Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-02 @ 5:15 AM
Study NCT ID:
NCT00049751
Status:
COMPLETED
Last Update Posted:
2006-08-15
First Post:
2002-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects 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': 'D000068879', 'term': 'Adalimumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 3000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-09'}, 'statusVerifiedDate': '2006-08', 'lastUpdateSubmitDate': '2006-08-13', 'studyFirstSubmitDate': '2002-11-13', 'studyFirstSubmitQcDate': '2002-11-13', 'lastUpdatePostDateStruct': {'date': '2006-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-11-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in disease activity score at visit week 12 as compared to baseline'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '27338778', 'type': 'DERIVED', 'citation': 'Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate safety by collecting serious adverse events in subjects with moderately to severely active rheumatoid arthritis who are unable to obtain etanercept and who have failed one or more prior disease-modifying antirheumatic drugs (DMARDs).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion:\n\n* Subjects must meet ACR criteria for diagnosis of RA for at least 3 months, must meet ACR Functional Class I, II or III (1992 criteria) and must have a confirmed diagnosis of active moderate to severe rheumatoid arthritis as defined by 6 or more swollen joints and 9 or more tender joints;\n* must also have DAS of 3.2 or greater at study entry,\n* normal laboratory parameters and ESR \\>20,\n* satisfactory response or intolerance to one or more prior DMARDs and\n* be willing and able to give informed consent.\n\nExclusion:\n\n* Previous treatment with total lymphoid irradiation or anti-CD4 or CAMPATH 1H monoclonal antibodies resulting in persistent CD4 lymphopenia,\n* history of acute inflammatory joint disease other than RA,\n* prior treatment with cyclophosphamide or chlorambucil,\n* prior treatment with intravenous immunoglobulin within 70 days,\n* history of malignant lymphoma,\n* history of uncontrolled diabetes,\n* unstable ischemic heart disease,\n* active inflammatory bowel disease,\n* active peptic ulcer disease or stroke,\n* positive HIV status,\n* positive serology for Hepatitis B or C,\n* no previous history of tuberculosis or listeria infection,\n* no previous history of cancer other than successfully treated skin cancer;\n* women can not be pregnant or be breastfeeding'}, 'identificationModule': {'nctId': 'NCT00049751', 'briefTitle': 'Study of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects With Active Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'A Multicenter Study of the Safety of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects With Active Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'M02-498'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Adalimumab', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Thomas McGee, MD', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'city': 'Apple Valley', 'state': 'California', 'country': 'United States', 'facility': 'Desert Valley Medical', 'geoPoint': {'lat': 34.50083, 'lon': -117.18588}}, {'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Kenneth Hsu, MD, Inc.', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Rheumatology Clinic', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Napa', 'state': 'California', 'country': 'United States', 'facility': 'Michael Harrington, MD', 'geoPoint': {'lat': 38.29714, 'lon': -122.28553}}, {'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Midori Jane Nishio, MD', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'Naveen Raja, MD', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Mountain Rheumatology', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Division of Rheumatic Diseases/University of CT Health Center', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'New Haven Medical Group, PC', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'Norman Gaylis, MD', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Mike Schweitz, MD', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'city': 'Winter Haven', 'state': 'Florida', 'country': 'United States', 'facility': 'Maurice McCarthy, MD', 'geoPoint': {'lat': 28.02224, 'lon': -81.73286}}, {'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Intermountain Orthopedics', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Institute of Arthritis Research', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loyola University Medical Center', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'city': 'Oak Park', 'state': 'Illinois', 'country': 'United States', 'facility': 'West Suburban Health Care', 'geoPoint': {'lat': 41.88503, 'lon': -87.7845}}, {'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'OSF Medical Group -Rheumatology', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'city': 'Rockton', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rockford Clinic, Clinical Research Department', 'geoPoint': {'lat': 42.45252, 'lon': -89.07233}}, {'city': 'Schaumburg', 'state': 'Illinois', 'country': 'United States', 'facility': 'Pain Therapy Center', 'geoPoint': {'lat': 42.03336, 'lon': -88.08341}}, {'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Baton Rouge Clinic', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Thomas Pressly, MD', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'city': 'Portland', 'state': 'Maine', 'country': 'United States', 'facility': 'Rheumatology Associates', 'geoPoint': {'lat': 43.65737, 'lon': -70.2589}}, {'city': 'Northampton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Northampton Internal Medicine Association', 'geoPoint': {'lat': 42.32509, 'lon': -72.6412}}, {'city': 'West Boylston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Fallon Clinic Research', 'geoPoint': {'lat': 42.36676, 'lon': -71.78563}}, {'city': 'Bay City', 'state': 'Michigan', 'country': 'United States', 'facility': 'John Howland, MD', 'geoPoint': {'lat': 43.59447, 'lon': -83.88886}}, {'city': 'Joplin', 'state': 'Missouri', 'country': 'United States', 'facility': 'Freeman Health Systems', 'geoPoint': {'lat': 37.08423, 'lon': -94.51328}}, {'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': 'Peggy Schlesinger, MD', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'city': 'Fair Lawn', 'state': 'New Jersey', 'country': 'United States', 'facility': 'NJ Associates in Medicine', 'geoPoint': {'lat': 40.94038, 'lon': -74.13181}}, {'city': 'Millburn', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Internal Medicine and Rheumatic Diseases', 'geoPoint': {'lat': 40.72482, 'lon': -74.30404}}, {'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Placido Morano, MD', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Hospital for Joint Disease', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Port Jefferson Station', 'state': 'New York', 'country': 'United States', 'facility': 'Alan Kaell, MD', 'geoPoint': {'lat': 40.92538, 'lon': -73.04733}}, {'city': 'Monroe', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Bone and Joint, PA', 'geoPoint': {'lat': 34.98543, 'lon': -80.54951}}, {'city': 'Salisbury', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Gordon Senter, MD Rheumatology, PA', 'geoPoint': {'lat': 35.67097, 'lon': -80.47423}}, {'city': 'Bismarck', 'state': 'North Dakota', 'country': 'United States', 'facility': 'MedCenter One Health Systems', 'geoPoint': {'lat': 46.80833, 'lon': -100.78374}}, {'city': 'Beachwood', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospital of Cleveland', 'geoPoint': {'lat': 41.4645, 'lon': -81.50873}}, {'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Arthritis Clinic', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'STAT Research, Inc.', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'city': 'Bend', 'state': 'Oregon', 'country': 'United States', 'facility': 'Arthritis and Osteoporosis Clinic, LLC', 'geoPoint': {'lat': 44.05817, 'lon': -121.31531}}, {'city': 'Bend', 'state': 'Oregon', 'country': 'United States', 'facility': 'Jel M. Depper, MD', 'geoPoint': {'lat': 44.05817, 'lon': -121.31531}}, {'city': 'Camp Hill', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Sanford and Roumm Rheumatology', 'geoPoint': {'lat': 40.23981, 'lon': -76.91997}}, {'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Frederick Murphy, MD', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'city': 'Norristown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Rheumatology Associates', 'geoPoint': {'lat': 40.1215, 'lon': -75.3399}}, {'city': 'Sellersville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Rheumatology Associates, Ltd.', 'geoPoint': {'lat': 40.35399, 'lon': -75.3049}}, {'city': 'North Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Low Country Research Center', 'geoPoint': {'lat': 32.85462, 'lon': -79.97481}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Medical Specialists of Nashville', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'Waco', 'state': 'Texas', 'country': 'United States', 'facility': 'Arthritis and Osteoporosis Clinical Research Center of Central Texas', 'geoPoint': {'lat': 31.54933, 'lon': -97.14667}}, {'city': 'Chesapeake', 'state': 'Virginia', 'country': 'United States', 'facility': 'Center of Arthritis and Rheumatic Disease, PC', 'geoPoint': {'lat': 36.81904, 'lon': -76.27494}}, {'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Margaret Gradzka, MD', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Metropolitan Clinical Research', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}, {'city': 'Reston', 'state': 'Virginia', 'country': 'United States', 'facility': 'Northern Virginia Center for Arthritis', 'geoPoint': {'lat': 38.96872, 'lon': -77.3411}}, {'city': 'Salem', 'state': 'Virginia', 'country': 'United States', 'facility': 'Lewis-Gale Clinic', 'geoPoint': {'lat': 37.29347, 'lon': -80.05476}}, {'city': 'Lakewood', 'state': 'Washington', 'country': 'United States', 'facility': 'ROAD Clinic', 'geoPoint': {'lat': 47.17176, 'lon': -122.51846}}], 'overallOfficials': [{'name': 'William M. Edwards, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Low Country Research Center, North Charelston SC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}}}}