Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-25 @ 8:29 PM
Study NCT ID:
NCT01621269
Status:
WITHDRAWN
Last Update Posted:
2017-04-20
First Post:
2012-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ENGYNE Exploring Gilenya in Patients With Neutralizing Antibodies Against Interferon
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068876', 'term': 'Fingolimod Hydrochloride'}], 'ancestors': [{'id': 'D013110', 'term': 'Sphingosine'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011409', 'term': 'Propylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-19', 'studyFirstSubmitDate': '2012-04-24', 'studyFirstSubmitQcDate': '2012-06-15', 'lastUpdatePostDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with active MRI lesions', 'timeFrame': '12 months', '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'}], 'secondaryOutcomes': [{'measure': 'Number of patients with adverse events', 'timeFrame': '12 months', 'description': 'safety of fingolimod as measured by number of adverse events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple Sclerosis', 'MS', 'Fingolimod', 'Gilenya', 'Neutralizing Antibodies', 'NAb'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'Study to evaluate efficacy of fingolimod in patients with neutralizing antibodies over 12 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects aged 18-65 years\n* Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria\n* Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5\n* Interferon-beta (IFN-β) treatment for at least 18 months.\n* Positive IFN-NAb titer at screening or within 6 months prior to screening\n* 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)\n\nExclusion Criteria:\n\n* patients with previous or current disease of immune system\n* active infections\n* cardiovascular risk patients\n* Patients unable to undergo MRI scans, including claustrophobia or history of hypersensitivity to gadolinium-DTPA\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01621269', 'acronym': 'ENGYNE', 'briefTitle': 'ENGYNE Exploring Gilenya in Patients With Neutralizing Antibodies Against Interferon', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CFTY720DDE12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fingolimod', 'interventionNames': ['Drug: Fingolimod']}], 'interventions': [{'name': 'Fingolimod', 'type': 'DRUG', 'armGroupLabels': ['Fingolimod']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}