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

Primary Purpose

Relapsing-Remitting Multiple Sclerosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BG00012
Placebo
Glatiramer Acetate
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing-Remitting Multiple Sclerosis focused on measuring relapsing, multiple sclerosis, oral, remitting

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

BG00012 240 mg Twice Daily (BID)

BG00012 240 mg 3 Times Daily (TID)

Placebo

Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)

Arm Description

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)

Participants received two placebo capsules orally three times daily (TID)

Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)

Outcomes

Primary Outcome Measures

Annualized Relapse Rate
A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee. The adjusted annualized relapse rate was calculated from a negative binomial regression model , adjusted for baseline Expanded Disability Status Scale (EDSS ) score(≤2.0 versus>2.0), age (<40 versus ≥40 years), region, and the number of relapses in the 1 year prior to enrollment.

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 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
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
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)
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

Full Information

First Posted
March 21, 2007
Last Updated
January 13, 2015
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT00451451
Brief Title
Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis
Acronym
CONFIRM
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 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. 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.
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.

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, multiple sclerosis, oral, remitting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1417 (Actual)

8. Arms, Groups, and Interventions

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)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received two placebo capsules orally three times daily (TID)
Arm Title
Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)
Arm Type
Active Comparator
Arm Description
Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
Intervention Type
Drug
Intervention Name(s)
BG00012
Other Intervention Name(s)
dimethyl fumarate, Tecfidera®
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Glatiramer Acetate
Primary Outcome Measure Information:
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 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.
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 hyperintense lesion count were calculated from a negative binomial regression model adjusted for region and baseline T2 hyperintense lesion volume.
Time Frame
2 years
Title
Number of New T1 Hypointense Lesions
Description
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.
Time Frame
2 years
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 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.
Time Frame
2 years
Title
Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS)
Description
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
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
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Birmingham
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Alabama
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United States
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Cullman
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Huntsville
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Sacramento
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Colorado Springs
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Miami
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Columbus
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Grand Rapids
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Buffalo
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Mineola
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Patchogue
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Plainview
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Stony Brook
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Cleveland
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Columbus
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Medford
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Portland
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Souderton
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Cordova
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Franklin
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Knoxville
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Memphis
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Nashville
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Dallas
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Galveston
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Houston
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Round Rock
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Gomel
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Belarus
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Minsk
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Belarus
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Vitebsk
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Belarus
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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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Tuzla
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B&H Federation
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Bosnia and Herzegovina
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Banja Luka
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Republic Srpska
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Bosnia and Herzegovina
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Sarajevo B&H Federation
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Bosnia and Herzegovina
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Plovdiv
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Bulgaria
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Rousse
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Bulgaria
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Sofia
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Bulgaria
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Stara Zagora
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Bulgaria
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Varna
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Bulgaria
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Edmonton
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Canada
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London
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Canada
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Montreal
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Canada
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Osijek
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Canada
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San Jose
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Costa Rica
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Rijeka
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Croatia
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Zagreb
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Croatia
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Ostrava-Moravska
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Czech Republic
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Ostrava
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Czech Republic
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Praha
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Czech Republic
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Kuressaare
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Estonia
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Parnu
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Estonia
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Tallinn
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Estonia
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Tartu
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Estonia
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Caen
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France
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Dijon
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France
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Marseille
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France
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Montpellier
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France
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Nancy
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France
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Nimes
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France
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Strasbourg
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France
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Bamberg
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Germany
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Bayreuth
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Germany
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Berg Starnberger
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Germany
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Berlin
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Germany
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Dusseldorf
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Germany
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Erbach
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Germany
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Erlangen
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Germany
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Giessen
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Germany
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Halle (Saale)
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Germany
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Hanburg
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Germany
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Heidelberg
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Germany
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Koln
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Germany
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Magdeburg
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Germany
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Marburg
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Germany
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Munchen
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Germany
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Regensburg
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Germany
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Schwerin
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Germany
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Athens
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Greece
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Larisa
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Greece
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Patra
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Greece
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Thessaloniki
Country
Greece
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Ahmedabad
Country
India
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Bangalore
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India
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Calicut
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India
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Chandigarh
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India
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Chennai
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India
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Cochin
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India
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Coimbatore
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India
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Kochi
Country
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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Ludhiana
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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
Facility Name
Research Site
City
Pune
Country
India
Facility Name
Research Site
City
Cork
Country
Ireland
Facility Name
Research Site
City
Dublin
Country
Ireland
Facility Name
Research Site
City
Galway
Country
Ireland
Facility Name
Research Site
City
Holon
Country
Israel
Facility Name
Research Site
City
Safed
Country
Israel
Facility Name
Research Site
City
Riga
Country
Latvia
Facility Name
Research Site
City
Skopje
Country
Macedonia, The Former Yugoslav Republic of
Facility Name
Research Site
City
Guadalajara
State/Province
Jal
Country
Mexico
Facility Name
Research Site
City
Morelia
State/Province
Michoacan
Country
Mexico
Facility Name
Research Site
City
Monterrey
State/Province
Nuevo Leon
Country
Mexico
Facility Name
Research Site
City
Aguascalientes
Country
Mexico
Facility Name
Research Site
City
Guadalajara
Country
Mexico
Facility Name
Research Site
City
Mexico DF
ZIP/Postal Code
10700
Country
Mexico
Facility Name
Research Site
City
Mexico DF
Country
Mexico
Facility Name
Research Site
City
Mexico
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Research Site
City
Monterray
Country
Mexico
Facility Name
Research Site
City
Chisinau
Country
Moldova, Republic of
Facility Name
Research Site
City
Kishinev
Country
Moldova, Republic of
Facility Name
Research Site
City
Hamilton
Country
New Zealand
Facility Name
Research Site
City
Bialystok
Country
Poland
Facility Name
Research Site
City
Gdansk
Country
Poland
Facility Name
Research Site
City
Katowice
Country
Poland
Facility Name
Research Site
City
Lodz
Country
Poland
Facility Name
Research Site
City
Lublin
Country
Poland
Facility Name
Research Site
City
Poznan
Country
Poland
Facility Name
Research Site
City
Szczecin
Country
Poland
Facility Name
Research Site
City
Warsaw
Country
Poland
Facility Name
Research Site
City
Warszawa
Country
Poland
Facility Name
Research Site
City
Wroclaw
Country
Poland
Facility Name
Research Site
City
Guaynabo
Country
Puerto Rico
Facility Name
Research Site
City
Bucuresti
Country
Romania
Facility Name
Research Site
City
Iasi
Country
Romania
Facility Name
Research Site
City
Oradea
Country
Romania
Facility Name
Research Site
City
Tirgu Mures
Country
Romania
Facility Name
Research Site
City
Tirgu-Mures
Country
Romania
Facility Name
Research Site
City
Belgrade
Country
Serbia
Facility Name
Research Site
City
Kragujevac
Country
Serbia
Facility Name
Research Site
City
Nis
Country
Serbia
Facility Name
Research Site
City
Novi Sad
Country
Serbia
Facility Name
Research Site
City
Kosice
Country
Slovakia
Facility Name
Research Site
City
Martin
Country
Slovakia
Facility Name
Research Site
City
Barcelona
Country
Spain
Facility Name
Research Site
City
Bilbao
Country
Spain
Facility Name
Research Site
City
Cordoba
Country
Spain
Facility Name
Research Site
City
Gandia
Country
Spain
Facility Name
Research Site
City
Madrid
Country
Spain
Facility Name
Research Site
City
Malaga
Country
Spain
Facility Name
Research Site
City
Santiago de Compostela
Country
Spain
Facility Name
Research Site
City
Sevilla
Country
Spain
Facility Name
Research Site
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
Simferopol
Country
Ukraine
Facility Name
Research Site
City
Zaporozhye
Country
Ukraine

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.
Results Reference
derived
PubMed Identifier
28751099
Citation
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.
Results Reference
derived
PubMed Identifier
27733070
Citation
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.
Results Reference
derived
PubMed Identifier
26932146
Citation
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.
Results Reference
derived
PubMed Identifier
26526385
Citation
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.
Results Reference
derived
PubMed Identifier
24131282
Citation
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.
Results Reference
derived
PubMed Identifier
22992072
Citation
Fox RJ, Miller DH, Phillips JT, Hutchinson M, Havrdova E, Kita M, Yang M, Raghupathi K, Novas M, Sweetser MT, Viglietta V, Dawson KT; CONFIRM Study Investigators. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med. 2012 Sep 20;367(12):1087-97. doi: 10.1056/NEJMoa1206328. Erratum In: N Engl J Med. 2012 Oct 25;367(17):1673.
Results Reference
derived

Learn more about this trial

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

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