Ignite Creation Date:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2025-12-30 @ 4:17 PM
Study NCT ID:
NCT01281657
Status:
COMPLETED
Last Update Posted:
2012-09-06
First Post:
2011-01-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Study of Fingolimod in MS Patients From the FTY Clinical Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-05', 'studyFirstSubmitDate': '2011-01-19', 'studyFirstSubmitQcDate': '2011-01-21', 'lastUpdatePostDateStruct': {'date': '2012-09-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long-term safety data in patients with relapsing forms of multiple sclerosis who have participated in clinical trials with fingolimod and who are now taking prescribed fingolimod under the conditions of routine medical practice', 'timeFrame': 'Throughout the entirety of the study up to a maximum of 8 years'}], 'secondaryOutcomes': [{'measure': 'Long-term effectiveness data, particularly including clinical disease and patient outcome related parameters such as relapse and disability', 'timeFrame': 'Throughout the entirety of the study up to a maximum of 8 years'}]}, 'conditionsModule': {'keywords': ['Fingolimod', 'FTY720', 'Relapsing forms of multiple sclerosis', 'Multiple sclerosis', 'MS', 'Safety', 'Efficacy'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this observational study is to collect long-term data on safety and effectiveness of fingolimod, particularly including clinical disease and patient outcome related parameters such as relapse and disability, in patients who have participated in prior trials within the fingolimod clinical development program. Furthermore, this study explores the incidence of selected safety related outcomes of fingolimod treatment during follow-up visits within the context of routine medical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with relapsing forms of MS who have participated in previous fingolimod trials and now taking commercially available fingolimod as part of routine medical care', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are prescribed fingolimod as part of their routine medical care\n* Patients who have participated in a prior fingolimod clinical trials\n\nExclusion Criteria:\n\n* Restrictions regarding the use of fingolimod while pregnant or nursing in accordance with the local prescribing label\n* Any patient who has prematurely discontinued from the previous fingolimod trial\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01281657', 'briefTitle': 'Long Term Study of Fingolimod in MS Patients From the FTY Clinical Program', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Long Term, Multicenter, Non-interventional, Observational Study Monitoring Long-term Safety and Effectiveness of Fingolimod 0.5 mg in Patients With Multiple Sclerosis Who Have Participated in the Fingolimod Clinical Development Program', 'orgStudyIdInfo': {'id': 'CFTY720D2399E1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prescribed fingolimod 0.5 mg/day', 'interventionNames': ['Drug: fingolimod']}], 'interventions': [{'name': 'fingolimod', 'type': 'DRUG', 'armGroupLabels': ['Prescribed fingolimod 0.5 mg/day']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35058', 'city': 'Cullman', 'state': 'Alabama', 'country': 'United States', 'facility': 'North Central Neurology Associates, PC', 'geoPoint': {'lat': 34.17482, 'lon': -86.84361}}, {'zip': '94705', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'The Research & Education Inst. of Alta Bates Summit Med. Grp', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Neuro-Therapeutics, Inc.', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '94117', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Multiple Sclerosis Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University/Lombardi Cancer Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Sunrise Clinical Research, Inc.', 'geoPoint': {'lat': 26.0112, 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