Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-25 @ 8:07 PM
Study NCT ID:
NCT00605735
Status:
COMPLETED
Last Update Posted:
2015-10-12
First Post:
2008-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PoC in Rheumatoid Arthritis With Methotrexate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D046248', 'term': 'Pyloric Stenosis, Hypertrophic'}], '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'}, {'id': 'D011707', 'term': 'Pyloric Stenosis'}, {'id': 'D017219', 'term': 'Gastric Outlet Obstruction'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'dispFirstSubmitDate': '2010-09-10', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-23', 'studyFirstSubmitDate': '2008-01-18', 'dispFirstSubmitQcDate': '2010-09-13', 'studyFirstSubmitQcDate': '2008-01-18', 'dispFirstPostDateStruct': {'date': '2010-09-15', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint is the proportion of subjects achieving an ACR 20 at Week 12', 'timeFrame': 'at Week 12'}], 'secondaryOutcomes': [{'measure': 'Proportion of subjects achieving an ACR 20', 'timeFrame': 'at each scheduled visit'}, {'measure': 'Proportion of subjects schieving and ACR 50', 'timeFrame': 'at each scheduled visit'}, {'measure': 'Proportion of subjects schieving and ACR 70', 'timeFrame': 'at each scheduled visit'}, {'measure': 'Percent change from baseline to each scheduled visit in DAS28 score', 'timeFrame': 'at each scheduled visit'}, {'measure': 'Percent change from baseline to each scheduled visit in ACR scores', 'timeFrame': 'at each scheduled visit'}, {'measure': 'Proportion of subjects schieving a 20% change in assessment of pain, disease activity and fatigue', 'timeFrame': 'at each scheduled visit'}, {'measure': 'Percent change from baseline to each scheduled visit in HAQ score', 'timeFrame': 'at each scheduled visit'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis, NOS']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out if 300 mg of BMS-582949 given once daily will be more effective than placebo after 12 weeks of treatment in subjects with rheumatoid arthritis who are also taking methotrexate'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have a diagnosis of RA for at least 6 months\n* Must be taking methotrexate for at least 3 months \\& on a stable dose of 7.5-30 mg weekly) for 4 weeks before dosing with study medication\n* Must have at least 6 swollen and at least 8 tender joints\n* CRP above upper limit of normal or ESR \\> 28 mm/hr\n* Must wash-out (stop taking) other immunosuppressant medications to treat RA (except for methotrexate) before dosing with study medication\n\nExclusion Criteria:\n\n* Any infection including TB, HIV, Hepatitis B or C\n* Recent infection requiring antibiotics within 4 weeks\n* History of gastrointestinal disease (such as GERD, gastrointestinal ulcers, heartburn) requiring medical or surgical treatment within 3 months\n* Chronic use of proton pump inhibitors (such as Losec, Prilosec, Prevacid, Nexium), H2 blockers (such as Tagamet, Pepcid, Zantac, Axid) or antacids (such as Mylanta, Maalox)'}, 'identificationModule': {'nctId': 'NCT00605735', 'briefTitle': 'PoC in Rheumatoid Arthritis With Methotrexate', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Randomized, Parallel Group, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of BMS-582949 Given Orally to Subjects With Rheumatoid Arthritis Having an Inadequate Response to Methotrexate', 'orgStudyIdInfo': {'id': 'IM119-015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A1', 'interventionNames': ['Drug: BMS-582949']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'P1', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BMS-582949', 'type': 'DRUG', 'otherNames': ['P38 Inflamation'], 'description': 'Tablets, Oral, 300 mg, once daily, 12 weeks', 'armGroupLabels': ['A1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablets, Oral, placebo, once daily, 12 weeks', 'armGroupLabels': ['P1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92260', 'city': 'Palm Desert', 'state': 'California', 'country': 'United States', 'facility': 'Desert Medical Advances', 'geoPoint': {'lat': 33.72255, 'lon': -116.37697}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Orrin M. Troum,M D', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '81928', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'G. Timothy Kelly, Md', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '73103', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Health Research Of Oklahoma', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19152', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Arthritis Group', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '38305', 'city': 'Jackson', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Arthritis Clinic', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Walter F Chase Md', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Tacoma Center For Arthritis Research Ps', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '1426', 'city': 'Buenos Aires', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Local Institution'}, {'zip': '1431', 'city': 'Capital Federal', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Local Institution'}, {'zip': 'C1034ACO', 'city': 'Ciudad Autonoma de Buenos Aire', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Local Institution'}, {'zip': '370 01', 'city': 'České Budějovice', 'country': 'Czechia', 'facility': 'Local Institution', 'geoPoint': {'lat': 48.97447, 'lon': 14.47434}}, {'zip': '500 05', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'Local Institution', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '128 50', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Local Institution', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '37170', 'city': 'Chambray-lès-Tours', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 47.33537, 'lon': 0.70286}}, {'zip': '75679', 'city': 'Paris', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '44200', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Local Institution', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '44500', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Local Institution', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '14080', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Local Institution', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '64020', 'city': 'Nuevo León', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Local Institution', 'geoPoint': {'lat': 25.65746, 'lon': -100.15538}}, {'zip': '8000', 'city': 'Culiacán', 'state': 'Sinaloa', 'country': 'Mexico', 'facility': 'Local Institution', 'geoPoint': {'lat': 24.80209, 'lon': -107.39421}}, {'zip': '330-721', 'city': 'Cheonan', 'state': 'Choong Chung Nam-Do', 'country': 'South Korea', 'facility': 'Local Institution', 'geoPoint': {'lat': 36.8065, 'lon': 127.1522}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '15706', 'city': 'Santiago de C.', 'country': 'Spain', 'facility': 'Local Institution'}, {'zip': '48903', 'city': 'Vizcaya', 'country': 'Spain', 'facility': 'Local Institution'}, {'zip': 'B', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Local Institution', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '333', 'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Local Institution', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], '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'}}}}