Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis
CONFIRM
A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis
1 other identifier
interventional
1,417
26 countries
188
Brief Summary
To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. Other goals of the study are to determine if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for MS to get worse. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2007
Typical duration for phase_3
188 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2007
CompletedFirst Posted
Study publicly available on registry
March 23, 2007
CompletedStudy Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
June 2, 2014
CompletedJanuary 26, 2015
January 1, 2015
4.2 years
March 21, 2007
May 5, 2014
January 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Annualized Relapse Rate
A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee. The adjusted annualized relapse rate was calculated from a negative binomial regression model , adjusted for baseline Expanded Disability Status Scale (EDSS ) score(≤2.0 versus\>2.0), age (\<40 versus ≥40 years), region, and the number of relapses in the 1 year prior to enrollment.
2 years
Secondary Outcomes (4)
Number of New or Newly Enlarging T2 Hyperintense Lesions
2 years
Number of New T1 Hypointense Lesions
2 years
Proportion of Subjects Relapsed
2 years
Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS)
2 years
Study Arms (4)
BG00012 240 mg Twice Daily (BID)
EXPERIMENTALParticipants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
BG00012 240 mg 3 Times Daily (TID)
EXPERIMENTALParticipants received two 120 mg BG00012 capsules orally three times daily (TID)
Placebo
PLACEBO COMPARATORParticipants received two placebo capsules orally three times daily (TID)
Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)
ACTIVE COMPARATORParticipants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
Interventions
Eligibility Criteria
You may qualify if:
- Must have 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.
You may not qualify if:
- Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease
- Pregnant or nursing women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (195)
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, 10700, Mexico
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Mexico City, Mexico
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México, 14000, 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
Related Publications (10)
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.
PMID: 37061656DERIVEDGold 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.
PMID: 32426039DERIVEDMehta 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.
PMID: 30918100DERIVEDFox 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.
PMID: 28770420DERIVEDFernandez 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.
PMID: 28751099DERIVEDFox 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.
PMID: 27733070DERIVEDGold 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.
PMID: 26932146DERIVEDGiovannoni 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.
PMID: 26526385DERIVEDFox 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.
PMID: 24131282DERIVEDFox 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.
PMID: 22992072DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Biogen Idec Study Medical Director
- Organization
- Biogen Idec
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2007
First Posted
March 23, 2007
Study Start
June 1, 2007
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
January 26, 2015
Results First Posted
June 2, 2014
Record last verified: 2015-01