Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis
NCT ID: NCT00420212
Last Updated: 2015-01-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1234 participants
INTERVENTIONAL
2007-01-31
2011-02-28
Brief Summary
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The purpose of this study is also to determine the safety of BG00012 and how well it is tolerated. Another goal is to see what effect BG00012 may have on tests and evaluations used to assess MS.
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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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Placebo
Participants received two placebo capsules orally three times daily (TID)
Placebo
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
BG00012 240 mg 3 Times Daily (TID)
Participants received two 120 mg BG00012 capsules orally three times daily (TID)
BG00012
Interventions
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BG00012
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.
* 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
Gilbert, Arizona, United States
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Phoenix, Arizona, United States
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San Francisco, California, United States
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New Haven, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Vero Beach, Florida, United States
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Atlanta, Georgia, United States
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Evanston, Illinois, United States
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Palos Heights, Illinois, United States
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Fort Wayne, Indiana, United States
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Indianapolis, Indiana, United States
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Des Moines, Iowa, United States
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Wichita, Kansas, United States
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Lexington, Kentucky, United States
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Brighton, Massachusetts, United States
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Hopedale, Massachusetts, United States
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Lexington, Massachusetts, United States
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Springfield, Massachusetts, United States
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Worcester, Massachusetts, United States
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Farmington Hills, Michigan, United States
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Minneapolis, Minnesota, United States
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Columbia, Missouri, United States
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St Louis, Missouri, United States
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Henderson, Nevada, United States
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Las Vegas, Nevada, United States
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Lebanon, New Hampshire, United States
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Albany, New York, United States
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Staten Island, New York, United States
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Raleigh, North Carolina, United States
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Dayton, Ohio, United States
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Erie, Pennsylvania, United States
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Hershey, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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East Providence, Rhode Island, United States
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Providence, Rhode Island, United States
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San Antonio, Texas, United States
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Newport News, Virginia, United States
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Wien, Virginia, United States
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Seattle, Washington, United States
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Camperdown, New South Wales, Australia
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Chatswood, New South Wales, Australia
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Fitzroy, , Australia
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Geelong, , Australia
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Heidelberg, , Australia
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Kogarah, , Australia
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Liverpool, , Australia
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Melbourne, , Australia
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Newcastle, , Australia
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Vienna, Vienna, Austria
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Graz, , Austria
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Innsbruck, , Austria
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Linz, , Austria
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Antwerp, , Belgium
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Bruges, , Belgium
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Charleroi, , Belgium
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Diepenbeek, , Belgium
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Leuven, , Belgium
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Lommel, , Belgium
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Sijsele-Damme, , Belgium
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Woluwe, , Belgium
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Banja Luka, Republic of Srpksa, Bosnia and Herzegovina
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Burnaby, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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Ottawa, Ontario, Canada
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Lévis, Quebec, Canada
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Québec, Quebec, Canada
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Regina, Saskatchewan, Canada
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Montreal, , Canada
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Zagreb, , Croatia
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Brno, , Czechia
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Jihlava, , Czechia
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Opava, , Czechia
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Ostrava, , Czechia
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Pilsen, , Czechia
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Prague, , Czechia
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Teplice, , Czechia
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Clermont-Ferrand, , France
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Nice, , France
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Paris, , France
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Rennes, , France
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Bad Neustadt-Saale, , Germany
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Berlin, , Germany
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Bochum, , Germany
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Düsseldorf, , Germany
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Essen, , Germany
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Gieben, , Germany
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Halle, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Leipzig, , Germany
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Minden, , Germany
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München, , Germany
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Münster, , Germany
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Osnabrück, , Germany
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Westerstede, , Germany
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Athens, , Greece
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Ioannina, , Greece
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Thessaloniki, , Greece
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Guatemala City, , Guatemala
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Chenna, , India
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Coimbatore, , India
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Delhi, , India
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Hyderabad, , India
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Kolkata, , India
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Lucknow, , 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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Ashkelon, , Israel
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Beer Yaakov, , Israel
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Jerusalem, , Israel
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Tel Litwinsky, , Israel
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Roma, , Italy
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Guadalajara, , Mexico
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Mexico City, , Mexico
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San Luis Potosí City, , Mexico
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Chisinau, , Moldova
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Breda, , Netherlands
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Sittard, , Netherlands
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Christchurch, , New Zealand
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Grafton, , New Zealand
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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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Krakow, , Poland
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Poznan, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Timișoara, , 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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Bratislava, , Slovakia
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Košice, , Slovakia
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Martin, , Slovakia
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Cape Town, , South Africa
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Durban, , South Africa
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Rosebank, , South Africa
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Basel, , Switzerland
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Sankt Gallen, , Switzerland
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Zurich, , Switzerland
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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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Zaporizhzhya, , Ukraine
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London, , United Kingdom
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Newcastle, , United Kingdom
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Oxford, , United Kingdom
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Sheffield, , United Kingdom
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Staffordshire, , United Kingdom
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Vienna, , Virgin Islands
Countries
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References
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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.
Nakamura K, Brown RA, Narayanan S, Collins DL, Arnold DL; Alzheimer's Disease Neuroimaging Initiative. Diurnal fluctuations in brain volume: Statistical analyses of MRI from large populations. Neuroimage. 2015 Sep;118:126-32. doi: 10.1016/j.neuroimage.2015.05.077. Epub 2015 Jun 3.
Kita M, Fox RJ, Gold R, Giovannoni G, Phillips JT, Sarda SP, Kong J, Viglietta V, Sheikh SI, Okwuokenye M, Kappos L. Effects of delayed-release dimethyl fumarate (DMF) on health-related quality of life in patients with relapsing-remitting multiple sclerosis: an integrated analysis of the phase 3 DEFINE and CONFIRM studies. Clin Ther. 2014 Dec 1;36(12):1958-1971. doi: 10.1016/j.clinthera.2014.08.013. Epub 2014 Oct 12.
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.
Gold R, Kappos L, Arnold DL, Bar-Or A, Giovannoni G, Selmaj K, Tornatore C, Sweetser MT, Yang M, Sheikh SI, Dawson KT; DEFINE Study Investigators. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med. 2012 Sep 20;367(12):1098-107. doi: 10.1056/NEJMoa1114287.
Other Identifiers
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109MS301
Identifier Type: -
Identifier Source: org_study_id
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