Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-31 @ 1:25 PM
Study NCT ID:
NCT00523328
Status:
TERMINATED
Last Update Posted:
2016-01-21
First Post:
2007-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BG9924 in Combination With Methotrexate Extension of Study 104RA203 (NCT 00458861)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D001168', 'term': 'Arthritis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053308', 'term': 'Lymphotoxin-beta'}], 'ancestors': [{'id': 'D048069', 'term': 'Tumor Necrosis Factors'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'whyStopped': 'Analysis of data from 104RA203 failed to meet primary endpoint.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'dispFirstSubmitDate': '2015-12-17', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-17', 'studyFirstSubmitDate': '2007-08-17', 'dispFirstSubmitQcDate': '2015-12-17', 'studyFirstSubmitQcDate': '2007-08-29', 'dispFirstPostDateStruct': {'date': '2016-01-21', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To observe the long-term treatment with BG9924 when administered to participants with RA who previously participated in a Biogen Idec Study.', 'timeFrame': 'The duration of this study is 18 months.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis', 'Arthritis', 'BG9924', 'methotrexate'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This study is to observe the long-term treatment of BG9924', 'detailedDescription': 'Extension study for 104RA203 (NCT 00458861)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be a participant from Study 104RA203 (NCT 00458861)\n\nExclusion Criteria:\n\n* Participants with a significant change in medical history from their previous BG9924 Study 104RA203 (NCT 00458861).\n* Nursing mothers, pregnant women, or women who are planning to become pregnant while in the study.\n* Male and female participants of child-bearing potential not willing to practice effective birth control for the duration of the study.\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00523328', 'briefTitle': 'BG9924 in Combination With Methotrexate Extension of Study 104RA203 (NCT 00458861)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'An Open-Label Extension Study to Evaluate the Safety and Efficacy of BG9924 When Given in Combination With Methotrexate to Subjects With Rheumatoid Arthritis Who Previously Participated in Study 104RA203', 'orgStudyIdInfo': {'id': '104RA205'}, 'secondaryIdInfos': [{'id': '2007-000734-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BG9924', 'description': 'dosage administered as per Biogen-idec protocol', 'interventionNames': ['Drug: BG9924']}], 'interventions': [{'name': 'BG9924', 'type': 'DRUG', 'otherNames': ['LTbeta'], 'description': 'dosage administered as per Biogen-idec protocol', 'armGroupLabels': ['BG9924']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Coordinating Research Site', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Coordinating Research Site', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': 'H9P 2V4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Coordinating Research Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'NE1 4LP', 'city': 'Newcastle', 'country': 'United Kingdom', 'facility': 'Coordinating Research Site', 'geoPoint': {'lat': 54.21804, 'lon': -5.88979}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biogen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}