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

January 13, 2015 updated by: Biogen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1417

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Gomel, Belarus
        • Research Site
      • Minsk, Belarus
        • Research Site
      • Vitebsk, Belarus
        • Research Site
  • Belgium
      • Lommel, Belgium
        • Research Site
      • Sijsele-Damme, Belgium
        • Research Site
      • Woluwe, Belgium
        • Research Site
  • Bosnia and Herzegovina
      • Sarajevo B&H Federation, Bosnia and Herzegovina
        • Research Site
    • B&H Federation
      • Tuzla, B&H Federation, Bosnia and Herzegovina
        • Research Site
    • Republic Srpska
      • Banja Luka, Republic Srpska, Bosnia and Herzegovina
        • Research Site
  • Bulgaria
      • Plovdiv, Bulgaria
        • Research Site
      • Rousse, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
      • Stara Zagora, Bulgaria
        • Research Site
      • Varna, Bulgaria
        • Research Site
  • Canada
      • Edmonton, Canada
        • Research Site
      • London, Canada
        • Research Site
      • Montreal, Canada
        • Research Site
      • Osijek, Canada
        • Research Site
  • Costa Rica
      • San Jose, Costa Rica
        • Research Site
  • Croatia
      • Rijeka, Croatia
        • Research Site
      • Zagreb, Croatia
        • Research Site
  • Czech Republic
      • Ostrava, Czech Republic
        • Research Site
      • Ostrava-Moravska, Czech Republic
        • Research Site
      • Praha, Czech Republic
        • Research Site
  • Estonia
      • Kuressaare, Estonia
        • Research Site
      • Parnu, Estonia
        • Research Site
      • Tallinn, Estonia
        • Research Site
      • Tartu, Estonia
        • Research Site
  • France
      • 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
        • Research Site
  • Germany
      • 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
        • Research Site
  • Greece
      • Athens, Greece
        • Research Site
      • Larisa, Greece
        • Research Site
      • Patra, Greece
        • Research Site
      • Thessaloniki, Greece
        • Research Site
  • India
      • 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
        • Research Site
  • Ireland
      • Cork, Ireland
        • Research Site
      • Dublin, Ireland
        • Research Site
      • Galway, Ireland
        • Research Site
  • Israel
      • Holon, Israel
        • Research Site
      • Safed, Israel
        • Research Site
  • Latvia
      • Riga, Latvia
        • Research Site
  • Macedonia, The Former Yugoslav Republic of
      • Skopje, Macedonia, The Former Yugoslav Republic of
        • Research Site
  • Mexico
      • Aguascalientes, Mexico
        • Research Site
      • Guadalajara, Mexico
        • Research Site
      • Mexico, Mexico, 14000
        • Research Site
      • Mexico DF, Mexico, 10700
        • Research Site
      • Mexico DF, Mexico
        • Research Site
      • Monterray, Mexico
        • Research Site
    • Jal
      • Guadalajara, Jal, Mexico
        • Research Site
    • Michoacan
      • Morelia, Michoacan, Mexico
        • Research Site
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico
        • Research Site
  • Moldova, Republic of
      • Chisinau, Moldova, Republic of
        • Research Site
      • Kishinev, Moldova, Republic of
        • Research Site
  • New Zealand
      • Hamilton, New Zealand
        • Research Site
  • Poland
      • 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
        • Research Site
  • Puerto Rico
      • Guaynabo, Puerto Rico
        • Research Site
  • Romania
      • Bucuresti, Romania
        • Research Site
      • Iasi, Romania
        • Research Site
      • Oradea, Romania
        • Research Site
      • Tirgu Mures, Romania
        • Research Site
      • Tirgu-Mures, Romania
        • Research Site
  • Serbia
      • Belgrade, Serbia
        • Research Site
      • Kragujevac, Serbia
        • Research Site
      • Nis, Serbia
        • Research Site
      • Novi Sad, Serbia
        • Research Site
  • Slovakia
      • Kosice, Slovakia
        • Research Site
      • Martin, Slovakia
        • Research Site
  • Spain
      • 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
        • Research Site
  • Ukraine
      • 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
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Research Site
      • Cullman, Alabama, United States
        • Research Site
      • Huntsville, Alabama, United States
        • Research Site
    • Arizona
      • Phoenix, Arizona, United States
        • Research Site
    • California
      • 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
        • Research Site
    • Colorado
      • Boulder, Colorado, United States
        • Research Site
      • Colorado Springs, Colorado, United States
        • Research Site
      • Fort Collins, Colorado, United States
        • Research Site
    • Florida
      • 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
        • Research Site
    • Georgia
      • Augusta, Georgia, United States
        • Research Site
      • Columbus, Georgia, United States
        • Research Site
    • Idaho
      • Meridan, Idaho, United States
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States
        • Research Site
    • Kansas
      • Kansas City, Kansas, United States
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States
        • Research Site
    • Louisiana
      • Shreveport, Louisiana, United States
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • Research Site
    • Michigan
      • Clinton Township, Michigan, United States
        • Research Site
      • Grand Rapids, Michigan, United States
        • Research Site
    • New Hampshire
      • Dover, New Hampshire, United States
        • Research Site
      • Lebanon, New Hampshire, United States
        • Research Site
    • New Jersey
      • Freehold, New Jersey, United States
        • Research Site
      • Teaneck, New Jersey, United States
        • Research Site
    • New York
      • 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
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States
        • Research Site
      • Winston-Salem, North Carolina, United States
        • Research Site
    • Ohio
      • Bellevue, Ohio, United States
        • Research Site
      • Cleveland, Ohio, United States
        • Research Site
      • Columbus, Ohio, United States
        • Research Site
    • Oklahoma
      • Edmond, Oklahoma, United States
        • Research Site
    • Oregon
      • Eugene, Oregon, United States
        • Research Site
      • Medford, Oregon, United States
        • Research Site
      • Portland, Oregon, United States
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Research Site
      • Pittsburgh, Pennsylvania, United States
        • Research Site
      • Souderton, Pennsylvania, United States
        • Research Site
    • Tennessee
      • 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
        • Research Site
    • Texas
      • 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
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States
        • Research Site
    • Vermont
      • Burlington, Vermont, United States
        • Research Site
    • Virginia
      • Richmond, Virginia, United States
        • Research Site
    • Washington
      • Seattle, Washington, United States
        • Research Site
      • Tacoma, Washington, United States
        • Research Site
    • Wisconsin
      • Madison, Wisconsin, United States
        • Research Site
      • Milwaukee, Wisconsin, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants received two placebo capsules orally three times daily (TID)
Drug: Placebo
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: Placebo
Drug: BG00012
Other Names:
  • Tecfidera®
  • dimethyl fumarate
Experimental: BG00012 240 mg 3 Times Daily (TID)
Participants received two 120 mg BG00012 capsules orally three times daily (TID)
Drug: BG00012
Other Names:
  • Tecfidera®
  • dimethyl fumarate
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualized Relapse Rate
Time Frame: 2 years

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of New or Newly Enlarging T2 Hyperintense Lesions
Time Frame: 2 years
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.
2 years
Number of New T1 Hypointense Lesions
Time Frame: 2 years
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.
2 years
Proportion of Subjects Relapsed
Time Frame: 2 years
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.
2 years
Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS)
Time Frame: 2 years
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

March 21, 2007

First Submitted That Met QC Criteria

March 22, 2007

First Posted (Estimate)

March 23, 2007

Study Record Updates

Last Update Posted (Estimate)

January 26, 2015

Last Update Submitted That Met QC Criteria

January 13, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 109MS302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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