ENGYNE Exploring Gilenya in Patients With Neutralizing Antibodies Against Interferon (ENGYNE)
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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 Start Date
Estimated Primary Completion Date
Estimated Study Completion Date
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Number of patients with active MRI lesions [ Time Frame: 12 months ]
number of patients with neutralizing antibodies against IFN-ß with reduction of number of combined unique active lesions on brain MRI (CUAL) defined as those lesions that are new or recurrent or enlarging on T2-weighted scans or those that are new and taking Gd-enhancement on T1-weighted scans, avoiding double counting
Secondary Outcome Measures
Number of patients with adverse events [ Time Frame: 12 months ]
safety of fingolimod as measured by number of adverse events
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Ages Eligible for Study:
18 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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)
patients with previous or current disease of immune system
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