Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2026-01-27 @ 6:00 AM
Study NCT ID:
NCT00030966
Status:
COMPLETED
Last Update Posted:
2009-06-18
First Post:
2002-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Natalizumab in Combination With Avonex in the Treatment of 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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-17', 'studyFirstSubmitDate': '2002-02-15', 'studyFirstSubmitQcDate': '2002-02-15', 'lastUpdatePostDateStruct': {'date': '2009-06-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary objectives of this study are to determine if natalizumab is effective in reducing the rate of clinical relapse at 1 year and in slowing the progression of disability at 2 years as measured by EDSS.', 'timeFrame': '1 year and 2 years'}], 'secondaryOutcomes': [{'measure': 'If this combination reduces MRI lesions and the overall rate of clinical relapses', 'timeFrame': '1 year and 2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Multiple Sclerosis', 'MS'], 'conditions': ['Multiple Sclerosis, Relapsing-Remitting']}, 'referencesModule': {'references': [{'pmid': '16510745', 'type': 'RESULT', 'citation': 'Rudick RA, Stuart WH, Calabresi PA, Confavreux C, Galetta SL, Radue EW, Lublin FD, Weinstock-Guttman B, Wynn DR, Lynn F, Panzara MA, Sandrock AW; SENTINEL Investigators. Natalizumab plus interferon beta-1a for relapsing multiple sclerosis. N Engl J Med. 2006 Mar 2;354(9):911-23. doi: 10.1056/NEJMoa044396.'}, {'pmid': '37173129', 'type': 'DERIVED', 'citation': 'Strijbis EM, Coerver E, Mostert J, van Kempen ZLE, Killestein J, Comtois J, Repovic P, Bowen JD, Cutter G, Koch M. Association of age and inflammatory disease activity in the pivotal natalizumab clinical trials in relapsing-remitting multiple sclerosis. J Neurol Neurosurg Psychiatry. 2023 Oct;94(10):792-799. doi: 10.1136/jnnp-2022-330887. Epub 2023 May 12.'}], 'seeAlsoLinks': [{'url': 'http://www.nationalmssociety.org', 'label': 'The web site 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 AVONEX 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 Avonex for at least the 12 months prior to randomization\n* Have experienced at least one relapse (while on Avonex) within the 12 months prior to randomization.\n* Cranial MRI scan demonstrating lesions consistent with MS.\n* Have given written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Primary progressive, secondary progressive, or progressive relapsing MS.\n* MS relapse has occurred within 50 days of randomization\n* A clinically significant infectious illness within 30 days prior to randomization\n* History of, or abnormal lab result, indicative of significant disease, that in the opinion of the investigator, would preclude the administration of a recombinant humanized antibody immunomodulating agent or Avonex for 116 weeks.\n* History of severe allergic or anaphylactic reactions or known drug hypersensitivity.\n* Unable to perform the Timed 25-Foot Walk, 9HPT and PASAT 3\n* Abnormal blood tests at Screening Visit'}, 'identificationModule': {'nctId': 'NCT00030966', 'briefTitle': 'Safety and Efficacy of Natalizumab in Combination With Avonex in the Treatment of Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab, When Added to Avonex® (Interferon Beta-1a), in Subjects With Relapsing-Remitting Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'C-1802'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Adding natalizumab monthly infusion to Avonex weekly injection for up to 116 weeks.', 'interventionNames': ['Drug: Natalizumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 2', 'description': 'Adding placebo monthly infusion to Avonex weekly injection for up to 116 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Natalizumab', 'type': 'DRUG', 'otherNames': ['Tysabri'], 'description': 'Natalizumab, 300 mg, monthly IV infusion for up to 116 weeks.', 'armGroupLabels': ['Group 1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo monthly infusion for up to 116 weeks.', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 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'United States', 'facility': 'Kaiser-Permanente Medical Center', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'zip': '94117', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'MS Center at UCSF', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80910', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Healthsouth Rehabilitation Hospital', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80262', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado MS Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06418', 'city': 'Derby', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Griffin Hospital', 'geoPoint': {'lat': 41.32065, 'lon': -73.089}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown Univesity Hospital, Research 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