BG00012 Phase 2 Combination Study in Participants With Multiple Sclerosis
NCT ID: NCT01156311
Last Updated: 2017-03-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
108 participants
INTERVENTIONAL
2010-06-30
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Glatiramer acetate (GA) and dimethyl fumarate
Participants taking a stable dose of GA for at least 12 months prior to the study remain on that dose throughout the study. Dimethyl fumarate is administered at 120 mg three times a day (TID) on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
dimethyl fumarate
Days 1-7: 120 mg three times a day (TID) for a total daily dose of 360 mg. Day 8 to Week 24: 240 mg TID for a total daily dose of 720 mg. Drug supplied as a capsule taken orally.
Interferon beta (IFNβ) and dimethyl fumarate
Participants taking a stable dose of one of the IFNβ products for at least 12 months prior to the study remain on that product and dose throughout the study. Dimethyl fumarate is administered at 120 mg three times a day (TID) on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
dimethyl fumarate
Days 1-7: 120 mg three times a day (TID) for a total daily dose of 360 mg. Day 8 to Week 24: 240 mg TID for a total daily dose of 720 mg. Drug supplied as a capsule taken orally.
Interventions
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dimethyl fumarate
Days 1-7: 120 mg three times a day (TID) for a total daily dose of 360 mg. Day 8 to Week 24: 240 mg TID for a total daily dose of 720 mg. Drug supplied as a capsule taken orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have an Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive.
* Must be taking the same dose of a prescribed IFNβ (either Avonex, Betaseron, Rebif) or GA for at least 12 months consecutively at the time of enrollment and remain on this treatment for the duration of the study. Participants receiving Rebif must be prescribed 44 μg by subcutaneous injection three times per week.
Exclusion Criteria
* Other chronic disease of the immune system, malignancies, acute urologic, or pulmonary disease.
* Pregnant or nursing women.
* Participation within 6 months prior to study enrollment in any other drug, biologic, or device study.
18 Years
55 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Research Site
Gilbert, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Danbury, Connecticut, United States
Research Site
Atlanta, Georgia, United States
Research Site
Fort Wayne, Indiana, United States
Research Site
Baltimore, Maryland, United States
Research Site
Boston, Massachusetts, United States
Research Site
Golden Valley, Minnesota, United States
Research Site
Teaneck, New Jersey, United States
Research Site
Patchogue, New York, United States
Research Site
Cleveland, Ohio, United States
Research Site
Dayton, Ohio, United States
Research Site
Portland, Oregon, United States
Research Site
Cordova, Tennessee, United States
Research Site
Franklin, Tennessee, United States
Research Site
Milwaukee, Wisconsin, United States
Countries
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References
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Calkwood J, Vollmer T, Fox RJ, Zhang R, Novas M, Sheikh SI, Viglietta V. Safety and Tolerability of Delayed-Release Dimethyl Fumarate Administered with Interferon Beta or Glatiramer Acetate in Relapsing-Remitting Multiple Sclerosis. Int J MS Care. 2016 May-Jun;18(3):138-46. doi: 10.7224/1537-2073.2015-020.
Other Identifiers
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109MS201
Identifier Type: -
Identifier Source: org_study_id
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