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

Primary Purpose

Multiple Sclerosis

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Fingolimod
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, MS, Fingolimod, Gilenya, Neutralizing Antibodies, NAb

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Fingolimod

    Arm Description

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Number of patients with adverse events
    safety of fingolimod as measured by number of adverse events

    Full Information

    First Posted
    April 24, 2012
    Last Updated
    April 19, 2017
    Sponsor
    Novartis Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01621269
    Brief Title
    ENGYNE Exploring Gilenya in Patients With Neutralizing Antibodies Against Interferon
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2014
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    June 2013 (undefined)
    Primary Completion Date
    June 2014 (Anticipated)
    Study Completion Date
    June 2014 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Novartis Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis
    Keywords
    Multiple Sclerosis, MS, Fingolimod, Gilenya, Neutralizing Antibodies, NAb

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Fingolimod
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Fingolimod
    Primary Outcome Measure Information:
    Title
    Number of patients with active MRI lesions
    Description
    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
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Number of patients with adverse events
    Description
    safety of fingolimod as measured by number of adverse events
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Novartis Pharmaceuticals
    Organizational Affiliation
    Novartis Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    ENGYNE Exploring Gilenya in Patients With Neutralizing Antibodies Against Interferon

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