ENGYNE Exploring Gilenya in Patients With Neutralizing Antibodies Against Interferon

Phase 4WithdrawnNCT01621269

Novartis Pharmaceuticals

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Multiple Sclerosis

Interventions

FingolimodDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of patients with active MRI lesions

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

Time frame: 12 months

Secondary Outcomes

Number of patients with adverse events

safety of fingolimod as measured by number of adverse events

Time frame: 12 months

Data from ClinicalTrials.gov

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