Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-27 @ 9:24 PM
Study NCT ID:
NCT01410695
Status:
TERMINATED
Last Update Posted:
2018-12-17
First Post:
2011-08-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Masitinib in Refractory Active Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France', 'United States']}, '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'}, {'id': 'D008727', 'term': 'Methotrexate'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 324}}, 'statusModule': {'whyStopped': 'Sponsor decision based on portfolio prioritization', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'dispFirstSubmitDate': '2018-12-12', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-13', 'studyFirstSubmitDate': '2011-08-04', 'dispFirstSubmitQcDate': '2018-12-13', 'studyFirstSubmitQcDate': '2011-08-04', 'dispFirstPostDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ACR50', 'timeFrame': 'week 24'}], 'secondaryOutcomes': [{'measure': 'ACR', 'timeFrame': 'week 12'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis', 'RA', 'masitinib', 'DMARD', 'methotrexate'], 'conditions': ['Rheumatoid Arthritis (RA)']}, 'descriptionModule': {'briefSummary': 'The objective is to compare efficacy and safety of masitinib at 3 and 6 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient with rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria for at least 6 months\n2. Patient with ACR functional class I-III\n3. Patient who have active RA\n4. Patient who failed (defined as active RA with stable dose during 3 months) methotrexate or any DMARD including biologics drugs if patients previously failed methotrexate or methotrexate in combination with any DMARD including biologics drugs\n5. Patient with a disease onset at \\> 16 years of age\n\nExclusion Criteria:\n\n1. Patient for whom the use of methotrexate is contraindicated as per its SPC\n2. Patient with documented fibromyalgia\n3. Patient with lactose intolerance\n4. Patient presenting with cardiac disorders'}, 'identificationModule': {'nctId': 'NCT01410695', 'briefTitle': 'Masitinib in Refractory Active Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'AB Science'}, 'officialTitle': 'A 24-week With Possible Extension, Prospective, Multicenter, Randomised, Double-blind, Controlled, 3-parallel Groups, Phase 2b/3 Study to Compare Efficacy and Safety of Masitinib at 3 and 6 mg/kg/Day to Methotrexate, With a Randomisation 1:1:1, in Treatment of Patients With Active Rheumatoid Arthritis With Inadequate Response to 1. Methotrexate or to 2. Any DMARD Including at Least One Biologic Drug if Patients Previously Failed Methotrexate or to 3. Methotrexate in Combination With Any DMARD Including Biologic Drugs', 'orgStudyIdInfo': {'id': 'AB06012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'masitinib 3 mg', 'description': 'masitinib 3 mg/kg/day, tablets, orally, twice a day', 'interventionNames': ['Drug: masitinib 3 mg', 'Drug: Placebo (methotrexate)']}, {'type': 'EXPERIMENTAL', 'label': 'masitinib 6.0 mg', 'description': 'masitinib 6.0 mg/kg/day, tablets, orally, twice a day', 'interventionNames': ['Drug: masitinib 6.0 mg', 'Drug: Placebo (methotrexate)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'methotrexate', 'description': 'methotrexate at the dose of 15 or 20 mg per week', 'interventionNames': ['Drug: methotrexate', 'Drug: Placebo (masitinib)']}], 'interventions': [{'name': 'masitinib 3 mg', 'type': 'DRUG', 'otherNames': ['AB1010'], 'armGroupLabels': ['masitinib 3 mg']}, {'name': 'masitinib 6.0 mg', 'type': 'DRUG', 'otherNames': ['AB1010'], 'armGroupLabels': ['masitinib 6.0 mg']}, {'name': 'methotrexate', 'type': 'DRUG', 'armGroupLabels': ['methotrexate']}, {'name': 'Placebo (methotrexate)', 'type': 'DRUG', 'armGroupLabels': ['masitinib 3 mg', 'masitinib 6.0 mg']}, {'name': 'Placebo (masitinib)', 'type': 'DRUG', 'armGroupLabels': ['methotrexate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25301', 'city': 'Hostivice', 'country': 'Czechia', 'facility': 'ARTMEDI UPD s.r.o', 'geoPoint': {'lat': 50.08158, 'lon': 14.25856}}], 'overallOfficials': [{'name': 'Jacques Tebib, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Lyon Sud, Pierre-Bénite, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AB Science', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}