Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis
NCT ID: NCT00451451
Last Updated: 2015-01-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1417 participants
INTERVENTIONAL
2007-06-30
2011-08-31
Brief Summary
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Other objectives of the study are to determine the safety and tolerability of BG00012, as well as the effect it may have on tests and evaluations used to assess MS. Additionally, glatiramer acetate is being used to compare its benefits and risks with placebo and BG00012.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BG00012 240 mg Twice Daily (BID)
Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
BG00012
Placebo
BG00012 240 mg 3 Times Daily (TID)
Participants received two 120 mg BG00012 capsules orally three times daily (TID)
BG00012
Placebo
Participants received two placebo capsules orally three times daily (TID)
Placebo
Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)
Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
Glatiramer Acetate
Interventions
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BG00012
Placebo
Glatiramer Acetate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have a baseline EDSS between 0.0 and 5.0, inclusive.
* Must have relapsing-remitting disease course.
Exclusion Criteria
* Pregnant or nursing women
18 Years
55 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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Research Site
Birmingham, Alabama, United States
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Cullman, Alabama, United States
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Huntsville, Alabama, United States
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Phoenix, Arizona, United States
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La Jolla, California, United States
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Loma Linda, California, United States
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Pasadena, California, United States
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Sacramento, California, United States
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Walnut Creek, California, United States
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Boulder, Colorado, United States
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Colorado Springs, Colorado, United States
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Fort Collins, Colorado, United States
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Maitland, Florida, United States
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Miami, Florida, United States
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Naples, Florida, United States
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Pompano Beach, Florida, United States
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Sarasota, Florida, United States
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St. Petersburg, Florida, United States
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Tallahassee, Florida, United States
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Tampa, Florida, United States
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Augusta, Georgia, United States
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Columbus, Georgia, United States
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Meridan, Idaho, United States
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Indianapolis, Indiana, United States
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Kansas City, Kansas, United States
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Louisville, Kentucky, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Clinton Township, Michigan, United States
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Grand Rapids, Michigan, United States
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Dover, New Hampshire, United States
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Lebanon, New Hampshire, United States
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Freehold, New Jersey, United States
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Teaneck, New Jersey, United States
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Amherst, New York, United States
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Buffalo, New York, United States
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Cedarhurst, New York, United States
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Mineola, New York, United States
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Patchogue, New York, United States
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Plainview, New York, United States
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Staten Island, New York, United States
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Stony Brook, New York, United States
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Charlotte, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Bellevue, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Edmond, Oklahoma, United States
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Eugene, Oregon, 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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Souderton, Pennsylvania, United States
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Cordova, Tennessee, United States
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Franklin, Tennessee, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Galveston, Texas, United States
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Houston, Texas, United States
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Round Rock, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Burlington, Vermont, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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Tacoma, Washington, United States
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Homyel, , Belarus
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Minsk, , Belarus
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Vitebsk, , Belarus
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Lommel, , Belgium
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Sijsele-Damme, , Belgium
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Woluwe, , Belgium
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Tuzla, B&H Federation, Bosnia and Herzegovina
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Banja Luka, Republic Srpska, Bosnia and Herzegovina
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Sarajevo B&H Federation, , Bosnia and Herzegovina
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Plovdiv, , Bulgaria
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Rousse, , Bulgaria
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Sofia, , Bulgaria
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Stara Zagora, , Bulgaria
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Varna, , Bulgaria
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Edmonton, , Canada
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London, , Canada
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Montreal, , Canada
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Osijek, , Canada
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San José, , Costa Rica
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Rijeka, , Croatia
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Zagreb, , Croatia
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Ostrava, , Czechia
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Ostrava-Moravska, , Czechia
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Prague, , Czechia
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Kuressaare, , Estonia
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Pärnu, , Estonia
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Tallinn, , Estonia
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Tartu, , Estonia
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Caen, , France
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Dijon, , France
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Marseille, , France
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Montpellier, , France
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Nancy, , France
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Nîmes, , France
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Strasbourg, , France
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Bamberg, , Germany
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Bayreuth, , Germany
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Berg Starnberger, , Germany
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Berlin, , Germany
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Cologne, , Germany
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Düsseldorf, , Germany
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Erbach im Odenwald, , Germany
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Erlangen, , Germany
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Giessen, , Germany
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Halle, , Germany
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Hanburg, , Germany
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Heidelberg, , Germany
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Magdeburg, , Germany
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Marburg, , Germany
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München, , Germany
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Regensburg, , Germany
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Schwerin, , Germany
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Athens, , Greece
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Larissa, , Greece
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Pátrai, , Greece
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Thessaloniki, , Greece
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Ahmedabad, , India
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Bangalore, , India
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Calicut, , India
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Chandigarh, , India
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Chennai, , India
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Coimbatore, , India
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Kochi, , India
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Kolkata, , India
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Lucknow, , India
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Ludhiana, , India
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Mangalore, , India
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Mumbai, , India
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New Delhi, , India
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Pune, , India
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Cork, , Ireland
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Dublin, , Ireland
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Galway, , Ireland
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Holon, , Israel
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Safed, , Israel
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Riga, , Latvia
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Guadalajara, Jalisco, Mexico
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Morelia, Michoacán, Mexico
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Monterrey, Nuevo León, Mexico
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Aguascalientes, , Mexico
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Guadalajara, , Mexico
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Mexico City, , Mexico
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Mexico City, , Mexico
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México, , Mexico
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Monterray, , Mexico
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Chisinau, , Moldova
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Hamilton, , New Zealand
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Skopje, , North Macedonia
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Bialystok, , Poland
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Gdansk, , Poland
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Katowice, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Poznan, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Guaynabo, , Puerto Rico
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Bucharest, , Romania
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Iași, , Romania
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Oradea, , Romania
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Târgu Mureş, , Romania
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Belgrade, , Serbia
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Kragujevac, , Serbia
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Niš, , Serbia
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Novi Sad, , Serbia
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Košice, , Slovakia
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Martin, , Slovakia
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Barcelona, , Spain
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Bilbao, , Spain
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Córdoba, , Spain
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Gandia, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Santiago de Compostela, , Spain
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Seville, , Spain
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Kharkiv, , Ukraine
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Kyiv, , Ukraine
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Lviv, , Ukraine
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Odesa, , Ukraine
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Poltava, , Ukraine
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Simferopol, , Ukraine
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Zaporizhzhya, , Ukraine
Countries
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References
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Amezcua L, Mao-Draayer Y, Vargas WS, Farber R, Schaefer S, Branco F, England SM, Belviso N, Lewin JB, Mendoza JP, Shankar SL; ENDORSE Study Investigators. Efficacy of Dimethyl Fumarate in Young Adults with Relapsing-Remitting Multiple Sclerosis: Analysis of the DEFINE, CONFIRM, and ENDORSE Studies. Neurol Ther. 2023 Jun;12(3):883-897. doi: 10.1007/s40120-023-00475-8. Epub 2023 Apr 15.
Gold R, Arnold DL, Bar-Or A, Fox RJ, Kappos L, Chen C, Parks B, Miller C. Safety and efficacy of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis: 9 years' follow-up of DEFINE, CONFIRM, and ENDORSE. Ther Adv Neurol Disord. 2020 May 12;13:1756286420915005. doi: 10.1177/1756286420915005. eCollection 2020.
Mehta D, Miller C, Arnold DL, Bame E, Bar-Or A, Gold R, Hanna J, Kappos L, Liu S, Matta A, Phillips JT, Robertson D, von Hehn CA, Campbell J, Spach K, Yang L, Fox RJ. Effect of dimethyl fumarate on lymphocytes in RRMS: Implications for clinical practice. Neurology. 2019 Apr 9;92(15):e1724-e1738. doi: 10.1212/WNL.0000000000007262. Epub 2019 Mar 27.
Fox RJ, Gold R, Phillips JT, Okwuokenye M, Zhang A, Marantz JL. Efficacy and Tolerability of Delayed-release Dimethyl Fumarate in Black, Hispanic, and Asian Patients with Relapsing-Remitting Multiple Sclerosis: Post Hoc Integrated Analysis of DEFINE and CONFIRM. Neurol Ther. 2017 Dec;6(2):175-187. doi: 10.1007/s40120-017-0077-5. Epub 2017 Aug 2.
Fernandez O, Giovannoni G, Fox RJ, Gold R, Phillips JT, Potts J, Okwuokenye M, Marantz JL. Efficacy and Safety of Delayed-release Dimethyl Fumarate for Relapsing-remitting Multiple Sclerosis in Prior Interferon Users: An Integrated Analysis of DEFINE and CONFIRM. Clin Ther. 2017 Aug;39(8):1671-1679. doi: 10.1016/j.clinthera.2017.06.012. Epub 2017 Jul 25.
Fox RJ, Chan A, Zhang A, Xiao J, Levison D, Lewin JB, Edwards MR, Marantz JL. Comparative effectiveness using a matching-adjusted indirect comparison between delayed-release dimethyl fumarate and fingolimod for the treatment of multiple sclerosis. Curr Med Res Opin. 2017 Feb;33(2):175-183. doi: 10.1080/03007995.2016.1248380. Epub 2016 Nov 10.
Gold R, Giovannoni G, Phillips JT, Fox RJ, Zhang A, Marantz JL. Sustained Effect of Delayed-Release Dimethyl Fumarate in Newly Diagnosed Patients with Relapsing-Remitting Multiple Sclerosis: 6-Year Interim Results From an Extension of the DEFINE and CONFIRM Studies. Neurol Ther. 2016 Jun;5(1):45-57. doi: 10.1007/s40120-016-0042-8. Epub 2016 Mar 1.
Giovannoni G, Gold R, Fox RJ, Kappos L, Kita M, Yang M, Sarda SP, Zhang R, Viglietta V, Havrdova E. Relapses Requiring Intravenous Steroid Use and Multiple-Sclerosis-related Hospitalizations: Integrated Analysis of the Delayed-release Dimethyl Fumarate Phase III Studies. Clin Ther. 2015 Nov 1;37(11):2543-51. doi: 10.1016/j.clinthera.2015.09.011. Epub 2015 Oct 31.
Fox RJ, Kita M, Cohan SL, Henson LJ, Zambrano J, Scannevin RH, O'Gorman J, Novas M, Dawson KT, Phillips JT. BG-12 (dimethyl fumarate): a review of mechanism of action, efficacy, and safety. Curr Med Res Opin. 2014 Feb;30(2):251-62. doi: 10.1185/03007995.2013.849236. Epub 2013 Oct 22.
Fox RJ, Miller DH, Phillips JT, Hutchinson M, Havrdova E, Kita M, Yang M, Raghupathi K, Novas M, Sweetser MT, Viglietta V, Dawson KT; CONFIRM Study Investigators. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med. 2012 Sep 20;367(12):1087-97. doi: 10.1056/NEJMoa1206328.
Other Identifiers
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109MS302
Identifier Type: -
Identifier Source: org_study_id
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