Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2026-01-29 @ 9:29 PM
Study NCT ID:
NCT01941004
Status:
WITHDRAWN
Last Update Posted:
2017-04-21
First Post:
2013-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Fingolimod in MS Patients in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-20', 'studyFirstSubmitDate': '2013-09-09', 'studyFirstSubmitQcDate': '2013-09-09', 'lastUpdatePostDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of new/newly enlarged T2 MRI lesions over 6 months', 'timeFrame': '6 months', 'description': 'Cumulative number of new/newly enlarged T2 lesions over 6 months'}], 'secondaryOutcomes': [{'measure': 'annualized relapse rate (ARR)', 'timeFrame': '6 months', 'description': 'The annualized relapse rate (ARR) is identified as the average number of confirmed relapses per year (the total number of confirmed relapses divided by the total days in the study multiplied by 365.25). The number of relapses will include all the confirmed relapses during the study. The time spent in the study will correspond to the observation period for all the relapses from first dose on the study drug to end of study.'}, {'measure': 'number of Gd-enhancing T1 lesions', 'timeFrame': '6 months'}, {'measure': 'Safety and tolerability of fingolimod 0.5 mg compared to placebo', 'timeFrame': '12 months', 'description': 'Based on frequency of adverse events (the number and percentage of patients having any AE by primary system organ class and preferred term) and on the incidence of clinically notable abnormalities'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['multiple sclerosis (MS)', 'relapsing remitting multiple sclerosis (RRMS)', 'fingolimod'], 'conditions': ['Multiple Sclerosis (Relapsing Remitting)']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and efficacy of fingolimod 0.5mg vs. placebo in MS patients in China'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Patients must have relapsing remitting multiple sclerosis\n\nExclusion Criteria:\n\nPatients with:\n\n* History of chronic immune disease\n* Certain cancers\n* Uncontrolled diabetes\n* Certain eye disorders -Negative for varicella\n* zoster virus IgG antibodies\n* Certain hepatic conditions\n* Low white blood cell count\n* On certain immunosuppressive medications or heart medications\n* Certain heart conditions or certain lung conditions\n* Inability to undergo MRI scans -Diagnosis of Neuromyelitis optica.\n* Other protocol defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01941004', 'briefTitle': 'Safety and Efficacy of Fingolimod in MS Patients in China', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 12 Month Study, With a 6-month, Double-blind, Randomized, Placebo-controlled, Multi-center Parallel- Groups, Treatment Phase Evaluating Efficacy and Safety of Fingolimod 0.5 mg and a 6-month, Open-label, Treatment Phase, in Chinese Patients With Relapsing-remitting Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'CFTY720D2315'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'double blinded Fingolimod 6 mos + open label fingolimod 6 mos', 'description': 'Randomized to 6 month (180 days) 0.5 mg fingolimod + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily', 'interventionNames': ['Drug: fingolimod']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo 6 mos + open label fingolimod 6 mos', 'description': 'Randomized to 6 month (180 days) matching placebo + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily', 'interventionNames': ['Drug: Placebo (6mos) + open label fingolimod (6 mos)']}], 'interventions': [{'name': 'fingolimod', 'type': 'DRUG', 'description': 'Randomized to 6 month (180 days) 0.5 mg fingolimod + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily', 'armGroupLabels': ['double blinded Fingolimod 6 mos + open label fingolimod 6 mos']}, {'name': 'Placebo (6mos) + open label fingolimod (6 mos)', 'type': 'DRUG', 'description': 'Randomized to 6 month (180 days) matching placebo + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily', 'armGroupLabels': ['Placebo 6 mos + open label fingolimod 6 mos']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}