Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 11:46 PM
Study NCT ID:
NCT01695434
Status:
COMPLETED
Last Update Posted:
2013-03-25
First Post:
2012-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Longitudinal Study of Effect of Copaxone in RRMS Over 24 Months
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-21', 'studyFirstSubmitDate': '2012-09-26', 'studyFirstSubmitQcDate': '2012-09-27', 'lastUpdatePostDateStruct': {'date': '2013-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To explore whether treatment with GA may decrease iron deposition in subcortical deep GM, as detected by SWI-filtered phase imaging, in patients with RRMS over 24 months and compared to a reference population of healthy controls.', 'timeFrame': '24 months', 'description': 'MRI collected from RRMS patients who have taken Copaxone for 24 months'}], 'secondaryOutcomes': [{'measure': 'To investigate whether treatment with GA may decrease accumulation of iron in lesions, as detected by SWI-filtered phase imaging, in patients with RRMS over 24 months.', 'timeFrame': '24 months', 'description': 'Evaluate if Copaxone will decrease iron in lesions.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['multiple sclerosis', 'MRI', 'Copaxone', 'healthy controls', 'glatiramer acetate'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'To explore whether treatment with glatiramer acetate (GA) may decrease iron deposition in subcortical deep GM, as detected by SWI-filtered phase imaging, in patients with RRMS over 24 months and compared to a reference population of healthy controls.', 'detailedDescription': 'This is a prospective, observational, single-blinded, longitudinal, 24-month MRI study of the evolution of iron deposits, as evidenced by SWI-filtered phase imaging, in RRMS patients treated with GA and in healthy controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'MS patients from the Baird MS Center, The Jacobs Neurological Institute, Department of Neurology, State University at Buffalo, NY, USA who are also taking Copaxone as their disease modifying therapy.\n\nHealthy controls from the general population.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* MS patients diagnosed with clinically definite MS according to the McDonald criteria (Polman et al., 2005)\n* Being on GA monotherapy (20mg/day sc) for at least 24 months prior to the 24-month MRI scan\n* Having baseline clinical MRI scan that included SWI-filtered phase imaging in a 12-month window from the start day of the of the GA (MS patients)\n* Having baseline clinical MRI scan that included SWI-filtered phase imaging (healthy controls)\n* MS patients having a RR disease course (Lublin and Reingold, 1996)\n* Age 18-65 (healthy controls will be matched to MS patients for age and sex)\n* Signed informed consent at the 24-month follow-up\n* Pass MRI health screening\n* MS patients passing contrast screening\n* MS patients having normal kidney function (creatinine clearance \\>59)\n* None of the exclusion criteria\n\nExclusion Criteria:\n\n* Patients who had a relapse within 30 days prior to MRI baseline scan date\n* Patients who received steroid treatment within 30 days prior to the MRI baseline scan date\n* Women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study\n* MS patients who used other imunomodulatory or immunosuppressant treatment other than GA during the follow-up (e.g., IFN-β, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, IVIG, cellcept, natalizumab, etc.)\n* MS patients having abnormal kidney function (creatinine clearance \\<59)'}, 'identificationModule': {'nctId': 'NCT01695434', 'acronym': 'GASWI', 'briefTitle': 'A Longitudinal Study of Effect of Copaxone in RRMS Over 24 Months', 'organization': {'class': 'OTHER', 'fullName': 'University at Buffalo'}, 'officialTitle': 'A Prospective, Observational, Single-blinded, Longitudinal MRI Study of Effect of Glatiramer Acetate on Iron Deposition in Patients With Relapsing-remitting Multiple Sclerosis Over 24 Months', 'orgStudyIdInfo': {'id': 'GA-SWI 24'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Copaxone MRI', 'description': 'Patients with relapsing-remitting multiple sclerosis who take Copaxone will have a MRI.', 'interventionNames': ['Other: MRI']}, {'label': 'Healthy Controls MRI', 'description': 'Subjects who are otherwise healthy, without neurological disorders, will have a MRI.', 'interventionNames': ['Other: MRI']}], 'interventions': [{'name': 'MRI', 'type': 'OTHER', 'description': 'All subjects will undergo a MRI.', 'armGroupLabels': ['Copaxone MRI', 'Healthy Controls MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Buffalo Neuroimaging Analysis Center', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University at Buffalo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Buffalo Neuroimaging Analysis Center, Professor', 'investigatorFullName': 'Robert Zivadinov, MD, PhD', 'investigatorAffiliation': 'University at Buffalo'}}}}