Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-02-03 @ 4:37 AM
Study NCT ID:
NCT00639834
Status:
COMPLETED
Last Update Posted:
2013-05-22
First Post:
2008-01-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Safety of MDX-1342 in Combination With Methotrexate in Patients With Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Poland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D001168', 'term': 'Arthritis'}], 'ancestors': [{'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': 'C557496', 'term': 'MDX-1342 antibody'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-21', 'studyFirstSubmitDate': '2008-01-10', 'studyFirstSubmitQcDate': '2008-03-19', 'lastUpdatePostDateStruct': {'date': '2013-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence and severity of treatment-emergent adverse events', 'timeFrame': 'all adverse events will be followed to resolution'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['rheumatoid', 'arthritis', 'RA', 'joint inflammation', 'autoimmune', 'Medarex', 'Rheumatology'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine if MDX-1342 given in combination with Methotrexate is a safe treatment for patients with active rheumatoid arthritis. In addition, changes in the severity patients' arthritis will also be analysed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have met ACR criteria for the diagnosis of rheumatoid arthritis (RA)\n* Must have active RA\n* Must be treated with Methotrexate (MTX) (10 to 25 mg weekly) for at least 3 months and have received a stable dose for at least 28 days prior to the anticipated study drug administration date.\n* All other DMARDs or biologics must be discontinued at least 28 days prior to study drug administration and: 1) Leflunomide, which must be discontinued at least 60 days before study drug administration, 2) infliximab, adalimumab, and abatacept must be discontinued at least 56 days prior to study drug administration\n\nExclusion Criteria:\n\n* Both Rheumatoid factor and anti-CCP negative\n* Prior treatment with any B-cell depleting therapy\n* Any other mAb or Ig-based fusion proteins 56 days or less prior to Visit\n* History of or current inflammatory joint disease other than RA\n* Neuropathies or neurovasculopathies that might interfere with pain evaluation\n* Complications of RA or other disease\n* Any other autoimmune disease other than RA\n* Acute or chronic infection\n* Clinically significant disease requiring'}, 'identificationModule': {'nctId': 'NCT00639834', 'acronym': 'MDX1342-01', 'briefTitle': 'Study of the Safety of MDX-1342 in Combination With Methotrexate in Patients With Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1, Multicenter, Single-dose, Dose-escalation, Safety and Tolerability Study of MDX-1342 (Anti-CD19 Human Monoclonal Antibody) in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'MDX1342-01'}, 'secondaryIdInfos': [{'id': 'IM130-001', 'type': 'OTHER', 'domain': 'BMS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Active MDX-1342 given in combination with Methotrexate', 'interventionNames': ['Biological: MDX-1342']}], 'interventions': [{'name': 'MDX-1342', 'type': 'BIOLOGICAL', 'description': 'One dose of active MDX-1342 (anti-CD19 fully human monoclonal antibody) will be administered to patients as an i.v. infusion. Patients will receive one dose of MDX-1342 given in combination with Methotrexate treatment.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'Sun Valley Arthritis Center LTD.', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '90036', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Impact Clinical Trials', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33334', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Centre for Rheumatology, Immunology and Arthritis (CRIA)', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32127', 'city': 'Port Orange', 'state': 'Florida', 'country': 'United States', 'facility': 'Coastal Medical Research, Inc', 'geoPoint': {'lat': 29.13832, 'lon': -80.99561}}, {'zip': '34233', 'city': 'Venice', 'state': 'Florida', 'country': 'United States', 'facility': 'Lovelace Scientific Resources', 'geoPoint': {'lat': 27.09978, 'lon': -82.45426}}, {'zip': '21239', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Good Samaritan Hospital and Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48910', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Justus Fiechtner', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Altoona Center for Clinical Research', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Arthritis Northwest Rheumatology, PLLC', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'George Krick, MD', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '50924', 'city': 'Cologne', 'country': 'Germany', 'facility': 'klinikum der Universitat zu Koln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Universitatsklinikum "Carl Gustav Carus" an der Technischen Universtitat Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '81675', 'city': 'Munich', 'country': 'Germany', 'facility': 'Klinikum rechts der Isar der TU Munchen', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': 'H-8230', 'city': 'Balatonfüred', 'country': 'Hungary', 'facility': 'DRC Gyógyszervizsgáló Központ Kft', 'geoPoint': {'lat': 46.96188, 'lon': 17.87187}}, {'zip': 'H-1083', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Semmelweis Egyetem Altalanos Orvostudomanyi Kar-I. sz', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': 'H-4012', 'city': 'Debrecen', 'country': 'Hungary', 'facility': 'DEOEC Kinikai Farmakologiai Tanszek', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'city': 'Szeged', 'country': 'Hungary', 'facility': 'First Department of Medicine', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'zip': '83045', 'city': 'Donetsk', 'country': 'Ukraine', 'facility': 'V.K. Gusak Institute of Urgent & Reconstructive Surgery under UAMS, Hospital Therapy and Rehabilitaiton Clinic', 'geoPoint': {'lat': 48.023, 'lon': 37.80224}}, {'zip': '61115', 'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Kharkiv Medical Academy of Postgraduate Education, City Clinical General Hospital #25', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'zip': '69035', 'city': 'Zaporizhya', 'country': 'Ukraine', 'facility': 'Zaporizhya State Medical University, City Clinical Hopsital #6, Therapeutics Department'}, {'zip': '69600', 'city': 'Zaporizhzhya', 'country': 'Ukraine', 'facility': 'Zaporizhzhya Regional Clinical Hospital, Rheumatology Department', 'geoPoint': {'lat': 47.85167, 'lon': 35.11714}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'The Kellgren Centre for Rheumatology', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'Welcome Trust Clinical Research Facility, Southampton General Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}