ENGYNE Exploring Gilenya in Patients With Neutralizing Antibodies Against Interferon

Novartis

Status and phase: Withdrawn; Phase 4

Conditions: Multiple Sclerosis

Treatments: Drug: Fingolimod

Study type: Interventional

Funder types: Industry

Identifiers

NCT01621269

CFTY720DDE12

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Fingolimod

Experimental group

Treatment:

Drug: Fingolimod