Back to resultsEfficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis (DEFINE)
Primary Purpose
Relapsing-Remitting Multiple Sclerosis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BG00012
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Relapsing-Remitting Multiple Sclerosis focused on measuring relapsing, oral, remitting, multiple sclerosis
Eligibility Criteria
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.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
BG00012 240 mg Twice Daily (BID)
BG00012 240 mg 3 Times Daily (TID)
Arm Description
Participants received two placebo capsules orally three times daily (TID)
Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
Participants received two 120 mg BG00012 capsules orally three times daily (TID)
Outcomes
Primary Outcome Measures
Proportion of Subjects Relapsed
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.
Secondary Outcome Measures
Number of New or Newly Enlarging T2 Hyperintense Lesions
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
Number of Gadolinium-enhancing T1-weighted Lesions
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.
Number of Subjects With Gadolinium (Gd)-Enhancing Lesions
Note: This outcome measure represents the categorical analysis for the previously listed secondary outcome measure "Number of Gadolinium-enhancing T1-weighted lesions"
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 EDSS (≤ 2.0 vs. >2.0), age (<40 versus ≥40 years), region, and the number of relapses in the 1 year prior to enrollment.
Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00420212
Brief Title
Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis
Acronym
DEFINE
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing-Remitting Multiple Sclerosis
Keywords
relapsing, oral, remitting, multiple sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1234 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received two placebo capsules orally three times daily (TID)
Arm Title
BG00012 240 mg Twice Daily (BID)
Arm Type
Experimental
Arm Description
Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
Arm Title
BG00012 240 mg 3 Times Daily (TID)
Arm Type
Experimental
Arm Description
Participants received two 120 mg BG00012 capsules orally three times daily (TID)
Intervention Type
Drug
Intervention Name(s)
BG00012
Other Intervention Name(s)
dimethyl fumarate, Tecfidera®
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Proportion of Subjects Relapsed
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Number of New or Newly Enlarging T2 Hyperintense Lesions
Description
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
Time Frame
2 years
Title
Number of Gadolinium-enhancing T1-weighted Lesions
Description
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.
Time Frame
2 years
Title
Number of Subjects With Gadolinium (Gd)-Enhancing Lesions
Description
Note: This outcome measure represents the categorical analysis for the previously listed secondary outcome measure "Number of Gadolinium-enhancing T1-weighted lesions"
Time Frame
2 years
Title
Annualized Relapse Rate
Description
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.
Time Frame
2 years
Title
Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS)
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Gilbert
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Arizona
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United States
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Phoenix
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Arizona
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United States
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San Francisco
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California
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United States
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New Haven
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Connecticut
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United States
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Washington
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District of Columbia
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United States
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Vero Beach
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Florida
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United States
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Atlanta
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Georgia
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United States
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Evanston
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Illinois
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United States
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Palos Heights
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Illinois
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United States
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Fort Wayne
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Indiana
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United States
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Indianapolis
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Indiana
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United States
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Des Moines
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Iowa
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United States
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Wichita
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Kansas
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United States
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Lexington
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Kentucky
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United States
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Brighton
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Massachusetts
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United States
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Hopedale
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Massachusetts
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United States
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Lexington
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Massachusetts
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United States
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Springfield
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Massachusetts
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United States
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Worcester
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Massachusetts
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United States
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Farmington Hills
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Michigan
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United States
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Minneapolis
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Minnesota
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United States
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Columbia
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Missouri
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United States
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St. Louis
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Missouri
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United States
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Henderson
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Nevada
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United States
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Las Vegas
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United States
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Lebanon
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New Hampshire
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United States
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Albany
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New York
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United States
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Staten Island
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New York
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United States
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Raleigh
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North Carolina
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United States
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Dayton
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Ohio
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United States
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Erie
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Pennsylvania
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United States
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Hershey
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Pennsylvania
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United States
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Pittsburgh
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Pennsylvania
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United States
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East Providence
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Rhode Island
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United States
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Providence
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Rhode Island
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United States
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San Antonio
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Texas
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United States
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Newport News
State/Province
Virginia
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United States
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Wien
State/Province
Virginia
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United States
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Seattle
State/Province
Washington
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United States
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Camperdown
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New South Wales
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Australia
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Chatswood
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New South Wales
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Australia
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Fitzroy
Country
Australia
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Geelong
Country
Australia
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Heidelberg
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Australia
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Kogarah
Country
Australia
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Liverpool
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Australia
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Melbourne
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Australia
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Newcastle
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Australia
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Wien
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Vienna
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Austria
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Graz
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Austria
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Innsbruck
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Austria
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Linz
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Austria
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Antwerpen
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Belgium
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Brugge
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Belgium
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Charleroi
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Belgium
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Diepenbeek
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Belgium
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Leuven
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Belgium
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Lommel
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Belgium
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Sijsele-Damme
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Belgium
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Woluwe
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Belgium
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City
Banja Luka
State/Province
Republic of Srpksa
Country
Bosnia and Herzegovina
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Burnaby
State/Province
British Columbia
Country
Canada
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Halifax
State/Province
Nova Scotia
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Canada
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Ottawa
State/Province
Ontario
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Canada
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Levis
State/Province
Quebec
Country
Canada
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City
Quebec City
State/Province
Quebec
Country
Canada
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City
Regina
State/Province
Saskatchewan
Country
Canada
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Montreal
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Canada
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Zagreb
Country
Croatia
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Brno
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Czech Republic
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Jihlava
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Czech Republic
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Opava
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Czech Republic
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Ostrava
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Czech Republic
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Plzen
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Czech Republic
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Praha
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Czech Republic
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Teplice
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Czech Republic
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Clermont Ferrand
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France
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Nice
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France
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Paris
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France
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Rennes
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France
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Bad Neustadt-Saale
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Dusseldorf
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Germany
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Essen
Country
Germany
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Gieben
Country
Germany
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City
Halle
Country
Germany
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Hamburg
Country
Germany
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Hannover
Country
Germany
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Leipzig
Country
Germany
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Minden
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Germany
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Munchen
Country
Germany
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Munster
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Germany
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Osnabruck
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Germany
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Westerstede
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Germany
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Athens
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Greece
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Ioannina
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Greece
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Thessaloniki
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Greece
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Guatemala City
Country
Guatemala
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Chenna
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India
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Coimbatore
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India
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Delhi
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India
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Hyderabad
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India
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Kolkata
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India
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Lucknow
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India
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Mangalore
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India
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Mumbai
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India
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New Delhi
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India
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Pune
Country
India
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Ashkelon
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Israel
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Beer Yaakov
Country
Israel
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Jerusalem
Country
Israel
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Tel Hashomer
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Israel
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Roma
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Italy
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Skopje
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Macedonia, The Former Yugoslav Republic of
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Guadalajara
Country
Mexico
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Mexico City
Country
Mexico
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San Luis Potosi
Country
Mexico
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Chisinau
Country
Moldova, Republic of
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Kishinev
Country
Moldova, Republic of
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Breda
Country
Netherlands
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Sittard
Country
Netherlands
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Christchurch
Country
New Zealand
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Grafton
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New Zealand
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Hamilton
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New Zealand
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Bialystok
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Poland
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Gdansk
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Poland
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Katowice
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Poland
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Krakow
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Poland
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Poznan
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Poland
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Szczecin
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Poland
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Warsaw
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Poland
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Bucuresti
Country
Romania
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Cluj-Napoca
Country
Romania
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Timisoara
Country
Romania
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Belgrade
Country
Serbia
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Kragujevac
Country
Serbia
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Nis
Country
Serbia
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City
Novi Sad
Country
Serbia
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City
Bratislava
Country
Slovakia
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City
Kosice
Country
Slovakia
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City
Martin
Country
Slovakia
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City
Cape Town
Country
South Africa
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City
Durban
Country
South Africa
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Rosebank
Country
South Africa
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Basel
Country
Switzerland
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St. Gallen
Country
Switzerland
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City
Zurich
Country
Switzerland
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City
Kharkiv
Country
Ukraine
Facility Name
Research Site
City
Kyiv
Country
Ukraine
Facility Name
Research Site
City
Lviv
Country
Ukraine
Facility Name
Research Site
City
Odessa
Country
Ukraine
Facility Name
Research Site
City
Poltava
Country
Ukraine
Facility Name
Research Site
City
Zaporozhye
Country
Ukraine
Facility Name
Research Site
City
London
Country
United Kingdom
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Research Site
City
Newcastle
Country
United Kingdom
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Research Site
City
Oxford
Country
United Kingdom
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City
Sheffield
Country
United Kingdom
Facility Name
Research Site
City
Staffordshire
Country
United Kingdom
Facility Name
Research Site
City
Vienna
Country
Virgin Islands (U.S.)
12. IPD Sharing Statement
Citations:
PubMed Identifier
32426039
Citation
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. Erratum In: Ther Adv Neurol Disord. 2020 Oct 21;13:1756286420968357.
Results Reference
derived
PubMed Identifier
30918100
Citation
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.
Results Reference
derived
PubMed Identifier
28770420
Citation
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.
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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.
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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.
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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.
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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.
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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.
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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. Erratum In: Clin Ther. 2018 Mar 7;:
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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.
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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. Erratum In: N Engl J Med. 2012 Dec 13;367(24):2362.
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Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis
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