Ignite Creation Date:
2025-12-24 @ 12:01 PM
Ignite Modification Date:
2026-02-22 @ 4:35 AM
Study NCT ID:
NCT02232061
Status:
COMPLETED
Last Update Posted:
2021-02-10
First Post:
2014-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@Novartis.com', 'phone': '+1 862 778 8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This study had no stand-alone secondary objectives. However, data from the CFTY720D2409 and D2406 studies will be pooled to supplement this study and will be appended to this record when available.'}}, 'adverseEventsModule': {'timeFrame': 'Within 6 months of qualifying event up to approximately 64 months', 'eventGroups': [{'id': 'EG000', 'title': 'Fingolimod', 'description': 'Fingolimod 0.5mg/day tablets taken orally', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'LYMPHOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'HYPOTHYROIDISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'HAEMORRHOIDAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'TRICHOMONIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'VIRAL PHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'INFUSION RELATED REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'FOLATE DEFICIENCY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'HYPERCHOLESTEROLAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'HYPERPHAGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'VITAMIN D DEFICIENCY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'BURSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'FACET JOINT SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'MUSCULAR WEAKNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'TENDONITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'MULTIPLE SCLEROSIS RELAPSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'SCIATICA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'PREGNANCY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'OROPHARYNGEAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'HOT FLUSH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}], 'seriousEvents': [{'term': 'LYMPHOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'BRONCHITIS VIRAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'BASAL CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'ASTHMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participants Who Experienced at Least One Qualifying Cardiovascular Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod', 'description': 'Fingolimod 0.5mg/day tablets taken orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 6 months of qualifying event up to 64 months', 'description': 'Participants from study CFTY720D2406 who experienced a qualifying cardiovascular adverse event were transferred to this study. Qualifying cardiovascular events included, but were not limited to, sudden unexplained death, cardiovascular death, myocardial infarction (MI), Q-wave MI, stroke (ischemic or hemorrhagic), unstable angina requiring hospitalization, congestive heart failure requiring hospitalization, complete heart block, ventricular fibrillation, torsade de pointes, hypertensive emergency and any other suspected life threatening cardiovascular condition.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fingolimod', 'description': 'Fingolimod 0.5mg/day tablets taken orally.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Patients enrolled in study CFTY720D2406 who experienced a cardiovascular event within 24-hours of fingolimod treatment initiation/re-initiation which led to overnight monitoring or met serious adverse event criteria, were eligible to participate in this study CFTY720D2409.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Fingolimod', 'description': 'Fingolimod 0.5mg/day tablets taken orally.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Ages 21 - 47', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-08', 'size': 489030, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-01-21T11:29', 'hasProtocol': True}, {'date': '2020-08-21', 'size': 1119858, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-01-21T11:29', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-01-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-21', 'studyFirstSubmitDate': '2014-09-02', 'resultsFirstSubmitDate': '2021-01-21', 'studyFirstSubmitQcDate': '2014-09-02', 'lastUpdatePostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-21', 'studyFirstPostDateStruct': {'date': '2014-09-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participants Who Experienced at Least One Qualifying Cardiovascular Adverse Event', 'timeFrame': 'Within 6 months of qualifying event up to 64 months', 'description': 'Participants from study CFTY720D2406 who experienced a qualifying cardiovascular adverse event were transferred to this study. Qualifying cardiovascular events included, but were not limited to, sudden unexplained death, cardiovascular death, myocardial infarction (MI), Q-wave MI, stroke (ischemic or hemorrhagic), unstable angina requiring hospitalization, congestive heart failure requiring hospitalization, complete heart block, ventricular fibrillation, torsade de pointes, hypertensive emergency and any other suspected life threatening cardiovascular condition.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['multiple sclerosis, fingolimod, adult, FTY720, inflammatory disease, demyelination, auto-inflammatory disease, relapsing-remitting MS, CFTY720D2406'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'This study will evaluate if patients who had a serious cardiovascular event upon initiation of fingolimod are at risk to delevop long term other cardiovascular events', 'detailedDescription': 'This was a multi-national, long-term safety study. Patients enrolled in study FTY720D2406 who experienced a cardiovascular event within 24-hours of fingolimod treatment initiation which led to overnight monitoring or met serious adverse event criteria, were eligible to participate in this study.\n\nPatients who experienced a qualifying event in study CFTY720D2406 started study CFTY720D2409 approximately 6 months after the occurrence of the CFTY720D2406 qualifying event.\n\nPatients underwent mandatory assessments on a 6-monthly basis including 12-lead ECG, vital signs. Other assessments were performed as per routine practice.\n\nThe primary objective of the study was to estimate the long-term cardiovascular risk of fingolimod in patients who experienced a cardiovascular event during treatment initiation.\n\nThe study has no stand-alone secondary objective. However data from the CFTY720D2409 and CFTY720D2406 studies will be pooled to supplement CFTY720DD2406 study and support its primary and secondary objectives of evaluating the safety profile of fingolimod.\n\nThe pooled data will be appended to this result upon completion of FDA submission.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients participating in study FTY720D2406 who experienced a serious cardiovascular event during their fingolimod treatment initiation or re-initiation which led to overnight monitoring or met seriousness criteria.\n* Patients still on fingolimod after the this first dose serious event\n\nExclusion Criteria:\n\n-Treatment with any investigational drug unless it is received as part of a Novartis sponsored MS study lasting less than 1 month'}, 'identificationModule': {'nctId': 'NCT02232061', 'briefTitle': 'Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks in Patients Treated With Fingolimod', 'orgStudyIdInfo': {'id': 'CFTY720D2409'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fingolimod', 'description': 'Fingolimod 0.5mg/day tablets taken orally.', 'interventionNames': ['Drug: Fingolimod']}], 'interventions': [{'name': 'Fingolimod', 'type': 'DRUG', 'otherNames': ['FTY720'], 'description': 'Fingolimod 0.5 mg tablet', 'armGroupLabels': ['Fingolimod']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3500', 'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'zip': '88212', 'city': 'Ravensburg', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.78198, 'lon': 9.61062}}, {'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on\n\nhttps://www.clinicalstudydatarequest.com/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}