Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis (CONFIRM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00451451
First received: March 21, 2007
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Relapsing-Remitting Multiple Sclerosis
Drug: BG00012
Drug: Placebo
Drug: Glatiramer Acetate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Annualized Relapse Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Number of New or Newly Enlarging T2 Hyperintense Lesions [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The number of new or newly enlarging T2 hyperintense lesions at 2 years that developed in each subject compared to baseline assessed on brain magnetic resonance imaging (MRI) scans. The estimates of mean T2 hyperintense lesion count were calculated from a negative binomial regression model adjusted for region and baseline T2 hyperintense lesion volume.

  • Number of New T1 Hypointense Lesions [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The number of new T1 hypointense lesions at 2 years that developed in each subject compared to baseline assessed on brain magnetic resonance imaging (MRI) scans. The estimates of mean T1 hypointense lesion count were calculated from a negative binomial regression model adjusted for region and baseline T1 hypointense lesion volume.

  • Proportion of Subjects Relapsed [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 proportion of subjects with a relapse was estimated using the Kaplan-Meier method, which was based on the time-to-first-relapse survival distribution.

  • Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    EDSS is based on a standardized neurological exam and focuses on symptoms that commonly occur in MS. Scores range from 0.0 (normal) to 10.0 (death due to MS). Disability progression was defined as ≥ 1.0 point increase in subjects with a baseline EDSS of ≥1.0, or ≥1.5 point increase in subjects with a baseline EDSS=0, and required that the increase from baseline was confirmed ≥ 12weeks later. The proportion of subjects with confirmed (12-week) disability progression was estimated using the Kaplan-Meier method, which was based on the time-to-first-progression survival distribution


Enrollment: 1417
Study Start Date: June 2007
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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)
Drug: BG00012
Other Names:
  • dimethyl fumarate
  • Tecfidera®
Drug: Placebo
Experimental: BG00012 240 mg 3 Times Daily (TID)
Participants received two 120 mg BG00012 capsules orally three times daily (TID)
Drug: BG00012
Other Names:
  • dimethyl fumarate
  • Tecfidera®
Placebo Comparator: Placebo
Participants received two placebo capsules orally three times daily (TID)
Drug: Placebo
Active Comparator: Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)
Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
Drug: Glatiramer Acetate

Detailed Description:

Multiple sclerosis (MS) is a chronic disease of the central nervous system that affects approximately 400,000 persons in North America and 365,000 persons in Europe. It is predominantly a disease of young adults, primarily women, with disease onset typically occurring between the ages of 20 and 40.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease
  • Pregnant or nursing women

Note: Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00451451

  Hide Study Locations
Locations
United States, Alabama
Research Site
Birmingham, Alabama, United States
Research Site
Cullman, Alabama, United States
Research Site
Huntsville, Alabama, United States
United States, Arizona
Research Site
Phoenix, Arizona, United States
United States, California
Research Site
La Jolla, California, United States
Research Site
Loma Linda, California, United States
Research Site
Pasadena, California, United States
Research Site
Sacramento, California, United States
Research Site
Walnut Creek, California, United States
United States, Colorado
Research Site
Boulder, Colorado, United States
Research Site
Colorado Springs, Colorado, United States
Research Site
Fort Collins, Colorado, United States
United States, Florida
Research Site
Maitland, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Naples, Florida, United States
Research Site
Pompano Beach, Florida, United States
Research Site
Sarasota, Florida, United States
Research Site
St. Petersburg, Florida, United States
Research Site
Tallahassee, Florida, United States
Research Site
Tampa, Florida, United States
United States, Georgia
Research Site
Augusta, Georgia, United States
Research Site
Columbus, Georgia, United States
United States, Idaho
Research Site
Meridan, Idaho, United States
United States, Indiana
Research Site
Indianapolis, Indiana, United States
United States, Kansas
Research Site
Kansas City, Kansas, United States
United States, Kentucky
Research Site
Louisville, Kentucky, United States
United States, Louisiana
Research Site
Shreveport, Louisiana, United States
United States, Maryland
Research Site
Baltimore, Maryland, United States
United States, Massachusetts
Research Site
Boston, Massachusetts, United States
United States, Michigan
Research Site
Clinton Township, Michigan, United States
Research Site
Grand Rapids, Michigan, United States
United States, New Hampshire
Research Site
Dover, New Hampshire, United States
Research Site
Lebanon, New Hampshire, United States
United States, New Jersey
Research Site
Freehold, New Jersey, United States
Research Site
Teaneck, New Jersey, United States
United States, New York
Research Site
Amherst, New York, United States
Research Site
Buffalo, New York, United States
Research Site
Cedarhurst, New York, United States
Research Site
Mineola, New York, United States
Research Site
Patchogue, New York, United States
Research Site
Plainview, New York, United States
Research Site
Staten Island, New York, United States
Research Site
Stony Brook, New York, United States
United States, North Carolina
Research Site
Charlotte, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
United States, Ohio
Research Site
Bellevue, Ohio, United States
Research Site
Cleveland, Ohio, United States
Research Site
Columbus, Ohio, United States
United States, Oklahoma
Research Site
Edmond, Oklahoma, United States
United States, Oregon
Research Site
Eugene, Oregon, United States
Research Site
Medford, Oregon, United States
Research Site
Portland, Oregon, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Souderton, Pennsylvania, United States
United States, Tennessee
Research Site
Cordova, Tennessee, United States
Research Site
Franklin, Tennessee, United States
Research Site
Knoxville, Tennessee, United States
Research Site
Memphis, Tennessee, United States
Research Site
Nashville, Tennessee, United States
United States, Texas
Research Site
Dallas, Texas, United States
Research Site
Galveston, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Round Rock, Texas, United States
Research Site
San Antonio, Texas, United States
United States, Utah
Research Site
Salt Lake City, Utah, United States
United States, Vermont
Research Site
Burlington, Vermont, United States
United States, Virginia
Research Site
Richmond, Virginia, United States
United States, Washington
Research Site
Seattle, Washington, United States
Research Site
Tacoma, Washington, United States
United States, Wisconsin
Research Site
Madison, Wisconsin, United States
Research Site
Milwaukee, Wisconsin, United States
Belarus
Research Site
Gomel, Belarus
Research Site
Minsk, Belarus
Research Site
Vitebsk, Belarus
Belgium
Research Site
Lommel, Belgium
Research Site
Sijsele-Damme, Belgium
Research Site
Woluwe, Belgium
Bosnia and Herzegovina
Research Site
Tuzla, B&H Federation, Bosnia and Herzegovina
Research Site
Banja Luka, Republic Srpska, Bosnia and Herzegovina
Research Site
Sarajevo B&H Federation, Bosnia and Herzegovina
Bulgaria
Research Site
Plovdiv, Bulgaria
Research Site
Rousse, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Stara Zagora, Bulgaria
Research Site
Varna, Bulgaria
Canada
Research Site
Edmonton, Canada
Research Site
London, Canada
Research Site
Montreal, Canada
Research Site
Osijek, Canada
Costa Rica
Research Site
San Jose, Costa Rica
Croatia
Research Site
Rijeka, Croatia
Research Site
Zagreb, Croatia
Czech Republic
Research Site
Ostrava, Czech Republic
Research Site
Ostrava-Moravska, Czech Republic
Research Site
Praha, Czech Republic
Estonia
Research Site
Kuressaare, Estonia
Research Site
Parnu, Estonia
Research Site
Tallinn, Estonia
Research Site
Tartu, Estonia
France
Research Site
Caen, France
Research Site
Dijon, France
Research Site
Marseille, France
Research Site
Montpellier, France
Research Site
Nancy, France
Research Site
Nimes, France
Research Site
Strasbourg, France
Germany
Research Site
Bamberg, Germany
Research Site
Bayreuth, Germany
Research Site
Berg Starnberger, Germany
Research Site
Berlin, Germany
Research Site
Dusseldorf, Germany
Research Site
Erbach, Germany
Research Site
Erlangen, Germany
Research Site
Giessen, Germany
Research Site
Halle (Saale), Germany
Research Site
Hanburg, Germany
Research Site
Heidelberg, Germany
Research Site
Koln, Germany
Research Site
Magdeburg, Germany
Research Site
Marburg, Germany
Research Site
Munchen, Germany
Research Site
Regensburg, Germany
Research Site
Schwerin, Germany
Greece
Research Site
Athens, Greece
Research Site
Larisa, Greece
Research Site
Patra, Greece
Research Site
Thessaloniki, Greece
India
Research Site
Ahmedabad, India
Research Site
Bangalore, India
Research Site
Calicut, India
Research Site
Chandigarh, India
Research Site
Chennai, India
Research Site
Cochin, India
Research Site
Coimbatore, India
Research Site
Kochi, India
Research Site
Kolkata, India
Research Site
Lucknow, India
Research Site
Ludhiana, India
Research Site
Mangalore, India
Research Site
Mumbai, India
Research Site
New Delhi, India
Research Site
Pune, India
Ireland
Research Site
Cork, Ireland
Research Site
Dublin, Ireland
Research Site
Galway, Ireland
Israel
Research Site
Holon, Israel
Research Site
Safed, Israel
Latvia
Research Site
Riga, Latvia
Macedonia, The Former Yugoslav Republic of
Research Site
Skopje, Macedonia, The Former Yugoslav Republic of
Mexico
Research Site
Guadalajara, Jal, Mexico
Research Site
Morelia, Michoacan, Mexico
Research Site
Monterrey, Nuevo Leon, Mexico
Research Site
Aguascalientes, Mexico
Research Site
Guadalajara, Mexico
Research Site
Mexico, Mexico, 14000
Research Site
Mexico DF, Mexico
Research Site
Mexico DF, Mexico, 10700
Research Site
Monterray, Mexico
Moldova, Republic of
Research Site
Chisinau, Moldova, Republic of
Research Site
Kishinev, Moldova, Republic of
New Zealand
Research Site
Hamilton, New Zealand
Poland
Research Site
Bialystok, Poland
Research Site
Gdansk, Poland
Research Site
Katowice, Poland
Research Site
Lodz, Poland
Research Site
Lublin, Poland
Research Site
Poznan, Poland
Research Site
Szczecin, Poland
Research Site
Warsaw, Poland
Research Site
Warszawa, Poland
Research Site
Wroclaw, Poland
Puerto Rico
Research Site
Guaynabo, Puerto Rico
Romania
Research Site
Bucuresti, Romania
Research Site
Iasi, Romania
Research Site
Oradea, Romania
Research Site
Tirgu Mures, Romania
Research Site
Tirgu-Mures, Romania
Serbia
Research Site
Belgrade, Serbia
Research Site
Kragujevac, Serbia
Research Site
Nis, Serbia
Research Site
Novi Sad, Serbia
Slovakia
Research Site
Kosice, Slovakia
Research Site
Martin, Slovakia
Spain
Research Site
Barcelona, Spain
Research Site
Bilbao, Spain
Research Site
Cordoba, Spain
Research Site
Gandia, Spain
Research Site
Madrid, Spain
Research Site
Malaga, Spain
Research Site
Santiago de Compostela, Spain
Research Site
Sevilla, Spain
Ukraine
Research Site
Kharkiv, Ukraine
Research Site
Kyiv, Ukraine
Research Site
Lviv, Ukraine
Research Site
Odessa, Ukraine
Research Site
Poltava, Ukraine
Research Site
Simferopol, Ukraine
Research Site
Zaporozhye, Ukraine
Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Medical Director Biogen Idec
  More Information

No publications provided by Biogen Idec

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT00451451     History of Changes
Other Study ID Numbers: 109MS302
Study First Received: March 21, 2007
Results First Received: May 5, 2014
Last Updated: May 5, 2014
Health Authority: Romania: National Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Ukraine: State Pharmacological Center - Ministry of Health
Ireland: Irish Medicines Board
Mexico: Federal Commission for Protection Against Health Risks
Bulgaria: Ministry of Health
Spain: Spanish Agency of Medicines
Estonia: The State Agency of Medicine
United States: Institutional Review Board
New Zealand: Medsafe
Czech Republic: State Institute for Drug Control
Greece: National Organization of Medicines
Slovakia: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Croatia: Ministry of Health and Social Care
Canada: Health Canada
Latvia: State Agency of Medicines
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United States: Food and Drug Administration
Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by Biogen Idec:
relapsing
multiple sclerosis
oral
remitting

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Dimethyl fumarate
Copolymer 1
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on July 29, 2014