Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-27 @ 1:01 PM
Study NCT ID:
NCT01357668
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-25
First Post:
2011-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Belgium']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001171', 'term': 'Arthritis, Juvenile'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-01-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2011-05-19', 'studyFirstSubmitQcDate': '2011-05-20', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-01-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence rate of serious infections', 'timeFrame': '10 years'}, {'measure': 'Incidence rate of malignancies', 'timeFrame': '10 years'}, {'measure': 'Incidence rate of autoimmune disorders', 'timeFrame': '10 years'}], 'secondaryOutcomes': [{'measure': 'Number of serious adverse events', 'timeFrame': '10 years'}, {'measure': 'Number of targeted infections (Epstein-Barr virus, cytomegalovirus, papilloma virus, herpes zoster, tuberculosis and opportunistic infections)', 'timeFrame': '10 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Juvenile Idiopathic Arthritis']}, 'referencesModule': {'references': [{'pmid': '38243722', 'type': 'DERIVED', 'citation': 'Lovell DJ, Tzaribachev N, Henrickson M, Simonini G, Griffin TA, Alexeeva E, Bohnsack JF, Zeft A, Horneff G, Vehe RK, Stanevica V, Tarvin S, Trachana M, Del Rio AQ, Huber AM, Kietz D, Orban I, Dare J, Foeldvari I, Quartier P, Dominique A, Simon TA, Martini A, Brunner HI, Ruperto N; for PRINTO and the Pediatric Rheumatology Collaborative Study Group (PRCSG) section sign. Safety and effectiveness of abatacept in juvenile idiopathic arthritis: results from the PRINTO/PRCSG registry. Rheumatology (Oxford). 2024 Sep 1;63(SI2):SI195-SI206. doi: 10.1093/rheumatology/keae025.'}], 'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the long-term safety of Abatacept for the treatment of juvenile idiopathic arthritis (JIA) with particular in interest in the occurrence of serious infections, autoimmune disorders, and malignancies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric rheumatology clinics', 'healthyVolunteers': False, 'eligibilityCriteria': "For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria\n\n* Diagnosis of JIA (any subtype)\n* Age \\< 18 years at the time of enrollment unless currently or previously enrolled in an abatacept clinical trial and received abatacept\n* Receiving Abatacept at the time of enrollment as per treating physician's decision or received abatacept in a clinical trial\n* Parent or legally acceptable representative willing to participate in the study and sign the informed consent\n\nExclusion Criteria\n\n* Pregnant or nursing female at the time of enrollment\n* Prior malignancies if the patient has not been malignancy free for at least 5 years.\n* Any serious acute or chronic medical condition other than JIA, including chronic infection, which would compromise the patient's ability to participate in the study\n* Known poor compliance with clinic visits (based on physician judgment)."}, 'identificationModule': {'nctId': 'NCT01357668', 'briefTitle': 'An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis', 'orgStudyIdInfo': {'id': 'IM101-240'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with JIA who are treated with Abatacept', 'description': "Patients with JIA who are treated with Abatacept according to physicians'/families' decisions"}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Local Institution - 0060', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '08540', 'city': 'Princeton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Local Institution - 0001', 'geoPoint': {'lat': 40.34872, 'lon': -74.65905}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Local Institution - 0059', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '0', 'city': 'Bregenz', 'country': 'Austria', 'facility': 'Local Institution - 0025', 'geoPoint': {'lat': 47.50311, 'lon': 9.7471}}, {'zip': 'A-6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Local Institution - 0002', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '1160', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Local Institution - 0032', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '18618-970', 'city': 'Botucatu', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Local Institution - 0010', 'geoPoint': {'lat': -22.88583, 'lon': -48.445}}, {'zip': '13083-888', 'city': 'Campinas', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Local Institution - 0026', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}, {'zip': '04023-061', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Local Institution - 0028', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '22250-110', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Local Institution - 0027', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': 'T3B 6A8', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Local Institution - 0029', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'H4A 3J1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Local Institution - 0011', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '8200', 'city': 'Aarhus', 'state': 'Central Jutland', 'country': 'Denmark', 'facility': 'Local Institution - 0035', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Local Institution - 0012', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '63000', 'city': 'Clermont-Ferrand', 'state': 'Puy-de-Dôme', 'country': 'France', 'facility': 'Local Institution - 0040', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '75743', 'city': 'Paris', 'country': 'France', 'facility': 'Local Institution - 0005', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Local Institution - 0041', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '24576', 'city': 'Bad Bramstedt', 'country': 'Germany', 'facility': 'Local Institution - 0003', 'geoPoint': {'lat': 53.91827, 'lon': 9.88243}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Local Institution - 0030', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Local Institution - 0034', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '22391', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Local Institution - 0031', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Local Institution - 0033', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '54642', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Local Institution - 0016', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': 'H-1023', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Local Institution - 0017', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '91031', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Local Institution - 0014', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '50139', 'city': 'Florence', 'country': 'Italy', 'facility': 'Local Institution - 0042', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '16147', 'city': 'Genova', 'country': 'Italy', 'facility': 'Local Institution - 0015', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '80131', 'city': 'Naples', 'country': 'Italy', 'facility': 'Local Institution - 0043', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}, {'zip': '80138', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Local Institution - 0045', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '35128', 'city': 'Padua', 'country': 'Italy', 'facility': 'Local Institution - 0044', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '38100', 'city': 'Trento', 'country': 'Italy', 'facility': 'Local Institution - 0046', 'geoPoint': {'lat': 46.06787, 'lon': 11.12108}}, {'zip': 'LV-1007', 'city': 'Riga', 'country': 'Latvia', 'facility': 'Local Institution - 0018', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': '44620', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Local Institution - 0006', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '3015 CE', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Local Institution - 0047', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '3584 EA', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Local Institution - 0019', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '9019', 'city': 'Tromsø', 'country': 'Norway', 'facility': 'Local Institution - 0048', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}, {'zip': '7006', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'Local Institution - 0049', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}, {'zip': '1', 'city': 'Lima', 'country': 'Peru', 'facility': 'Local Institution - 0007', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': 'LIMA 14', 'city': 'Lima', 'country': 'Peru', 'facility': 'Local Institution - 0050', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '1600', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Local Institution - 0020', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': 'PR 960', 'city': 'Bayamón', 'country': 'Puerto Rico', 'facility': 'Local Institution - 0023', 'geoPoint': {'lat': 18.39856, 'lon': -66.15572}}, {'zip': 'PR 960', 'city': 'Bayamón', 'country': 'Puerto Rico', 'facility': 'Local Institution - 0056', 'geoPoint': {'lat': 18.39856, 'lon': -66.15572}}, {'zip': '0', 'city': 'Cluj-Napoca', 'country': 'Romania', 'facility': 'Local Institution - 0021', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'zip': '115522', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Local Institution - 0051', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '119991', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Local Institution', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '194100', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Local Institution - 0053', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '410054', 'city': 'Saratov', 'country': 'Russia', 'facility': 'Local Institution - 0052', 'geoPoint': {'lat': 51.54048, 'lon': 45.9901}}, {'zip': '21159', 'city': 'Jeddah', 'country': 'Saudi Arabia', 'facility': 'Local Institution - 0055', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}, {'zip': '11426', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'Local Institution - 0024', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'zip': '0', 'city': 'Piešťany', 'country': 'Slovakia', 'facility': 'Local Institution - 0022', 'geoPoint': {'lat': 48.59479, 'lon': 17.82591}}, {'zip': '0002', 'city': 'Pretoria', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Local Institution - 0009', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '7500', 'city': 'Panorama, Cape Town', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Local Institution - 0057', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '0084', 'city': 'Pretoria', 'country': 'South Africa', 'facility': 'Local Institution - 0058', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '08970', 'city': 'Sant Joan Despí', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Local Institution - 0036', 'geoPoint': {'lat': 41.36718, 'lon': 2.0574}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Local Institution - 0004', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Local Institution - 0038', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '30120', 'city': 'Murcia', 'country': 'Spain', 'facility': 'Local Institution - 0037', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'zip': '46009', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Local Institution - 0039', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': 'BS2 8BJ', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Local Institution - 0013', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}