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ENGYNE Exploring Gilenya in Patients With Neutralizing Antibodies Against Interferon (ENGYNE)

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01621269
First Posted: June 18, 2012
Last Update Posted: April 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
Study to evaluate efficacy of fingolimod in patients with neutralizing antibodies over 12 months

Condition Intervention Phase
Multiple Sclerosis Drug: Fingolimod Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Number of patients with active MRI lesions [ Time Frame: 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 [ Time Frame: 12 months ]
    safety of fingolimod as measured by number of adverse events


Enrollment: 0
Study Start Date: June 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fingolimod Drug: Fingolimod

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01621269


Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01621269     History of Changes
Other Study ID Numbers: CFTY720DDE12
First Submitted: April 24, 2012
First Posted: June 18, 2012
Last Update Posted: April 20, 2017
Last Verified: September 2014

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Multiple Sclerosis
MS
Fingolimod
Gilenya
Neutralizing Antibodies
NAb

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies
Immunoglobulins
Fingolimod Hydrochloride
Antibodies, Blocking
Interferons
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents