Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 12:30 AM
Study NCT ID:
NCT00915460
Status:
COMPLETED
Last Update Posted:
2009-06-08
First Post:
2009-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-Label Safety Extension Study of Avonex
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': 'D000068556', 'term': 'Interferon beta-1a'}], 'ancestors': [{'id': 'D016899', 'term': 'Interferon-beta'}, {'id': 'D007370', 'term': 'Interferon Type I'}, {'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 408}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2003-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-05', 'studyFirstSubmitDate': '2009-06-05', 'studyFirstSubmitQcDate': '2009-06-05', 'lastUpdatePostDateStruct': {'date': '2009-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective of this study is to collect data on serious adverse events which occur during extended treatment with AVONEX in subjects at high risk for developing MS and in subjects with secondary progressive MS.', 'timeFrame': 'The study duration is 7 months'}], 'secondaryOutcomes': [{'measure': 'To monitor the occurrence of diagnosed clinically definite multiple sclerosis (CDMS) in subjects who enter this study at high risk for developing MS following an initial demyelinating event.', 'timeFrame': 'The study duration is 7 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Multiple Sclerosis', 'Avonex', 'Interferon beta-1a', 'patients at high risk to develop multiple sclerosis'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'To collect data on serious adverse events which occur during extended treatment with Avonex in subjects at high risk for developing multiple sclerosis (MS) and in subjects with secondary progressive MS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have completed (as defined below) one of the following Biogen AVONEX® clinical studies and meet the other criteria indicated.\n* Subjects enrolled from studies C95-812 and C97-830 must have completed their respective study within 12 months prior to enrollment in C98-838. Subjects enrolled from study C96-823 must have completed the study within 24 months prior to enrollment in C98-838.\n* have not been diagnosed with any other disease that accounts for their neurologic symptoms.\n\nExclusion Criteria:\n\n* History of any significant cardiac, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude therapy with interferon beta.\n* History of severe allergic or anaphylactic reactions or history of hypersensitivity to human albumin.\n* History of seizure within the 3 months prior to enrollment.\n* Abnormal laboratory results at the screening visit:\n* History of suicidal ideation or an episode of severe depression within the 3 months prior to enrollment into this study.\n\nOther inclusion and exclusion criteria apply as per Biogen Idec Protocol'}, 'identificationModule': {'nctId': 'NCT00915460', 'briefTitle': 'Open-Label Safety Extension Study of Avonex', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'An Open-Label Safety Extension Study of AVONEX® (Interferon Beta-1a) Treatment in Subjects Who Completed Biogen Studies C95-812, C96-823, or C97-830', 'orgStudyIdInfo': {'id': 'C-98-838'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Patients previously enrolled in BIogen Idec study C95-812.', 'interventionNames': ['Drug: Interferon beta-1a (Avonex)']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Patients previously enrolled in Biogen Idec study C96-823.', 'interventionNames': ['Drug: Interferon beta-1a (Avonex)']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Patients previously enrolled in Biogen Idec study C97-830.', 'interventionNames': ['Drug: Interferon beta-1a (Avonex)']}], 'interventions': [{'name': 'Interferon beta-1a (Avonex)', 'type': 'DRUG', 'otherNames': ['Avonex'], 'description': 'dosage and frequency as per Biogen Idec protocol', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Biogen-Idec Investigator', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biogen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Biogen Idec MD', 'oldOrganization': 'Biogen Idec'}}}}