Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2026-01-23 @ 11:45 PM
Study NCT ID:
NCT02885818
Status:
COMPLETED
Last Update Posted:
2019-04-19
First Post:
2016-08-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Abatacept Induce Regulatory B Cells in Patients With 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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-01-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-18', 'studyFirstSubmitDate': '2016-08-22', 'studyFirstSubmitQcDate': '2016-08-31', 'lastUpdatePostDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peripheral blood B-cell phenotype changes', 'timeFrame': '3 months', 'description': 'Measure of the proportion of the main B-cell subsets (transitional, naïve, memory, plasmablasts) by FACS analysis before abatacept initiation and 3 months later.'}], 'secondaryOutcomes': [{'measure': 'In vitro B-cell function and regulatory properties', 'timeFrame': '3 months', 'description': 'In vitro culture of B cells from the patients to assess B cell inhibition of T cell proliferation before abatacept initiation and 3 months later.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'Abatacept disrupts T-cell coactivation signals in rheumatoid arthritis (RA). Its potential effects on B cells are not well described. This study will assess the effects of abatacept therapy on the phenotype and function of peripheral blood B cells in patients with RA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with RA fulfilling ACR/EULAR criteria, in whom abatacept is started as part of their usual clinical care', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* RA as defined by ACR/EULAR criteria\n* Clinical indication to start abatacept therapy\n\nExclusion Criteria:\n\n* Treatment by rituximab in the previous year'}, 'identificationModule': {'nctId': 'NCT02885818', 'acronym': 'ABATACEPT_B', 'briefTitle': 'Does Abatacept Induce Regulatory B Cells in Patients With Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Does Abatacept Induce Regulatory B Cells in Patients With Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'ABATACEPT AND B CELL'}}, 'contactsLocationsModule': {'locations': [{'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'CHRU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}], 'overallOfficials': [{'name': 'Jacques-Olivier Pers', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CHRU de Brest'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}