ENGYNE Exploring Gilenya in Patients With Neutralizing Antibodies Against Interferon

Multiple Sclerosis Clinical Trial

— ENGYNE  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01621269
• Other study ID #: CFTY720DDE12
• Status: Withdrawn
• Phase: Phase 4
• First received: April 24, 2012
• Last updated: April 19, 2017
• Start date: June 2013
• Est. completion date: June 2014

Study information

• Verified date: September 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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-ß) 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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• Fingolimod

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Secondary	Number of patients with adverse events	safety of fingolimod as measured by number of adverse events	12 months