Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-01-04 @ 8:08 PM
Study NCT ID:
NCT00162292
Status:
COMPLETED
Last Update Posted:
2010-03-02
First Post:
2005-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multiple Ascending Dose Study of BMS-582949 in Patients With Stable Rheumatoid Arthritis on the Methotrexate Background
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': 'C552704', 'term': '4-(5-(cyclopropylcarbamoyl)-2-methylphenylamino)-5-methyl-N-propylpyrrolo(1,2-f)(1,2,4)triazine-6-carboxamide'}, {'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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'dispFirstSubmitDate': '2010-02-27', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-27', 'studyFirstSubmitDate': '2005-09-09', 'dispFirstSubmitQcDate': '2010-02-27', 'studyFirstSubmitQcDate': '2005-09-09', 'dispFirstPostDateStruct': {'date': '2010-03-02', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2010-03-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate safety and tolerability of BMS-582949 in subjects with active rheumatoid arthritis receiving concomitant MTX at steady state', 'timeFrame': 'during 28 doses of treatment'}], 'secondaryOutcomes': [{'measure': 'To evaluate the PK of BMS-582949 in clinically stable RA subjects on stable doses of MTX and concomitant BMS-582949'}, {'measure': 'To explore DAS28, ESR, RF and CRP of clinically stable doses of MTX and concomitant BMS-582949 compared to MTX alone', 'timeFrame': 'during 28 days of treatment'}, {'measure': 'To evaluate PK of MTX in stable RA subjects in the absence and presence of BMS-582949 for subjects enrolled prior to approval of amendment 2'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical research study is to learn if it is safe for rheumatoid arthritis patients to take BMS-582949 along with methotrexate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-70 years\n* Diagnosis of RA for ≥6 months\n* Swollen or tender joint or ESR \\>ULN. Subject must be on stable doses of MTX\n* Women of Childbearing Potential\n\nExclusion Criteria:\n\n* Serum transaminase levels \\>ULN\n* CK\\>ULN\n* Cannot have taken Orencia or Remicade within 8 weeks of baseline, Humira or Enbrel within 4 weeks of baseline\n* Use of H2 blockers or Proton Pump inhibitors while on study'}, 'identificationModule': {'nctId': 'NCT00162292', 'briefTitle': 'Multiple Ascending Dose Study of BMS-582949 in Patients With Stable Rheumatoid Arthritis on the Methotrexate Background', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Multiple Ascending Dose Study of BMS-582949 in Patients With Stable Rheumatoid Arthritis on the Methotrexate Background', 'orgStudyIdInfo': {'id': 'IM119-010'}}, 'armsInterventionsModule': {'interventions': [{'name': 'BMS-582949 and Methotrexate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92260', 'city': 'Palm Desert', 'state': 'California', 'country': 'United States', 'facility': 'Desert Medical Advances', 'geoPoint': {'lat': 33.72255, 'lon': -116.37697}}, {'zip': '91786', 'city': 'Upland', 'state': 'California', 'country': 'United States', 'facility': 'Boling Clinical Trials', 'geoPoint': {'lat': 34.09751, 'lon': -117.64839}}, {'zip': '33484', 'city': 'Delray Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Delray Research Associates', 'geoPoint': {'lat': 26.46146, 'lon': -80.07282}}, {'zip': '34474', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Ocala Rheumatology Research Center', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '02720', 'city': 'Fall River', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Phase Iii Clinical Research', 'geoPoint': {'lat': 41.70149, 'lon': -71.15505}}, {'zip': '75247', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Covance Clinical Research Unit Inc.', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78217', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Radiant Research San Antonio Northeast', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Healthcare Discoveries, Inc', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '37520', 'city': 'León', 'state': 'Guanajuato', 'country': 'Mexico', 'facility': 'Local Institution', 'geoPoint': {'lat': 21.12908, 'lon': -101.67374}}, {'zip': '52140', 'city': 'Metepec', 'state': 'State of Mexico', 'country': 'Mexico', 'facility': 'Local Institution', 'geoPoint': {'lat': 19.25934, 'lon': -99.60175}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'Bristol-Myers Squibb'}}}}