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BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE)

Primary Purpose

Relapsing-Remitting Multiple Sclerosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
dimethyl fumarate
Placebo
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, remitting, oral

Eligibility Criteria

19 Years - 58 Years (Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

-Subjects who participated in and completed as per protocol previous BG00012 clinical studies 109MS301 (NCT00420212) or 109MS302 (NCT00451451).

Key Exclusion Criteria:

  • Any significant change in medical history from 109MS301 or 109MS302 that would have excluded subject's participation from their previous study.
  • Subjects from 109MS301 or 109MS302 who discontinued oral study treatment due to an AE or due to reasons other than protocol-defined relapse/disability progression.
  • Subjects from 109MS301 or 109MS302 who discontinued study treatment due to disability progression or relapses and did not follow the modified visit schedule up to Week 96.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

BG00012 plus placebo

BG00012

Arm Description

In the first phase, participants will receive BG00012 240 mg (two 120 mg capsules) twice a day (BID) and 2 placebo capsules once a day. In the second phase participants will receive open-label BG00012 240 mg BID, for atleast 8 years.

In the first phase participants will receive BG00012 240 mg (two 120 mg capsules) three times a day (TID). In the second phase participants will receive open-label BG00012 240 mg BID for atleast 8 years.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events (AEs)
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

Secondary Outcome Measures

Percentage of Participants Who Had Relapses
Relapses were defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours.
Annualized Relapse Rate (ARR)
The annualized relapse rate is calculated as the total number of relapses occurred during the period for all participants, divided by the total number of participant-years followed in the period.
Change From Baseline in the Expanded Disability Status Scale (EDSS) at Week 384
EDSS scale ranges from 0 (Normal neurological exam, no disability) to 10 (Death) in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. Sustained disability progression was defined as at least a 1.0 point increase on the EDSS from a baseline EDSS ≥1.0 that was sustained for at least 24 weeks, or a 1.5 point increase on the EDSS from a baseline EDSS =0 that was sustained for at least 24 weeks.
Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI)
The Gd-enhancing lesions was evaluated using MRI technique.
Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI)
The Gd-enhancing lesions was evaluated using MRI technique.
Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI)
The T2 lesions was evaluated using MRI technique.
Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI)
The T2 lesions was evaluated using MRI technique.
Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI)
The T1 hypointense lesions was evaluated using MRI technique.
Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI)
The T1 hypointense lesions was evaluated using MRI technique.
Percent Change From Baseline in Brain Atrophy
Brain atrophy was measured using magnetic resonance imaging (MRI) technique.
Percent Change From Baseline in Magnetization Transfer Ratio (MTR)
Magnetization Transfer Ratio (MTR) was measured using MRI technique.
Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384
The SF-36 is a brief (36-item) scale reflecting the impact of both dysfunctions and general health perception the questionnaire measures: 1.physical function (PF),2. role physical (RF),3. bodily pain (BP),4. role emotional (RE),5. social function (SF), 6. general health (GH),7. vitality (VT), 8. mental health (MH). Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of the SF-36. The questions related to each dimension are scored on a scale from 0 (worst score) to 100 (best score), with higher scores indicating better function.
Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - EQ-5D Index Score at Week 384
The EQ-5D is a generic health-related quality of life instrument consisting of 2 components, EQ-5D index score and EQ-VAS. The EQ-5D provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has (1) "no problems", (2) "some problems", or (3) "severe problems". A positive change from baseline indicates improvement.
Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - Visual Analog Scale (VAS) at Week 384
The EQ-5D is a generic health-related quality of life instrument consisting of 2 components, EQ-5D index score and EQ-VAS. In EQ-VAS participants are asked to rate their current health on a 20 centimeter (cm) scale from 0 to 100 where 0 represents "worst imaginable health state" and 100 represents "best imaginable health state". A positive change from baseline indicates improvement.
Change From Baseline in Visual Function Test Scores at Week 384
Participants were tested using the contrast level of 100%, 2.5%, and 1.25% charts, and the scores were defined as the number of letters identified correctly for each chart (the maximum score was 60). Higher scores indicate better functioning. A positive change from baseline indicates better functioning.

Full Information

First Posted
February 2, 2009
Last Updated
December 7, 2020
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT00835770
Brief Title
BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)
Acronym
ENDORSE
Official Title
A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects With Relapsing-Remitting Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
February 3, 2009 (Actual)
Primary Completion Date
November 8, 2019 (Actual)
Study Completion Date
November 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test.
Detailed Description
The initial BG00012 dosage for the extension study (240 mg BID or 240 mg TID) was the same as that used in the Phase 3 Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451). Subsequent to the initiation of this study, BG00012 was approved in several countries for the treatment of MS at a dose of 240 mg BID. For this reason, all participants continuing in this study will receive the currently marketed dose of 240 mg BID.

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, remitting, oral

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1736 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BG00012 plus placebo
Arm Type
Experimental
Arm Description
In the first phase, participants will receive BG00012 240 mg (two 120 mg capsules) twice a day (BID) and 2 placebo capsules once a day. In the second phase participants will receive open-label BG00012 240 mg BID, for atleast 8 years.
Arm Title
BG00012
Arm Type
Experimental
Arm Description
In the first phase participants will receive BG00012 240 mg (two 120 mg capsules) three times a day (TID). In the second phase participants will receive open-label BG00012 240 mg BID for atleast 8 years.
Intervention Type
Drug
Intervention Name(s)
dimethyl fumarate
Other Intervention Name(s)
BG00012, Tecfidera, DMF
Intervention Description
BG00012 capsules
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsules taken to maintain the blind in the 240 mg BID treatment group.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs)
Description
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time Frame
Day 1 up to Week 561
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Had Relapses
Description
Relapses were defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours.
Time Frame
Day 1 up to Week 384
Title
Annualized Relapse Rate (ARR)
Description
The annualized relapse rate is calculated as the total number of relapses occurred during the period for all participants, divided by the total number of participant-years followed in the period.
Time Frame
Day 1 up to Week 384
Title
Change From Baseline in the Expanded Disability Status Scale (EDSS) at Week 384
Description
EDSS scale ranges from 0 (Normal neurological exam, no disability) to 10 (Death) in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. Sustained disability progression was defined as at least a 1.0 point increase on the EDSS from a baseline EDSS ≥1.0 that was sustained for at least 24 weeks, or a 1.5 point increase on the EDSS from a baseline EDSS =0 that was sustained for at least 24 weeks.
Time Frame
Baseline, Week 384
Title
Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI)
Description
The Gd-enhancing lesions was evaluated using MRI technique.
Time Frame
Baseline up to Week 288
Title
Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI)
Description
The Gd-enhancing lesions was evaluated using MRI technique.
Time Frame
Baseline up to Week 288
Title
Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI)
Description
The T2 lesions was evaluated using MRI technique.
Time Frame
Baseline up to Week 288
Title
Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI)
Description
The T2 lesions was evaluated using MRI technique.
Time Frame
Baseline up to Week 288
Title
Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI)
Description
The T1 hypointense lesions was evaluated using MRI technique.
Time Frame
Baseline up to Week 288
Title
Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI)
Description
The T1 hypointense lesions was evaluated using MRI technique.
Time Frame
Baseline up to Week 288
Title
Percent Change From Baseline in Brain Atrophy
Description
Brain atrophy was measured using magnetic resonance imaging (MRI) technique.
Time Frame
Baseline up to Week 288
Title
Percent Change From Baseline in Magnetization Transfer Ratio (MTR)
Description
Magnetization Transfer Ratio (MTR) was measured using MRI technique.
Time Frame
Baseline up to Week 288
Title
Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384
Description
The SF-36 is a brief (36-item) scale reflecting the impact of both dysfunctions and general health perception the questionnaire measures: 1.physical function (PF),2. role physical (RF),3. bodily pain (BP),4. role emotional (RE),5. social function (SF), 6. general health (GH),7. vitality (VT), 8. mental health (MH). Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of the SF-36. The questions related to each dimension are scored on a scale from 0 (worst score) to 100 (best score), with higher scores indicating better function.
Time Frame
Baseline, Week 384
Title
Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - EQ-5D Index Score at Week 384
Description
The EQ-5D is a generic health-related quality of life instrument consisting of 2 components, EQ-5D index score and EQ-VAS. The EQ-5D provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has (1) "no problems", (2) "some problems", or (3) "severe problems". A positive change from baseline indicates improvement.
Time Frame
Baseline, Week 384
Title
Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - Visual Analog Scale (VAS) at Week 384
Description
The EQ-5D is a generic health-related quality of life instrument consisting of 2 components, EQ-5D index score and EQ-VAS. In EQ-VAS participants are asked to rate their current health on a 20 centimeter (cm) scale from 0 to 100 where 0 represents "worst imaginable health state" and 100 represents "best imaginable health state". A positive change from baseline indicates improvement.
Time Frame
Baseline, Week 384
Title
Change From Baseline in Visual Function Test Scores at Week 384
Description
Participants were tested using the contrast level of 100%, 2.5%, and 1.25% charts, and the scores were defined as the number of letters identified correctly for each chart (the maximum score was 60). Higher scores indicate better functioning. A positive change from baseline indicates better functioning.
Time Frame
Baseline, Week 384

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
58 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: -Subjects who participated in and completed as per protocol previous BG00012 clinical studies 109MS301 (NCT00420212) or 109MS302 (NCT00451451). Key Exclusion Criteria: Any significant change in medical history from 109MS301 or 109MS302 that would have excluded subject's participation from their previous study. Subjects from 109MS301 or 109MS302 who discontinued oral study treatment due to an AE or due to reasons other than protocol-defined relapse/disability progression. Subjects from 109MS301 or 109MS302 who discontinued study treatment due to disability progression or relapses and did not follow the modified visit schedule up to Week 96. 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
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Research Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
research Site
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Research Site
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Research Site
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Research Site
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Research Site
City
North Haven
State/Province
Connecticut
ZIP/Postal Code
06473
Country
United States
Facility Name
Research Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Research Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Research Site
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Research Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30327
Country
United States
Facility Name
Research Site
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Research Site
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
Research Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Research Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67206
Country
United States
Facility Name
Research Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Research Site
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Research Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
Facility Name
Research Site
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Research Site
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Research Site
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Research Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Research Site
City
Patchogue
State/Province
New York
ZIP/Postal Code
11772
Country
United States
Facility Name
Research Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Research Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Research Site
City
Bellevue
State/Province
Ohio
ZIP/Postal Code
44811
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Research Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Research Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Research Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Research Site
City
Rumford
State/Province
Rhode Island
ZIP/Postal Code
02916
Country
United States
Facility Name
Research Site
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
Research Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Research Site
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23601
Country
United States
Facility Name
Research Site
City
Issaquah
State/Province
Washington
ZIP/Postal Code
98029
Country
United States
Facility Name
Research Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Research Site
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Research Site
City
New Lambton Heights
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Research Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Research Site
City
Box Hill
ZIP/Postal Code
3128
Country
Australia
Facility Name
Research Site
City
Chatswood
ZIP/Postal Code
2067
Country
Australia
Facility Name
Research Site
City
Fitzroy
ZIP/Postal Code
3065
Country
Australia
Facility Name
Research Site
City
Geelong
ZIP/Postal Code
3220
Country
Australia
Facility Name
Research Site
City
Sydney
ZIP/Postal Code
2000
Country
Australia
Facility Name
Research Site
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Research Site
City
Linz
ZIP/Postal Code
4021
Country
Austria
Facility Name
Research Site
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Research Site
City
Belarus
State/Province
Gomel
ZIP/Postal Code
246029
Country
Belarus
Facility Name
Research Site
City
Belarus
State/Province
Vitebsk
ZIP/Postal Code
210023
Country
Belarus
Facility Name
Research Site
City
Minsk
ZIP/Postal Code
220114
Country
Belarus
Facility Name
Research Site
City
Minsk
ZIP/Postal Code
220116
Country
Belarus
Facility Name
Research Site
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Research Site
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Research Site
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Research Site
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Research Site
City
Damme
ZIP/Postal Code
8340
Country
Belgium
Facility Name
Research Site
City
Diepenbeek
ZIP/Postal Code
3590
Country
Belgium
Facility Name
Research Site
City
Hechtel-Eksel
ZIP/Postal Code
3940
Country
Belgium
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Research Site
City
Lodelinsart
ZIP/Postal Code
6042
Country
Belgium
Facility Name
Research Site
City
Sint-Truiden
ZIP/Postal Code
3800
Country
Belgium
Facility Name
Research Site
City
Tuzla
ZIP/Postal Code
75000
Country
Bosnia and Herzegovina
Facility Name
Research Site
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Research Site
City
Lévis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada
Facility Name
Research Site
City
Edmonton
ZIP/Postal Code
T6G 2G3
Country
Canada
Facility Name
Research Site
City
London
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Research Site
City
Montreal
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
Research Site
City
Nova Scotia
ZIP/Postal Code
B3H 4K4
Country
Canada
Facility Name
Research Site
City
Ottawa
ZIP/Postal Code
K2G 6E2
Country
Canada
Facility Name
Research Site
City
Regina
ZIP/Postal Code
S4T 7T1
Country
Canada
Facility Name
Research Site
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Research Site
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Research Site
City
Jihlava
ZIP/Postal Code
586 33
Country
Czechia
Facility Name
Research Site
City
Moravska Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
Research Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Research Site
City
Opava
ZIP/Postal Code
746 01
Country
Czechia
Facility Name
Research Site
City
Ostrava - Vítkovice
ZIP/Postal Code
70300
Country
Czechia
Facility Name
Research Site
City
Prague
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Research Site
City
Prague
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Research Site
City
Teplice
ZIP/Postal Code
415 01
Country
Czechia
Facility Name
Research Site
City
Parnu
ZIP/Postal Code
80010
Country
Estonia
Facility Name
Research Site
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
Research Site
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Research Site
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Research Site
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Research Site
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Research Site
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Research Site
City
Dijon
ZIP/Postal Code
21033
Country
France
Facility Name
Research Site
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Research Site
City
Lyon
ZIP/Postal Code
69394
Country
France
Facility Name
Research Site
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Research Site
City
Montpellier
ZIP/Postal Code
34090
Country
France
Facility Name
Research Site
City
Nancy
ZIP/Postal Code
54035
Country
France
Facility Name
Research Site
City
Nice
ZIP/Postal Code
06002
Country
France
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Research Site
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Research Site
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Research Site
City
Berg
State/Province
Bavaria
ZIP/Postal Code
82335
Country
Germany
Facility Name
Research Site
City
Steinfurt
State/Province
Ibbenbueren
ZIP/Postal Code
49477
Country
Germany
Facility Name
Research Site
City
Bayreuth
ZIP/Postal Code
95445
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
10437
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
10625
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
10961
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
12099
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
12163
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
13347
Country
Germany
Facility Name
Research Site
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Research Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Research Site
City
Dusseldorf
ZIP/Postal Code
40212
Country
Germany
Facility Name
Research Site
City
Erbach
ZIP/Postal Code
64711
Country
Germany
Facility Name
Research Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Research Site
City
Essen
ZIP/Postal Code
45257
Country
Germany
Facility Name
Research Site
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Research Site
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Research Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Research Site
City
Hamburg
ZIP/Postal Code
22083
Country
Germany
Facility Name
Research Site
City
Hannover
ZIP/Postal Code
30171
Country
Germany
Facility Name
Research Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Research Site
City
Koeln
ZIP/Postal Code
50935
Country
Germany
Facility Name
Research Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Research Site
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Research Site
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Research Site
City
Minden
ZIP/Postal Code
32429
Country
Germany
Facility Name
Research Site
City
Munich (München)
ZIP/Postal Code
81675
Country
Germany
Facility Name
Research Site
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Research Site
City
Osnabrück
ZIP/Postal Code
49076
Country
Germany
Facility Name
Research Site
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Research Site
City
Westerstede
ZIP/Postal Code
26655
Country
Germany
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Research Site
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Facility Name
Research Site
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
Research Site
City
Ahmedabad
ZIP/Postal Code
380006
Country
India
Facility Name
Research Site
City
Bangalore
ZIP/Postal Code
560054
Country
India
Facility Name
Research Site
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Facility Name
Research Site
City
Hyderabad
ZIP/Postal Code
500082
Country
India
Facility Name
Research Site
City
Kolkata
ZIP/Postal Code
700054
Country
India
Facility Name
Research Site
City
Kolkata
ZIP/Postal Code
700068
Country
India
Facility Name
Research Site
City
Ludhiana
ZIP/Postal Code
141001
Country
India
Facility Name
Research Site
City
Ludhiana
ZIP/Postal Code
141008
Country
India
Facility Name
Research Site
City
Mangalore
ZIP/Postal Code
575002
Country
India
Facility Name
Research Site
City
Mumbai
ZIP/Postal Code
400054
Country
India
Facility Name
Research Site
City
New Delhi
ZIP/Postal Code
110017
Country
India
Facility Name
Research Site
City
New Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Research Site
City
New Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
Research Site
City
Pune
ZIP/Postal Code
411001
Country
India
Facility Name
Research Site
City
Pune
ZIP/Postal Code
411004
Country
India
Facility Name
Research Site
City
Dublin
ZIP/Postal Code
DUBLIN 4
Country
Ireland
Facility Name
Research Site
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Research Site
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Research Site
City
Safed
ZIP/Postal Code
13100
Country
Israel
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
Research Site
City
Riga
ZIP/Postal Code
LV-1015
Country
Latvia
Facility Name
Research Site
City
Guadalajara
ZIP/Postal Code
44610
Country
Mexico
Facility Name
Research Site
City
Mexico
ZIP/Postal Code
03310
Country
Mexico
Facility Name
Research Site
City
Mexico
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Research Site
City
Mexico
ZIP/Postal Code
06720
Country
Mexico
Facility Name
Research Site
City
Morelia
ZIP/Postal Code
58000
Country
Mexico
Facility Name
Research Site
City
San Luis Potosi
ZIP/Postal Code
78240
Country
Mexico
Facility Name
Research Site
City
Chisinau
ZIP/Postal Code
2001
Country
Moldova, Republic of
Facility Name
Research Site
City
Chisinau
ZIP/Postal Code
2028
Country
Moldova, Republic of
Facility Name
Research Site
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Research Site
City
Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
Facility Name
Research Site
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Research Site
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Research Site
City
Hamilton
ZIP/Postal Code
3204
Country
New Zealand
Facility Name
Research Site
City
Skopje
ZIP/Postal Code
1000
Country
North Macedonia
Facility Name
Research Site
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Research Site
City
Bialystok
ZIP/Postal Code
15-402
Country
Poland
Facility Name
Research Site
City
Gdansk
ZIP/Postal Code
80-299
Country
Poland
Facility Name
Research Site
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Facility Name
Research Site
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Research Site
City
Katowice
ZIP/Postal Code
40-594
Country
Poland
Facility Name
Research Site
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
31-505
Country
Poland
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Research Site
City
Lódz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Research Site
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Facility Name
Research Site
City
Plewiska
ZIP/Postal Code
62-064
Country
Poland
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
60-355
Country
Poland
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
60-539
Country
Poland
Facility Name
Research Site
City
Szczecin
ZIP/Postal Code
70-215
Country
Poland
Facility Name
Research Site
City
Szczecin
ZIP/Postal Code
71-252
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-957
Country
Poland
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Research Site
City
Guaynabo
ZIP/Postal Code
00968
Country
Puerto Rico
Facility Name
Research Site
City
Bucuresti
ZIP/Postal Code
011464
Country
Romania
Facility Name
Research Site
City
Bucuresti
ZIP/Postal Code
020125
Country
Romania
Facility Name
Research Site
City
Bucuresti
ZIP/Postal Code
022104
Country
Romania
Facility Name
Research Site
City
Bucuresti
ZIP/Postal Code
050098
Country
Romania
Facility Name
Research Site
City
Cluj-Napoca
ZIP/Postal Code
400012
Country
Romania
Facility Name
Research Site
City
Timisoara
ZIP/Postal Code
300736
Country
Romania
Facility Name
Research Site
City
Târgu Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
Research Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Research Site
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Research Site
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Research Site
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Research Site
City
Bratislava
ZIP/Postal Code
81369
Country
Slovakia
Facility Name
Research Site
City
Bratislava
ZIP/Postal Code
82606
Country
Slovakia
Facility Name
Research Site
City
Martin
ZIP/Postal Code
03659
Country
Slovakia
Facility Name
Research Site
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Research Site
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Research Site
City
Córdoba
ZIP/Postal Code
14011
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Research Site
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Research Site
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Research Site
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Research Site
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Research Site
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Research Site
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Research Site
City
Kharkiv
ZIP/Postal Code
61103
Country
Ukraine
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
03110
Country
Ukraine
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
04112
Country
Ukraine
Facility Name
Research Site
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Research Site
City
Odessa
ZIP/Postal Code
65117
Country
Ukraine
Facility Name
Research Site
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine
Facility Name
Research Site
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine
Facility Name
Research Site
City
Zaporizhzhia
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
Research Site
City
London
ZIP/Postal Code
E1 2EF
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
E1 4AT
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
SE5 9NT
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Research Site
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 4HH
Country
United Kingdom
Facility Name
Research Site
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Research Site
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
Research Site
City
Stoke on Trent
ZIP/Postal Code
ST4 6QG
Country
United Kingdom

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
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

Learn more about this trial

BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)

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