Ignite Creation Date:
2025-12-17 @ 1:42 PM
Ignite Modification Date:
2025-12-23 @ 9:57 PM
Study NCT ID:
NCT00458861
Status:
TERMINATED
Last Update Posted:
2016-01-21
First Post:
2007-03-22
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BG9924 in Combination With Methotrexate for Participants With Active Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'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'}]}}, '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': 115}}, 'statusModule': {'whyStopped': 'Interim analysis of data failed to meet primary endpoint.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'dispFirstSubmitDate': '2015-12-17', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-17', 'studyFirstSubmitDate': '2007-03-22', 'dispFirstSubmitQcDate': '2015-12-17', 'studyFirstSubmitQcDate': '2007-04-09', 'dispFirstPostDateStruct': {'date': '2016-01-21', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate efficacy of BG9924 in combination with methotrexate in RA participants who have had an inadequate response to anti-TNF therapy', 'timeFrame': '26 weeks'}], 'secondaryOutcomes': [{'measure': 'Assess the safety and tolerability of BG9924 in this participant population.', 'timeFrame': '26 weeks'}, {'measure': 'Assess the pharmacokinetic and pharmacodynamic profile of BG9924 in this participant population.', 'timeFrame': '26 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Active Rheumatoid Arthritis (RA)'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This Phase 2b study is designed to evaluate the efficacy and safety of BG9924 given subcutaneously (SC) versus placebo in participants with active rheumatoid arthritis (RA) who have previously had an inadequate response to treatment with anti-tumor necrosis factor (anti-TNF) therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Diagnosis of rheumatoid arthritis (functional class I - III) at least 6 months prior to baseline\n* Methotrexate (10 mg/week to 25 mg/week) \\> 3 months prior to Day 0 (stable dose \\> 4 weeks prior to Day 0)\n* Must have had an inadequate response to anti-TNF therapy due to inadequate efficacy\n\nKey Exclusion Criteria:\n\nMedical History\n\n* Serious local infection or systemic infection within 3 months of Day 0\n* History (Hx) of recurrent infections requiring oral or parental anti-infective treatment\n* Hx of tuberculosis (TB) or positive purified protein derivative (PPD) test during the screening period\n\nLaboratory Tests\n\n* Clinically significant lab tests at screening; or\n* Positive for hepatitis C antibody or hepatitis B at screening\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00458861', 'briefTitle': 'BG9924 in Combination With Methotrexate for Participants With Active Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, PK, and PD of BG9924 When Given in Combo With MTX to Subjects With Active RA Who Have Had an Inadequate Response to Anti-TNF', 'orgStudyIdInfo': {'id': '104RA203'}, 'secondaryIdInfos': [{'id': '2006-005467-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BG9924', 'description': 'Subcutaneous administration of BG9924 given every other week for 12 weeks', 'interventionNames': ['Biological: BG9924']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subcutaneous administration of placebo given every other week for 12 weeks', 'interventionNames': ['Other: Placebo Comparator']}], 'interventions': [{'name': 'BG9924', 'type': 'BIOLOGICAL', 'description': 'Subcutaneous administration of BG9924 given every other week for 12 weeks', 'armGroupLabels': ['BG9924']}, {'name': 'Placebo Comparator', 'type': 'OTHER', 'description': 'Subcutaneous administration of placebo given every other week for 12 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93404', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biogen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}