Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).



Status:Completed
Conditions:Neurology, Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - 65
Updated:11/22/2018
Start Date:August 31, 2015
End Date:April 23, 2018

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An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis

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.


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
We found this trial at
15
sites
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Ocala, FL
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La Louviere,
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Long Beach, CA
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Oldsmar, FL
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Overland Park, KS
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Raleigh, NC
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San Antonio, TX
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Spartanburg, South Carolina 29303
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Tacoma, WA
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Traverse City, MI
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