Observational Study to Characterize Real-world Clinical Outcomes With Relapsing-remitting Multiple Sclerosis (RRMS)
NCT ID: NCT02776072
Last Updated: 2017-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2978 participants
OBSERVATIONAL
2016-05-31
2016-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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dimethyl fumarate (DMF)
Participants who initiated DMF during the specified time period
No interventions assigned to this group
glatiramer acetate (GA)
Participants who initiated GA during the specified time period
No interventions assigned to this group
teriflunomide
Participants who initiated teriflunomide during the specified time period
No interventions assigned to this group
fingolimod
Participants who initiated fingolimod during the specified time period
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Initiated treatment with DMF, GA, teriflunomide, or fingolimod (defined as index therapy) no earlier than January 2011 and no later than 12 months prior to the date of medical record abstraction (i.e., patient has at least 12 months of data available in the medical record following initiation of index treatment). Note: Patients who have initiated the index therapy but subsequently discontinued or switched to other therapies are allowed in this study as long as there is at least 12 months of follow-up following the initiation of the index therapy.
* Have sufficient available medical records for data abstraction to meet the objectives of the study, i.e., the patient was either under the medical care of the investigating site during the entire period of the index treatment or the patient's complete MS disease and treatment history is otherwise available at the investigating site
Exclusion Criteria
* Have received disease-modifying therapies other than one platform therapy (IFN or GA) prior to initiation of index therapy. In patients for whom GA is index therapy, only one prior IFN therapy is allowed.
* Have received any formulations of DMF, Fumaderm®, or compounded fumarates (e.g., Psorinovo) at any time prior to initiation of treatment with Tecfidera®
* Concurrent enrollment in any interventional clinical trial of an investigational product during time evaluated for medical record abstraction
18 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Homewood, Alabama, United States
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Gilbert, Arizona, United States
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Hanford, California, United States
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Modesto, California, United States
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Santa Ana, California, United States
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Aurora, Colorado, United States
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Danbury, Connecticut, United States
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Hartford, Connecticut, United States
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Jacksonville, Florida, United States
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Port Orange, Florida, United States
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Savannah, Georgia, United States
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Avon, Indiana, United States
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Franklin, Indiana, United States
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Muncie, Indiana, United States
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Overland Park, Kansas, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Wellesley, Massachusetts, United States
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Golden Valley, Minnesota, United States
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Amherst, New York, United States
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New Hyde Park, New York, United States
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New York, New York, United States
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Patchogue, New York, United States
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Raleigh, North Carolina, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Columbus, Ohio, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Mansfield, Texas, United States
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Round Rock, Texas, United States
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Salt Lake City, Utah, United States
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Norfolk, Virginia, United States
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Tacoma, Washington, United States
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
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Ciudad Autonoma Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina
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Córdoba, Córdoba Province, Argentina
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Salta, Salta Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Rosario, Santa Fe Province, Argentina
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New Lambton Heights, New South Wales, Australia
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Box Hill, Victoria, Australia
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Heidelberg, Victoria, Australia
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Melbourne, Victoria, Australia
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Burnaby, British Columbia, Canada
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Saint John, New Brunswick, Canada
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Halifax, Nova Scotia, Canada
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Cambridge, Ontario, Canada
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Guelph, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Gatineau, Quebec, Canada
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Greenfield Park, Quebec, Canada
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Osijek, , Croatia
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Varaždin, , Croatia
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Brno, , Czechia
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Hradec Králové, , Czechia
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Hradec Králové, , Czechia
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Jihlava, , Czechia
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Olomouc, , Czechia
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Ostrava-Poruba, , Czechia
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Pardubice, , Czechia
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Prague, , Czechia
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Teplice, , Czechia
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Libourne, Gironde, France
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Toulouse, Haute Garonne, France
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Le Mans, Sarthe, France
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Le Chesnay, Yvelines, France
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Freiburg im Breisgau, Baden-Wurttemberg, Germany
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Pforzheim, Baden-Wurttemberg, Germany
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Stuttgart, Baden-Wurttemberg, Germany
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Bamberg, Bavaria, Germany
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Potsdam, Brandenburg, Germany
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Hamburg, City state of Hamburg, Germany
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Kassel, Hesse, Germany
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Oldenburg, Lower Saxony, Germany
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Osnabrück, Lower Saxony, Germany
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Stade, Lower Saxony, Germany
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Bochum, North Rhine-Westphalia, Germany
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Düsseldorf, North Rhine-Westphalia, Germany
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Gelsenkirchen, North Rhine-Westphalia, Germany
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Hagen, North Rhine-Westphalia, Germany
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Siegen, North Rhine-Westphalia, Germany
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Sprockhövel, North Rhine-Westphalia, Germany
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Kandel, Rhineland-Palatinate, Germany
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Saint Ingbert, Saarland, Germany
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Leipzig, Saxony, Germany
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Kiel, Schleswig-Holstein, Germany
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Berlin, State of Berlin, Germany
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Berlin, State of Berlin, Germany
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Budapest, , Hungary
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Debrecen, , Hungary
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Eger, , Hungary
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Esztergom, , Hungary
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Kecskemét, , Hungary
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Nyíregyháza, , Hungary
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Cagliari, Cagliari, Italy
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Catania, Catania, Italy
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Napoli, Napoli, Italy
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Napoli, Napoli, Italy
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Alicante, Alicante, Spain
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Badalona, Barcelona, Spain
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Córdoba, Cordoba, Spain
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Santiago de Compostela, La Coruña, Spain
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Madrid, Madrid, Spain
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Málaga, Malaga, Spain
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Vigo, Pontevedra, Spain
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Seville, Sevilla, Spain
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Lausanne, , Switzerland
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Lugano, , Switzerland
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Truro, Cornwall, United Kingdom
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Exeter, Devon, United Kingdom
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Chelmsford, Essex, United Kingdom
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Romford, Essex, United Kingdom
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London, Greater London, United Kingdom
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Glasgow, Strathclyde, United Kingdom
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Chertsey, Surrey, United Kingdom
Countries
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References
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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.
Other Identifiers
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109MS421
Identifier Type: -
Identifier Source: org_study_id
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