Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-01-26 @ 2:03 AM
Study NCT ID:
NCT00937157
Status:
COMPLETED
Last Update Posted:
2021-03-19
First Post:
2009-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of 1.5T vs. 3T Protocols After Treatment With Glatiramer Acetate (GA)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D007249', 'term': 'Inflammation'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068717', 'term': 'Glatiramer Acetate'}], 'ancestors': [{'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rzivadinov@bnac.net', 'phone': '716-859-7040', 'title': 'Robert Zivadinov, MD, PhD', 'organization': 'Buffalo Neuroimaging Analysis Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'RRMS Patients With >=1 GdE Lesion or Acute Relapse', 'description': 'Patients diagnosed with multiple sclerosis who have the presence of at least 1 or more Gd enhancing lesions and/or acute relapse.\n\nCopaxone: 12 MS patients were enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment was given on day 0. 1.5T and 3T scans were obtained according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids were also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days.', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'A Change in the Cumulative Number of Gd Enhancing Lesions Using a 3T Protocol.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}, {'units': 'GAD lesions', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Diagnosed With Multiple Sclerosis Who Have the Presen', 'description': 'Copaxone: 12 MS patients will be enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment will be given on day 0. 1.5T and 3T scans will be obtained and according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids will be also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days.'}], 'classes': [{'title': 'GAD lesions from 0-180', 'categories': [{'measurements': [{'value': '-3.7', 'spread': '5.8', 'groupId': 'OG000'}]}]}, {'title': 'GAD lesion from 0-360', 'categories': [{'measurements': [{'value': '-3.6', 'spread': '4.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline at 180 days and change from baseline at 360 days', 'unitOfMeasure': 'GAD lesions (number of)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'GAD lesions', 'denomUnitsSelected': 'GAD lesions', 'populationDescription': 'Of the 12 RRMS patients enrolled, only the 8 who completed days 180 and 360 were analyzed. There was no imputation used.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RRMS Patients With >=1 GdE Lesion or Acute Relapse', 'description': 'Patients diagnosed with multiple sclerosis who have the presence of at least 1 or more Gd enhancing lesions and/or acute relapse.\n\nCopaxone: 12 MS patients were enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment was given on day 0. 1.5T and 3T scans were obtained according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids were also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': "Recruitment from the pool of relapsing-remitting multiple sclerosis patients (RRMS) at the Jacob's Neurological Institute (JNI) was open for approximately one year.", 'preAssignmentDetails': 'All enrolled patients had to meet all inclusion criteria and no exclusion criteria. Patients were to be 18-65 years of age, have a disease duration of 3months to 20 years, be diagnosed with RRMS according to McDonald criteria, one enhancing lesion 30 days prior to screening and an EDSS score equal to or below 5.5.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients Diagnosed With Multiple Sclerosis Who Have the Presen', 'description': 'Copaxone: 12 MS patients will be enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment will be given on day 0. 1.5T and 3T scans will be obtained and according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids will be also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43', 'spread': '7.823', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-25', 'studyFirstSubmitDate': '2009-07-09', 'resultsFirstSubmitDate': '2014-12-02', 'studyFirstSubmitQcDate': '2009-07-09', 'lastUpdatePostDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-12-02', 'studyFirstPostDateStruct': {'date': '2009-07-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A Change in the Cumulative Number of Gd Enhancing Lesions Using a 3T Protocol.', 'timeFrame': 'Change from baseline at 180 days and change from baseline at 360 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Inflammation', 'Multiple Sclerosis', 'Glatiramer Acetate', 'Gd enhancing lesions', '1.5T protocol', '3T protocol', 'Magnetization transfer imaging (MTI)', 'Lesion activity analysis', 'Copaxone'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'This study will:\n\n* Explore whether GA decreases inflammation more on the 3T optimized protocol when compared to the 1.5T standard protocol.\n\n * Compare whether the decrease in the cumulative number of Gd-enhancing lesions significantly differs between pre-treatment (day 0) and post-treatment (12 months) using 1.5T standard and 3T optimized protocols.\n* Investigate the correlation between MTR and the cumulative number and volume of Gd enhancing lesions on 1.5T standard and 3T optimized protocols in patients treated with GA.\n\nThis study suggests that GA may favorably affect early events in lesion formation, in addition to exerting more transient beneficial effects on established areas of inflammation and demyelination, and that this effect may be observed only with the 3T optimized protocol.', 'detailedDescription': 'Interferon-β (IFN- β) and glatiramer acetate (GA) are the two main groups of drugs used in the treatment of multiple sclerosis (MS). Notably, while both ultimately decrease central nervous system (CNS) inflammation, they do so by very different mechanisms. Therefore, use of 1.5T MRI, triple dose of Gd, delay of scanning time for 20-30 min after Gd injection, and application of off-resonance saturated MT pulse may increase the ability to detect Gd lesions by approximately 120% when compared to 1.5T single dose MRI protocol. The 3T standard protocol may increase the ability to detect Gd enhancing lesions by 40-50% when compared to the 1.5T standard protocol. This may indicate that the 3T optimized protocol may increase the ability for Gd lesion detection by approximately 150-180%, when compared to the 1.5T standard protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with clinically definite MS according to the McDonald criteria\n* Have a Gd enhancing lesion using 1.5T standard protocol and/or an acute relapse\n* Age 18-65\n* Have a relapsing-remitting (RR) disease course or clinically isolated syndrome (CIS) with high risk of conversion to clinically definite (CD) MS (presence of \\>9 T2 lesions in addition to 1 Gd lesion)\n* Have EDSS scores less than or equal to 5.5\n* Have disease duration of 3 months to 30 years\n* None of the exclusion criteria\n\nExclusion Criteria:\n\n* Previous immunomodulatory or immunosuppressant treatment during the 30 days prior to day 0 of the study with the following agents (e.g., IFN-β, GA, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, IVIG, cellcept, natalizumab, etc.)'}, 'identificationModule': {'nctId': 'NCT00937157', 'briefTitle': 'Comparison of 1.5T vs. 3T Protocols After Treatment With Glatiramer Acetate (GA)', 'organization': {'class': 'OTHER', 'fullName': 'University at Buffalo'}, 'officialTitle': 'Comparison of Standard 1.5 Versus 3T Optimized Protocols in Patients Treated With Glatiramer Acetate. A Conventional and Non-conventional MRI Study', 'orgStudyIdInfo': {'id': 'BNAC/GA/01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'Patients diagnosed with multiple sclerosis who have the presence of at least 1 or more Gd enhancing lesions and/or acute relapse.', 'interventionNames': ['Drug: Copaxone']}], 'interventions': [{'name': 'Copaxone', 'type': 'DRUG', 'otherNames': ['Glatiramer acetate'], 'description': '12 MS patients will be enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment will be given on day 0. 1.5T and 3T scans will be obtained and according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids will be also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Jacobs Neurological Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Robert Zivadinov, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University at Buffalo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University at Buffalo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Teva Neuroscience, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Neurology', 'investigatorFullName': 'Robert Zivadinov, MD, PhD', 'investigatorAffiliation': 'University at Buffalo'}}}}