melbourne | Victoria | 3050 | Australia |
| Research Site | Burnaby | British Columbia | V5H 4K7 | Canada |
| Research Site | Saint John | New Brunswick | E2L4L2 | Canada |
| Research Site | Halifax | Nova Scotia | B3H4K4 | Canada |
| Research Site | Cambridge | Ontario | N1R7L6 | Canada |
| Research Site | Guelph | Ontario | N1H 4J4 | Canada |
| Research Site | Chicoutimi | Quebec | G7H 5H6 | Canada |
| Research Site | Gatineau | Quebec | J9J 0A5 | Canada |
| Research Site | Greenfield Park | Quebec | J4V 2J2 | Canada |
| Research Site | Osijek | 31000 | Croatia |
| Research Site | Varaždin | 42000 | Croatia |
| Research Site | Brno | 656 91 | Czechia |
| Research Site | Hradec Králové | 500 05 | Czechia |
| Research Site | Hradec Králové | 50003 | Czechia |
| Research Site | Jihlava | 58633 | Czechia |
| Research Site | Olomouc | 775 20 | Czechia |
| Research Site | Ostrava-Poruba | 70800 | Czechia |
| Research Site | Pardubice | 532 03 | Czechia |
| Research Site | Prague | 150 06 | Czechia |
| Research Site | Teplice | 41501 | Czechia |
| Research Site | Libourne | Gironde | 33505 | France |
| Research Site | Toulouse | Haute Garonne | 31059 | France |
| Research Site | Le Mans | Sarthe | 72037 | France |
| Research Site | Le Chesnay | Yvelines | 78157 | France |
| Research Site | Freiburg im Breisgau | Baden-Wurttemberg | 79098 | Germany |
| Research Site | Pforzheim | Baden-Wurttemberg | 75172 | Germany |
| Research Site | Stuttgart | Baden-Wurttemberg | 70182 | Germany |
| Research Site | Bamberg | Bavaria | 96052 | Germany |
| Research Site | Potsdam | Brandenburg | 14471 | Germany |
| Research Site | Hamburg | Free and Hanseatic City of Hamburg | 20249 | Germany |
| Research Site | Kassel | Hesse | 34121 | Germany |
| Research Site | Oldenburg | Lower Saxony | 26122 | Germany |
| Research Site | Osnabrück | Lower Saxony | 49076 | Germany |
| Research Site | Stade | Lower Saxony | 21682 | Germany |
| Research Site | Bochum | North Rhine-Westphalia | 44787 | Germany |
| Research Site | Düsseldorf | North Rhine-Westphalia | 40211 | Germany |
| Research Site | Gelsenkirchen | North Rhine-Westphalia | 45879 | Germany |
| Research Site | Hagen | North Rhine-Westphalia | 58095 | Germany |
| Research Site | Siegen | North Rhine-Westphalia | 57076 | Germany |
| Research Site | Sprockhövel | North Rhine-Westphalia | 45549 | Germany |
| Research Site | Kandel | Rhineland-Palatinate | 76870 | Germany |
| Research Site | Saint Ingbert | Saarland | 66386 | Germany |
| Research Site | Leipzig | Saxony | 04229 | Germany |
| Research Site | Kiel | Schleswig-Holstein | 24105 | Germany |
| Research Site | Berlin | State of Berlin | 10961 | Germany |
| Research Site | Berlin | State of Berlin | 12099 | Germany |
| Research Site | Budapest | 1083 | Hungary |
| Research Site | Debrecen | 4032 | Hungary |
| Research Site | Eger | 3300 | Hungary |
| Research Site | Esztergom | 2500 | Hungary |
| Research Site | Kecskemét | 6000 | Hungary |
| Research Site | Nyíregyháza | 4400 | Hungary |
| Research Site | Cagliari | Cagliari | 09126 | Italy |
| Research Site | Catania | Catania | 95123 | Italy |
| Research Site | Naples | Napoli | 80131 | Italy |
| Research Site | Naples | Napoli | 80138 | Italy |
| Research Site | Alicante | Alicante | 03010 | Spain |
| Research Site | Badalona | Barcelona | 08916 | Spain |
| Research Site | Córdoba | Cordoba | 14011 | Spain |
| Research Site | Santiago de Compostela | La Coruña | 15706 | Spain |
| Research Site | Madrid | Madrid | 28007 | Spain |
| Research Site | Málaga | Malaga | 29010 | Spain |
| Research Site | Vigo | Pontevedra | 36312 | Spain |
| Research Site | Seville | Sevilla | 41071 | Spain |
| Research Site | Lausanne | CH-1011 | Switzerland |
| Research Site | Lugano | 6903 | Switzerland |
| Research Site | Truro | Cornwall | TR1 3LJ | United Kingdom |
| Research Site | Exeter | Devon | EX2 5DW | United Kingdom |
| Research Site | Chelmsford | Essex | CM1 7ET | United Kingdom |
| Research Site | Romford | Essex | RM7 0AG | United Kingdom |
| Research Site | London | Greater London | SW17 0QT | United Kingdom |
| Research Site | Glasgow | Strathclyde | G51 4TF | United Kingdom |
| Research Site | Chertsey | Surrey | KT16 0PZ | United Kingdom |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| 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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