ENGYNE Exploring Gilenya in Patients With Neutralizing Antibodies Against Interferon

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01621269

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Drug: Fingolimod	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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 :

Jun 1, 2013

Anticipated Primary Completion Date :

Jun 1, 2014

Anticipated Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fingolimod	Drug: Fingolimod

Arm

Intervention/Treatment

Experimental: Fingolimod

Drug: Fingolimod

Outcome Measures

Primary Outcome Measures

Number of patients with active MRI lesions [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 [12 months]
safety of fingolimod as measured by number of adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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