Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).
NCT ID: NCT02525874
Last Updated: 2019-06-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
218 participants
INTERVENTIONAL
2015-08-11
2018-04-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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dimethyl fumarate
120 mg twice daily (BID) for the first 7 days and 240 mg BID thereafter
dimethyl fumarate
Initial oral dose for 7 days with maintenance dose thereafter
Interventions
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dimethyl fumarate
Initial oral dose for 7 days with maintenance dose thereafter
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have a confirmed diagnosis of RRMS according to the revised McDonald criteria (2010) \[Polman 2011\]
Exclusion Criteria
* human immunodeficiency virus
* hepatitis C virus antibody
* hepatitis B infection
* Drug or alcohol abuse within 1 year prior to Screening.
* Prior treatment with any of the following:
* cladribine
* mitoxantrone
* total lymphoid irradiation
* alemtuzumab
* T-cell or T-cell receptor vaccination
* any therapeutic monoclonal antibody, with the exception of natalizumab or daclizumab
* Treatment with any of the following medications or procedures within 6 months prior to Baseline (Day 1):
* DMF (given as Fumaderm®) or BG00012; enrollment will be limited to no more than 40 subjects (out of 200) with prior DMF exposure
* cyclosporine
* azathioprine
* methotrexate
* mycophenolate mofetil
* intravenous (IV) Ig
* plasmapheresis or cytapheresis
18 Years
65 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
Long Beach, California, United States
Research Site
Ocala, Florida, United States
Research Site
Oldsmar, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Overland Park, Kansas, United States
Research Site
Baltimore, Maryland, United States
Research Site
Traverse City, Michigan, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Spartanburg, South Carolina, United States
Research Site
San Antonio, Texas, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Tacoma, Washington, United States
Research Site
La Louvière, Hainaut, Belgium
Research Site
Bruges, West-Vlaanderen, Belgium
Research Site
Brasschaat, , Belgium
Research Site
Plaven, , Bulgaria
Research Site
Pleven, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Kuwait City, , Kuwait
Research Site
Kaunas, , Lithuania
Research Site
Klaipėda, , Lithuania
Research Site
Vilnius, , Lithuania
Research Site
Bydgoszcz, , Poland
Research Site
Katowice, , Poland
Research Site
Katowice, , Poland
Research Site
Lodz, , Poland
Research Site
Plewiska, , Poland
Research Site
Szczecin, , Poland
Research Site
Umuttepe, Kocaeli, Turkey (Türkiye)
Countries
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References
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Mao-Draayer Y, Bar-Or A, Balashov K, Foley J, Smoot K, Longbrake EE, Robertson D, Mendoza JP, Lewin JB, Everage N, Bozin I, Lyons J, Mokliatchouk O, Bame E, Giuliani F. Real-World Safety and Effectiveness of Dimethyl Fumarate in Patients with MS: Results from the ESTEEM Phase 4 and PROCLAIM Phase 3 Studies with a Focus on Older Patients. Adv Ther. 2025 Jan;42(1):395-412. doi: 10.1007/s12325-024-03047-w. Epub 2024 Nov 21.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-001973-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
109MS310
Identifier Type: -
Identifier Source: org_study_id
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