Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-25 @ 5:15 PM
Study NCT ID:
NCT00034203
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2002-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of a Monoclonal Antibody for Treatment of 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': 'C472181', 'term': 'efalizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-04'}, 'statusVerifiedDate': '2004-09', 'completionDateStruct': {'date': '2003-08'}, 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '2002-04-23', 'studyFirstSubmitQcDate': '2002-04-24', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-04-25', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a humanized monoclonal antibody (efalizumab) is safe and effective in the treatment of rheumatoid arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Clinical diagnosis of moderate to severe rheumatoid arthritis.\n* On stable dose of methotrexate.\n* 18 to 80 years of age.\n* Less than 275 lbs.\n\nExclusion criteria:\n\n* Joint replacement surgery within 60 days of the start of drug dosing.\n* Intra-articular cortisone injections within 28 days of the start of drug dosing.\n* Pregnancy.\n* History of severe allergic or anaphylactic reactions.\n* Active bacterial, viral, fungal, mycobacterium tuberculosis.\n* Positive PPD test.\n* History of any opportunistic infection.\n* Serious persisting local or systemic infection.\n* History of malignancy within the past five years.\n* Received any vaccine within 28 days of the start of study drug dosing.\n* Joint replacement therapy planned within nine months of the start of study drug dosing.\n* Chronic disorders apart from RA affecting the joints.\n* Significant systemic involvement secondary to RA.\n* COPD, asthma, or other pulmonary disease.\n* Received any DMARD other than methotrexate in the 28 days prior to the start of study drug dosing.\n* Approved biologic RA therapy during the 28 days or 7 half-lives of the drug prior to the start of drug dosing.\n* Investigational drug and/or treatment during the 28 days or seven half-lives of the investigational drug prior to the start of study drug dosing.\n* Liver disease or abnormal hepatic function.\n* Serum creatinine level \\> 1.5 mg/dL.\n* Platelet count \\< 125,000 cells/mm3.\n* WBC count \\< 3,500 cells/mm3.\n* Seropositive for hepatitis B surface antigen.\n* Seropositive for hepatitis C antibody.\n* Known seropositivity for HIV.'}, 'identificationModule': {'nctId': 'NCT00034203', 'briefTitle': 'Safety and Efficacy of a Monoclonal Antibody for Treatment of Rheumatoid Arthritis.', 'organization': {'class': 'INDUSTRY', 'fullName': 'XOMA (US) LLC'}, 'orgStudyIdInfo': {'id': 'HURA501'}}, 'armsInterventionsModule': {'interventions': [{'name': 'efalizumab', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Rheumatology Associates of North Alabama', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85253', 'city': 'Paradise Valley', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Arthritis Research, PLC', 'geoPoint': {'lat': 33.53115, 'lon': -111.94265}}, {'zip': '85715', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Advanced Clinical Therapeutics, LLC', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'NEA Clinic', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Little Rock Diagnostic Clinic', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92093-0943', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California at San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Wallace Rheumatic Study Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91730', 'city': 'Rancho Cucamonga', 'state': 'California', 'country': 'United States', 'facility': 'Boling Clinical Trials', 'geoPoint': {'lat': 34.1064, 'lon': -117.59311}}, {'zip': '92270', 'city': 'Rancho Mirage', 'state': 'California', 'country': 'United States', 'facility': 'Desert Medical Advances', 'geoPoint': {'lat': 33.73974, 'lon': -116.41279}}, {'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'The San Diego Arthritis and Osteoporosis Medical Clinic', 'geoPoint': {'lat': 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{'zip': '02720', 'city': 'Fall River', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Phase III Clinical Research', 'geoPoint': {'lat': 41.70149, 'lon': -71.15505}}, {'zip': '64114', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'The Center for Pharmaceutical Research', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University Center for Clinical Studies', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89128', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Clinical Research Center of Nevada', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'State University of New York Health Science Center at Brooklyn', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '13326', 'city': 'Cooperstown', 'state': 'New York', 'country': 'United States', 'facility': 'Bassett Healthcare Clinical Pharmacology Research Center', 'geoPoint': {'lat': 42.70048, 'lon': -74.92426}}, {'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'Long Island Jewish Medical Center', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Joint Disease, ACRC', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11803', 'city': 'Plainview', 'state': 'New York', 'country': 'United States', 'facility': 'Prem C. 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