A Phase 4 Multicenter, Open-Label, Single Arm study to evaluate switching from BRACET/Gilenya to Natalizumab in subjects with relapsing forms of Multiple Sclerosis(MS).
The purpose of this study is to assess the proportion of subjects who attain no evidence of disease activity (NEDA) on Tysabri (natalizumab) after they have experienced activity of disease clinically or radiologically while on BRACET (Betaseron, Rebif, Avonex, Copaxone, Extavia, Tecfidera) or Gilenya therapy. This would provide evidence of the efficacy and safety of Tysabri in subjects who have relapsed while receiving Gilenya or BRACET, and provide rationale for use of Tysabri for efficacy-based switching from Gilenya or BRACET.
Neuroscience - Multiple Sclerosis,
Pavle Repovic, MD, PhD
Key Inclusion Criteria:
- Subjects of childbearing potential must practice effective contraception from Day -1 and be willing and able to continue contraception for duration of the study.
- Must have documented diagnosis of relapsing MS (McDonald 2010 Criteria [Polman 2011]) at Screening.
- Must have been treated with Gilenya or BRACET for at least the 12 months prior to Screening with no interruption of treatment greater than 1 month. More than 1 prior disease-modifying therapy is allowed, as long as minimum treatment duration was cumulatively 12 months. Prior treatment with natalizumab is allowed; however, there must be a minimum 1 year since last natalizumab infusion and the Screening visit of this study, and if discontinuation of natalizumab in the past was not due to intolerance, anti-natalizumab antibodies, or efficacy loss.
- Must have had disease activity in the 6 months prior to Screening while on Gilenya or BRACET (as de...