Multiple Sclerosis Clinical Trial
Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).
Summary
The primary objective of the study is to evaluate the effect of BG00012 on lymphocyte subset counts during the first year of treatment in subjects with relapsing-remitting multiple sclerosis (RRMS). A secondary objective is to evaluate the pharmacodynamic effect on absolute lymphocyte counts (ALCs) and immunoglobulins (Igs) during the first year of treatment.
Eligibility Criteria
Key Inclusion Criteria:
Subjects of childbearing potential (including female subjects who are post-menopausal for less than 1 year) must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
Must have a confirmed diagnosis of RRMS according to the revised McDonald criteria (2010) [Polman 2011]
Key Exclusion Criteria:
History of or positive test result at Screening for:
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
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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There are 31 Locations for this study
Gilbert Arizona, 85234, United States
Long Beach California, 90806, United States
Ocala Florida, 34471, United States
Oldsmar Florida, 34677, United States
Tampa Florida, 33609, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30342, United States
Overland Park Kansas, 66212, United States
Baltimore Maryland, 33612, United States
Traverse City Michigan, 49684, United States
Raleigh North Carolina, 27607, United States
Spartanburg South Carolina, 29307, United States
San Antonio Texas, 78258, United States
Salt Lake City Utah, 84103, United States
Tacoma Washington, 98405, United States
La Louviere Hainaut, 7100, Belgium
Brugge West-Vlaanderen, 8000, Belgium
Brasschaat , 2930, Belgium
Plaven , 5800, Bulgaria
Pleven , 5800, Bulgaria
Sofia , 1113, Bulgaria
Sofia , 1606, Bulgaria
Sofia , , Bulgaria
Kuwait City , 00001, Kuwait
Kaunas , LT-50, Lithuania
Klaipeda , 92288, Lithuania
Vilnius , LT-08, Lithuania
Bydgoszcz , 85-79, Poland
Katowice , 40-59, Poland
Katowice , 40-65, Poland
Lodz , 90-32, Poland
Plewiska , 62-06, Poland
Szczecin , 70-21, Poland
Umuttepe Kocaeli, 41380, Turkey
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