ENGYNE Exploring Gilenya in Patients With Neutralizing Antibodies Against Interferon

Phase 4

Withdrawn

• Conditions: Multiple Sclerosis
• Interventions: Drug: Fingolimod

• Registration Number: NCT01621269
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-24
• Study First Submitted QC: 2012-06-15
• Study First Posted: 2012-06-18
• Study Start: 2013-06
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-09
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fingolimod	Fingolimod	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of patients with adverse events	12 months	safety of fingolimod as measured by number of adverse events