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 |
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.
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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