Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2026-01-06 @ 1:27 PM
Study NCT ID:
NCT03769558
Status:
COMPLETED
Last Update Posted:
2020-03-20
First Post:
2018-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Juvenile Idiopathic Arthritis Patients Given Abatacept and the Number of Infections or Malignancies That Occur
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 264}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2016-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-19', 'studyFirstSubmitDate': '2018-12-06', 'studyFirstSubmitQcDate': '2018-12-06', 'lastUpdatePostDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of infections', 'timeFrame': '110 months'}], 'secondaryOutcomes': [{'measure': 'Incidence of malignancies', 'timeFrame': '110 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Juvenile Idiopathic Arthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html', 'label': 'Investigator Inquiry Form'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'This study will determine the incidences of infections and malignancies among JIA patients treated with abatacept'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include all patients with JIA who are treated with abatacept', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Two diagnoses of JIA (ICD-9 code 714.3x) within 90 days\n* Age less than 18 years at the time of second of the two diagnoses\n* Index date is the date of initiating treatment with abatacept\n\nExclusion Criteria:\n\n* Greater than or equal to 18 years of age'}, 'identificationModule': {'nctId': 'NCT03769558', 'briefTitle': 'A Study of Juvenile Idiopathic Arthritis Patients Given Abatacept and the Number of Infections or Malignancies That Occur', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Supplemental Data for the Juvenile Idiopathic Arthritis FDA Written Request', 'orgStudyIdInfo': {'id': 'IM101-643'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'JIA patients prescribed abatacept', 'interventionNames': ['Other: Non-Interventional']}], 'interventions': [{'name': 'Non-Interventional', 'type': 'OTHER', 'description': 'Non-Interventional', 'armGroupLabels': ['JIA patients prescribed abatacept']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08540', 'city': 'Princeton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.34872, 'lon': -74.65905}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}