Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:27 AM
Study NCT ID:
NCT00279760
Status:
COMPLETED
Last Update Posted:
2016-09-16
First Post:
2006-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I/II Multiple-Dose LEA29Y vs CTLAG4Ig vs Placebo in 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': 'D000069594', 'term': 'Abatacept'}], 'ancestors': [{'id': 'D018796', 'term': 'Immunoconjugates'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'lastUpdateSubmitDate': '2016-09-15', 'studyFirstSubmitDate': '2006-01-18', 'studyFirstSubmitQcDate': '2006-01-18', 'lastUpdatePostDateStruct': {'date': '2016-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the relative safety and preliminary efficacy (clinical activity) of BMS-188667 and BMS-224818 in subjects with rheumatoid arthritis (RA)'}], 'secondaryOutcomes': [{'measure': 'Assess the immunogenicity of BMS-188667 and BMS-224818 in subjects with RA, and in a site specific substudy to the protocol, the pharmacokinetics (PK) and pharmacodynamics (PD) of BMS-188667 and BMS-224818 in subjects with RA'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This randomized, double-blind, placebo controlled, parallel and multiple dose study provided safety, preliminary efficacy, and immunogenicity information about the use of BMS-188667 and BMS-224818 in subjects with RA'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of RA \\< 5 years\n* Functional class I, II, or II as defined by the American College of Rheumatology (ACR) criteria.\n* Must have failed at least 1 Disease Modifying Anit-Rheumatic Drug (DMARD)\n* Joint count of 10 or more swollen and 12 or more tender.\n* Erythrocyte Sedimentation Rate (ESR) \\> - 28mm/rr or norning stiffness \\> - 45 minutes.\n\nExclusion Criteria:\n\n* Women and men who are not willing to use an accepted form of contraception.\n* Active vasculitis\n* Treatment with another investigational drug within 30 days\n* History of asthma, angioedema, or anaphylaxix'}, 'identificationModule': {'nctId': 'NCT00279760', 'briefTitle': 'Phase I/II Multiple-Dose LEA29Y vs CTLAG4Ig vs Placebo in Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Pilot, Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Preliminary Clinical Activity and Immunogenicity of Multiple Doses of LEA29Y and CTLA4Ig Administered Intravenously to Subjects With Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'IM103-002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Belatacept', 'type': 'DRUG'}, {'name': 'Abatacept', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Duluth', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 46.78327, 'lon': -92.10658}}, {'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Local Instiution', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Diepenbeek', 'country': 'Belgium', 'facility': 'Local Institution', 'geoPoint': {'lat': 50.90769, 'lon': 5.41875}}, {'city': 'Ghent', 'country': 'Belgium', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Liège', 'country': 'Belgium', 'facility': 'Local Institution', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Mons', 'country': 'Belgium', 'facility': 'Local Institution', 'geoPoint': {'lat': 50.45413, 'lon': 3.95229}}, {'city': 'Pellenberg', 'country': 'Belgium', 'facility': 'Local Institution', 'geoPoint': {'lat': 50.87245, 'lon': 4.79394}}, {'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'city': 'Calgary', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Local Institution'}, {'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Sherbrook', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Local Institution'}, {'city': 'Ste-Foy', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Local Institution'}, {'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}, {'city': 'Lille', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Paris', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Rennes', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Strasbourg', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Erlangen', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'city': 'Fankfurt', 'country': 'Germany', 'facility': 'Local Institution'}, {'city': 'Hanover', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Leipzig', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'München', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Münster', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'city': 'Ratingen', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.29724, 'lon': 6.84929}}, {'city': 'Cork', 'country': 'Ireland', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.89797, 'lon': -8.47061}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': 'Local Institution', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Local Institution', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Local Institution', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Bern', 'country': 'Switzerland', 'facility': 'Local Institution', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Local Institution', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Local Institution', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Local Institution', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}}}}