Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-01-01 @ 9:10 AM
Study NCT ID:
NCT00913432
Status:
COMPLETED
Last Update Posted:
2018-12-13
First Post:
2009-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Masitinib in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C526575', 'term': 'masitinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-12', 'studyFirstSubmitDate': '2009-06-03', 'studyFirstSubmitQcDate': '2009-06-03', 'lastUpdatePostDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'American College of Rheumatology Score 50', 'timeFrame': 'week 12'}], 'secondaryOutcomes': [{'measure': 'DAS28', 'timeFrame': 'week 4, 8 and 12'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rheumatoid arthritis', 'methotrexate', 'DMARD', 'c-kit inhibitor'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'A 12-week with possible extension, phase II study to compare efficacy and safety of masitinib at 3 and 6 mg/kg/day in combination with methotrexate, in treatment of patients with active rheumatoid arthritis refractory to standard treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Disease duration of at least 6 months Meet American College of Rheumatology (ACR) criteria for RA.\n2. ACR functional class I-III\n3. Have active RA\n4. Failed (defined as active RA with stable dose during 3 months) i. methotrexate or ii. any DMARD including anti TNF alpha if patients previously failed methotrexate or iii. methotrexate in combination with any DMARD including anti TNF alpha\n\nExclusion Criteria:\n\n1. Patient had a major surgery within 2 weeks prior to study entry.\n2. Life expectancy \\< 6 months.'}, 'identificationModule': {'nctId': 'NCT00913432', 'briefTitle': 'Masitinib in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'AB Science'}, 'officialTitle': 'A 12-week With Possible Extension, Prospective, Multicenter, Randomized, Open Label, Uncontrolled, 2-parallel Group, Phase II Study to Compare Efficacy and Safety of AB1010 at 3 and 6 mg/kg/Day in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis With Inadequate Response to 1. Methotrexate or to 2. Any DMARD Including Anti TNF Alpha if Patients Previously Failed Methotrexate or to 3. Methotrexate in Combination With Any DMARD Including Anti TNF Alpha', 'orgStudyIdInfo': {'id': 'AB06010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'masitinib 3 mg', 'description': 'masitinib 3 mg/kg/day', 'interventionNames': ['Drug: masitinib']}, {'type': 'EXPERIMENTAL', 'label': 'masitinib 6 mg', 'description': 'masitinib 6 mg/kg/day', 'interventionNames': ['Drug: masitinib']}], 'interventions': [{'name': 'masitinib', 'type': 'DRUG', 'otherNames': ['AB1010'], 'description': '3 mg/kg/day oral route', 'armGroupLabels': ['masitinib 3 mg']}, {'name': 'masitinib', 'type': 'DRUG', 'otherNames': ['AB1010'], 'description': 'masitinib 6 mg/kg/day oral route', 'armGroupLabels': ['masitinib 6 mg']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jacques Tebib, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Lyon Sud'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AB Science', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}