EUCTR2015-001973-42-HRActive, not recruitingPhase 1
An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Biogen Idec Research Limited
- Enrollment
- 218
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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
Investigators
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