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

• Status: Completed
• Trial end date: 2018-04-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen
• Treatments: Dimethyl Fumarate

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