ENGYNE Exploring Gilenya in Patients With Neutralizing Antibodies Against Interferon

A 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Fingolimod in the Treatment of Relapsing-remitting Multiple Sclerosis Patients With Neutralizing Antibodies to Interferon Beta

Study to evaluate efficacy of fingolimod in patients with neutralizing antibodies over 12 months

Inclusion Criteria:

• Male or female subjects aged 18-65 years
• Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria
• Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5
• Interferon-beta (IFN-β) treatment for at least 18 months.
• Positive IFN-NAb titer at screening or within 6 months prior to screening
• Patients with disease activity despite treatment with IFN-ß measured by gadolinium-enhancing lesions on T1-weighted images on MRI using a triple-dose gadolinium protocol and/or new or newly enlarging T2 lesions (T2 lesions: compared to a reference MRI performed within the last 18 months)

Exclusion Criteria:

• patients with previous or current disease of immune system
• active infections
• cardiovascular risk patients
• Patients unable to undergo MRI scans, including claustrophobia or history of hypersensitivity to gadolinium-DTPA

Other protocol-defined inclusion/exclusion criteria may apply