Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis (DEFINE)

January 13, 2015 updated by: Biogen

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine 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. 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 the disease to get worse.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1234

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

  • Australia
      • Fitzroy, Australia
        • Research Site
      • Geelong, Australia
        • Research Site
      • Heidelberg, Australia
        • Research Site
      • Kogarah, Australia
        • Research Site
      • Liverpool, Australia
        • Research Site
      • Melbourne, Australia
        • Research Site
      • Newcastle, Australia
        • Research Site
    • New South Wales
      • Camperdown, New South Wales, Australia
        • Research Site
      • Chatswood, New South Wales, Australia
        • Research Site
  • Austria
      • Graz, Austria
        • Research Site
      • Innsbruck, Austria
        • Research Site
      • Linz, Austria
        • Research Site
    • Vienna
      • Wien, Vienna, Austria
        • Research Site
  • Belgium
      • Antwerpen, Belgium
        • Research Site
      • Brugge, Belgium
        • Research Site
      • Charleroi, Belgium
        • Research Site
      • Diepenbeek, Belgium
        • Research Site
      • Leuven, Belgium
        • Research Site
      • Lommel, Belgium
        • Research Site
      • Sijsele-Damme, Belgium
        • Research Site
      • Woluwe, Belgium
        • Research Site
  • Bosnia and Herzegovina
    • Republic of Srpksa
      • Banja Luka, Republic of Srpksa, Bosnia and Herzegovina
        • Research Site
  • Canada
      • Montreal, Canada
        • Research Site
    • British Columbia
      • Burnaby, British Columbia, Canada
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Research Site
    • Ontario
      • Ottawa, Ontario, Canada
        • Research Site
    • Quebec
      • Levis, Quebec, Canada
        • Research Site
      • Quebec City, Quebec, Canada
        • Research Site
    • Saskatchewan
      • Regina, Saskatchewan, Canada
        • Research Site
  • Croatia
      • Zagreb, Croatia
        • Research Site
  • Czech Republic
      • Brno, Czech Republic
        • Research Site
      • Jihlava, Czech Republic
        • Research Site
      • Opava, Czech Republic
        • Research Site
      • Ostrava, Czech Republic
        • Research Site
      • Plzen, Czech Republic
        • Research Site
      • Praha, Czech Republic
        • Research Site
      • Teplice, Czech Republic
        • Research Site
  • France
      • Clermont Ferrand, France
        • Research Site
      • Nice, France
        • Research Site
      • Paris, France
        • Research Site
      • Rennes, France
        • Research Site
  • Germany
      • Bad Neustadt-Saale, Germany
        • Research Site
      • Berlin, Germany
        • Research Site
      • Bochum, Germany
        • Research Site
      • Dusseldorf, Germany
        • Research Site
      • Essen, Germany
        • Research Site
      • Gieben, Germany
        • Research Site
      • Halle, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Hannover, Germany
        • Research Site
      • Leipzig, Germany
        • Research Site
      • Minden, Germany
        • Research Site
      • Munchen, Germany
        • Research Site
      • Munster, Germany
        • Research Site
      • Osnabruck, Germany
        • Research Site
      • Westerstede, Germany
        • Research Site
  • Greece
      • Athens, Greece
        • Research Site
      • Ioannina, Greece
        • Research Site
      • Thessaloniki, Greece
        • Research Site
  • Guatemala
      • Guatemala City, Guatemala
        • Research Site
  • India
      • Chenna, India
        • Research Site
      • Coimbatore, India
        • Research Site
      • Delhi, India
        • Research Site
      • Hyderabad, India
        • Research Site
      • Kolkata, India
        • Research Site
      • Lucknow, India
        • Research Site
      • Mangalore, India
        • Research Site
      • Mumbai, India
        • Research Site
      • New Delhi, India
        • Research Site
      • Pune, India
        • Research Site
  • Israel
      • Ashkelon, Israel
        • Research Site
      • Beer Yaakov, Israel
        • Research Site
      • Jerusalem, Israel
        • Research Site
      • Tel Hashomer, Israel
        • Research Site
  • Italy
      • Roma, Italy
        • Research Site
  • Macedonia, The Former Yugoslav Republic of
      • Skopje, Macedonia, The Former Yugoslav Republic of
        • Research Site
  • Mexico
      • Guadalajara, Mexico
        • Research Site
      • Mexico City, Mexico
        • Research Site
      • San Luis Potosi, Mexico
        • Research Site
  • Moldova, Republic of
      • Chisinau, Moldova, Republic of
        • Research Site
      • Kishinev, Moldova, Republic of
        • Research Site
  • Netherlands
      • Breda, Netherlands
        • Research Site
      • Sittard, Netherlands
        • Research Site
  • New Zealand
      • Christchurch, New Zealand
        • Research Site
      • Grafton, New Zealand
        • Research Site
      • Hamilton, New Zealand
        • Research Site
  • Poland
      • Bialystok, Poland
        • Research Site
      • Gdansk, Poland
        • Research Site
      • Katowice, Poland
        • Research Site
      • Krakow, Poland
        • Research Site
      • Poznan, Poland
        • Research Site
      • Szczecin, Poland
        • Research Site
      • Warsaw, Poland
        • Research Site
  • Romania
      • Bucuresti, Romania
        • Research Site
      • Cluj-Napoca, Romania
        • Research Site
      • Timisoara, Romania
        • Research Site
  • Serbia
      • Belgrade, Serbia
        • Research Site
      • Kragujevac, Serbia
        • Research Site
      • Nis, Serbia
        • Research Site
      • Novi Sad, Serbia
        • Research Site
  • Slovakia
      • Bratislava, Slovakia
        • Research Site
      • Kosice, Slovakia
        • Research Site
      • Martin, Slovakia
        • Research Site
  • South Africa
      • Cape Town, South Africa
        • Research Site
      • Durban, South Africa
        • Research Site
      • Rosebank, South Africa
        • Research Site
  • Switzerland
      • Basel, Switzerland
        • Research Site
      • St. Gallen, Switzerland
        • Research Site
      • Zurich, Switzerland
        • Research Site
  • Ukraine
      • Kharkiv, Ukraine
        • Research Site
      • Kyiv, Ukraine
        • Research Site
      • Lviv, Ukraine
        • Research Site
      • Odessa, Ukraine
        • Research Site
      • Poltava, Ukraine
        • Research Site
      • Zaporozhye, Ukraine
        • Research Site
  • United Kingdom
      • London, United Kingdom
        • Research Site
      • Newcastle, United Kingdom
        • Research Site
      • Oxford, United Kingdom
        • Research Site
      • Sheffield, United Kingdom
        • Research Site
      • Staffordshire, United Kingdom
        • Research Site
  • United States
    • Arizona
      • Gilbert, Arizona, United States
        • Research Site
      • Phoenix, Arizona, United States
        • Research Site
    • California
      • San Francisco, California, United States
        • Research Site
    • Connecticut
      • New Haven, Connecticut, United States
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, United States
        • Research Site
    • Florida
      • Vero Beach, Florida, United States
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States
        • Research Site
    • Illinois
      • Evanston, Illinois, United States
        • Research Site
      • Palos Heights, Illinois, United States
        • Research Site
    • Indiana
      • Fort Wayne, Indiana, United States
        • Research Site
      • Indianapolis, Indiana, United States
        • Research Site
    • Iowa
      • Des Moines, Iowa, United States
        • Research Site
    • Kansas
      • Wichita, Kansas, United States
        • Research Site
    • Kentucky
      • Lexington, Kentucky, United States
        • Research Site
    • Massachusetts
      • Brighton, Massachusetts, United States
        • Research Site
      • Hopedale, Massachusetts, United States
        • Research Site
      • Lexington, Massachusetts, United States
        • Research Site
      • Springfield, Massachusetts, United States
        • Research Site
      • Worcester, Massachusetts, United States
        • Research Site
    • Michigan
      • Farmington Hills, Michigan, United States
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Research Site
    • Missouri
      • Columbia, Missouri, United States
        • Research Site
      • St. Louis, Missouri, United States
        • Research Site
    • Nevada
      • Henderson, Nevada, United States
        • Research Site
      • Las Vegas, Nevada, United States
        • Research Site
    • New Hampshire
      • Lebanon, New Hampshire, United States
        • Research Site
    • New York
      • Albany, New York, United States
        • Research Site
      • Staten Island, New York, United States
        • Research Site
    • North Carolina
      • Raleigh, North Carolina, United States
        • Research Site
    • Ohio
      • Dayton, Ohio, United States
        • Research Site
    • Pennsylvania
      • Erie, Pennsylvania, United States
        • Research Site
      • Hershey, Pennsylvania, United States
        • Research Site
      • Pittsburgh, Pennsylvania, United States
        • Research Site
    • Rhode Island
      • East Providence, Rhode Island, United States
        • Research Site
      • Providence, Rhode Island, United States
        • Research Site
    • Texas
      • San Antonio, Texas, United States
        • Research Site
    • Virginia
      • Newport News, Virginia, United States
        • Research Site
      • Wien, Virginia, United States
        • Research Site
    • Washington
      • Seattle, Washington, United States
        • Research Site
  • Virgin Islands (U.S.)
      • Vienna, Virgin Islands (U.S.)
        • 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

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion 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:
  • 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.

Key Exclusion Criteria:

  • Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at randomization:
  • Other chronic disease of the immune system, malignancies, acute 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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 neurolgic 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

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 lesion count were calculated from a negative binomial regression model adjusted for region and baselineT2 lesion volume
2 years
Number of Gadolinium-enhancing T1-weighted Lesions
Time Frame: 2 years
The number of Gd-enhancing lesions was assessed using brain MRI scans following administration of gadolinium, a contrast agent. The mean number of Gd-enhancing lesions at 2 years was the average of the number of lesions at 2 years in a treatment group.
2 years
Number of Subjects With Gadolinium (Gd)-Enhancing Lesions
Time Frame: 2 years
Note: This outcome measure represents the categorical analysis for the previously listed secondary outcome measure "Number of Gadolinium-enhancing T1-weighted lesions"
2 years
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 EDSS (≤ 2.0 vs. >2.0), age (<40 versus ≥40 years), region, and the number of relapses in the 1 year prior to enrollment.
2 years
Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS)
Time Frame: 2 years
The EDSS is based on a standardized neurological examination and focuses on symptoms that commonly occur in MS. EDSS 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 a ≥1.5 point increase in subjects with a baseline EDSS = 0, and required that the increase from baseline was confirmed ≥12 weeks 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

January 1, 2007

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

January 8, 2007

First Submitted That Met QC Criteria

January 9, 2007

First Posted (Estimate)

January 11, 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

  • 109MS301

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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