Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2026-01-01 @ 4:33 PM
Study NCT ID:
NCT00819195
Status:
COMPLETED
Last Update Posted:
2013-10-08
First Post:
2008-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-Inflammatory Type II Monocyte Induction by Glatiramer Acetate (Copaxone) Treatment of Multiple Sclerosis
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': 'D000068717', 'term': 'Glatiramer Acetate'}], 'ancestors': [{'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Peripheral blood mononuclear cells (PBMC) Serum RNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-04', 'studyFirstSubmitDate': '2008-12-16', 'studyFirstSubmitQcDate': '2009-01-07', 'lastUpdatePostDateStruct': {'date': '2013-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Production of inflammatory cytokines by monocytes and naive T cells.', 'timeFrame': '0, 1, 2, 4, 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['relapsing-remitting', 'multiple sclerosis', 'Copaxone', 'glatiramer acetate', 'MS'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '17676050', 'type': 'BACKGROUND', 'citation': "Weber MS, Prod'homme T, Youssef S, Dunn SE, Rundle CD, Lee L, Patarroyo JC, Stuve O, Sobel RA, Steinman L, Zamvil SS. Type II monocytes modulate T cell-mediated central nervous system autoimmune disease. Nat Med. 2007 Aug;13(8):935-43. doi: 10.1038/nm1620. Epub 2007 Aug 5."}, {'pmid': '11288751', 'type': 'BACKGROUND', 'citation': 'Neuhaus O, Farina C, Wekerle H, Hohlfeld R. Mechanisms of action of glatiramer acetate in multiple sclerosis. Neurology. 2001 Mar 27;56(6):702-8. doi: 10.1212/wnl.56.6.702. No abstract available.'}, {'pmid': '16109363', 'type': 'BACKGROUND', 'citation': 'Farina C, Weber MS, Meinl E, Wekerle H, Hohlfeld R. Glatiramer acetate in multiple sclerosis: update on potential mechanisms of action. Lancet Neurol. 2005 Sep;4(9):567-75. doi: 10.1016/S1474-4422(05)70167-8.'}, {'pmid': '15153538', 'type': 'BACKGROUND', 'citation': 'Kim HJ, Ifergan I, Antel JP, Seguin R, Duddy M, Lapierre Y, Jalili F, Bar-Or A. Type 2 monocyte and microglia differentiation mediated by glatiramer acetate therapy in patients with multiple sclerosis. J Immunol. 2004 Jun 1;172(11):7144-53. doi: 10.4049/jimmunol.172.11.7144.'}, {'pmid': '15090474', 'type': 'BACKGROUND', 'citation': 'Weber MS, Starck M, Wagenpfeil S, Meinl E, Hohlfeld R, Farina C. Multiple sclerosis: glatiramer acetate inhibits monocyte reactivity in vitro and in vivo. Brain. 2004 Jun;127(Pt 6):1370-8. doi: 10.1093/brain/awh163. Epub 2004 Apr 16.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether glatiramer acetate (Copaxone) will induce anti-inflammatory type II monocyte development during treatment of MS, and if these antigen presenting cells (APC) will promote Th2 and Treg differentiation of naïve T cells.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Relapsing-remitting multiple sclerosis patients at the UCSF Multiple Sclerosis Center.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Relapsing-remitting (RR) MS patients (McDonald criteria)\n* Ages 18-55\n* Males and females\n* EDSS score ≤5\n* No prior treatment with Copaxone\n* Prior treatment with corticosteroids or interferon-beta (-1a or -1b) is acceptable, provided there is a washout period of at least one month\n\nExclusion Criteria:\n\n* Treatment with Tysabri, Novantrone or cyclophosphamide\n* Treatment with other immunomodulatory therapies (e.g. imuran, mycophenolate or methotrexate)\n* Primary-progressive (PP) and secondary-progressive (SP) multiple sclerosis\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00819195', 'briefTitle': 'Anti-Inflammatory Type II Monocyte Induction by Glatiramer Acetate (Copaxone) Treatment of Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Anti-Inflammatory Type II Monocyte Induction by Glatiramer Acetate (Copaxone) Treatment of Multiple Sclerosis', 'orgStudyIdInfo': {'id': '10-03877'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'RRMS', 'description': 'Relapsing-remitting multiple sclerosis patients who have not yet received glatiramer acetate (Copaxone) therapy recommended as part of clinical care', 'interventionNames': ['Drug: Glatiramer acetate']}, {'label': 'HC', 'description': 'Healthy control volunteers'}], 'interventions': [{'name': 'Glatiramer acetate', 'type': 'DRUG', 'otherNames': ['Copaxone'], 'description': '20 mg daily subcutaneous injection. Six-month duration.', 'armGroupLabels': ['RRMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Multiple Sclerosis Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Scott S. Zamvil, M.D. Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSF Department of Neurology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Multiple Sclerosis Society', 'class': 'OTHER'}, {'name': 'Teva Neuroscience, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}