Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 11:37 PM
Study NCT ID:
NCT00097760
Status:
COMPLETED
Last Update Posted:
2009-06-18
First Post:
2004-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Natalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple Sclerosis
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': 'D000069442', 'term': 'Natalizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-17', 'studyFirstSubmitDate': '2004-11-30', 'studyFirstSubmitQcDate': '2004-11-30', 'lastUpdatePostDateStruct': {'date': '2009-06-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of development of new active lesions on MRI scans.', 'timeFrame': 'Week 20'}], 'secondaryOutcomes': [{'measure': 'Incidence and severity of adverse events.', 'timeFrame': 'Week 20'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Multiple Sclerosis', 'MS'], 'conditions': ['Multiple Sclerosis, Relapsing-Remitting']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.nationalmssociety.org', 'label': 'The website of the National Multiple Sclerosis Society, an organization dedicated to providing information to individuals with MS, their families, and healthcare providers.'}, {'url': 'http://www.msactivesource.com', 'label': 'MSActiveSource.com is a resource for news, information, and disease management for all individuals touched by Multiple Sclerosis. This site is sponsored by Biogen.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if natalizumab in combination with Glatiramer Acetate (GA) is safe and effective in delaying progression of individuals diagnosed with relapsing-remitting Multiple Sclerosis (MS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of MS as defined by McDonald et al., criteria # 1-4\n* Between the ages of 18 and 55, inclusive\n* Baseline EDSS score between 0.0 and 5.0, inclusive\n* Have been treated with GA for at least the 12 months prior to randomization\n\nExclusion Criteria:\n\n* Primary progressive, secondary progressive or progressive relapsing MS\n* MS relapse has occurred within the 50 days prior to randomization\n* A clinically significant infectious illness\n* History of, or abnormal lab result indicative of significant disease that would preclude the administration of a recombinant humanized antibody immunomodulating agent or GA for 20 weeks.'}, 'identificationModule': {'nctId': 'NCT00097760', 'briefTitle': 'Natalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'Safety Study of Natalizumab in Combination With Glatiramer Acetate (GA)', 'orgStudyIdInfo': {'id': 'C-1803'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Natalizumab 300 mg, IV infusion, every 4 weeks in addition to 20 mg of glatiramer acetate SC, daily, for up to 20 weeks.', 'interventionNames': ['Drug: Natalizumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 2', 'description': 'Placebo, by IV infusion, every 4 weeks in addition to 20 mg glatiramer acetate, by SC injection, daily, for up to 20 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Natalizumab', 'type': 'DRUG', 'otherNames': ['Tysabri'], 'description': 'Natalizumab 300 mg, IV infusion, every 4 weeks in addition to 20 mg of glatiramer acetate SC, daily, for up to 20 weeks.', 'armGroupLabels': ['Group 1']}, {'name': 'Natalizumab', 'type': 'DRUG', 'otherNames': ['Tysabri'], 'description': 'Natalizumab, 300 mg IV infusion, every 4 weeks for up to 20 weeks.', 'armGroupLabels': ['Group 1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo, by IV infusion, every 4 weeks in addition to 20 mg glatiramer acetate, by SC injection, daily, for up to 20 weeks.', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Biogen Idec, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biogen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Elan Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Biogen Idec MD', 'oldOrganization': 'Biogen Idec, Inc.'}}}}