Current Enrolling Clinical Trials

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1 ASSESS RRMS patients with active disease who are still able to walk. Mariko Kita MD Description of Study/Trial: A 12-month, randomized, rater- and dose-blinded study to compare the efficacy and safety of fingolimod 0.25 mg and 0.5 mg administered orally once daily with glatiramer acetate 20 mg administered subcutaneously once daily in patients with relapsing-remitting multiple sclerosis. The purpose of this study is to compare 2 doses (0.25 mg and 0.50 mg) of fingolimod to copaxone (20 mg) and to evaluate the efficacy of fingolimod 0.25 mg for the treatment of patients with relapsingremitting MS (RRMS) as part of a post approval commitment for the FDA. A substudy will be conducted in a few select sites in approximately 24 patients to assess the impact of chronic fingolimod treatment on the proportions of Th17 and Treg cells in the blood of MS patients chronically treated with fingolimod as part of a follow-up measure for the CHMP of the European Medicines Agency.

2 PREFER RRMS patients who are still able to walk who have fairly little treatment exposure to standard DMTs. Mariko Kita MD Description of Study/Trial: A 12-month, Prospective, Randomized, active-controlled, open-label study to Evaluate patient retention of Fingolimod vs. approved first-line disease modifying therapies in adults with Relapsing remitting Multiple Sclerosis. (PREFERMS)The purpose of this study is to evaluate the effectiveness of fingolimod 0.5 mg/day versus approved first line disease modifying therapies (DMT) as measured by patient retention on randomized treatment over 12 months. The study will include adult patients with relapsing remitting MS. For the purpose of this study, patients may be either treatment naive or may have been treated with no more than one class of approved first line DMT (interferon β preparation or glatiramer acetate).

3 BAF312 SPMS patients with progressing disease who are still able to walk. Description of Study/Trial: A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis. This study is designed to provide efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis (SPMS) and to obtain regulatory approval to make BAF312 available for clinical use worldwide. The primary objective is to demonstrate the efficacy of BAF312 relative to placebo in delaying the time to 3-month confirmed disability progression in patients with SPMS as measured by EDSS. The first key secondary objective is to demonstrate the efficacy of BAF312 relative to placebo in delaying the time to 3-month confirmed worsening of at least 20% from Baseline in the timed 25- foot walk test (T25W). The second key secondary objective is to demonstrate the efficacy of BAF312 relative to placebo in reducing the increase in T2 lesion volume from Baseline to the end of the study.

4 STRIVE RRMS patients who are making the decision to start using Tysabri. Biogen Description of Study/Trial: Phase 4; prospective, observational (non-interventional) study of approved and marketed Tysabri. The primary objective of the study is to determine which baseline and yearly response factors (clinical and para clinical) predict overall disease-free status at Month 12 and Month 24, and clinical disease-free status in subsequent Months 36 and 48. The response factors include clinical assessments of sustained EDSS progression, relapse status, and MRI measures, and patient reported outcomes (PROs) of cognition, capacity to work, quality of life (QoL), and visual function assessments.

5 ESTEEM Recruitment Period THROUGH 2016 RRMS patients who are making the decision to start using Tecfidera. Biogen Description of Study/Trial: A Multicenter, Global, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Tecfidera (Dimethyl Fumarate) When Used in Routine Medical Practice in the Treatment of Multiple Sclerosis (ESTEEM). The primary objective of the study is to determine the incidence, type, and pattern of serious adverse events (SAEs), including but not limited to infections (including opportunistic infections), hepatic events, malignancies, and renal events, and of AEs leading to treatment discontinuation in patients with MS treated with DMF.