Overview

ENGYNE Exploring Gilenya in Patients With Neutralizing Antibodies Against Interferon

Status:
Withdrawn

Trial end date:
2014-06-01

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Novartis Pharmaceuticals

Treatments:

Antibodies
Fingolimod Hydrochloride
Immunoglobulins
Interferons

Criteria

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