Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-27 @ 5:11 PM
Study NCT ID:
NCT01111357
Status:
COMPLETED
Last Update Posted:
2010-12-21
First Post:
2010-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Human Leukocyte Antigen (HLA) Polymorphisms 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_WITH_DNA', 'description': 'whole blood : collect of 10 ml of peripheric blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-20', 'studyFirstSubmitDate': '2010-01-29', 'studyFirstSubmitQcDate': '2010-04-23', 'lastUpdatePostDateStruct': {'date': '2010-12-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference of distribution of HLA alleles in patients and in healthy controls', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'The association between the different HLA alleles among French West-Indian RA patients and the autoantibodies production.', 'timeFrame': '1 day'}, {'measure': 'The association between the different HLA alleles among French West-Indian RA patients and the radiological damage.', 'timeFrame': '1 day'}, {'measure': 'The association between the different HLA alleles among French West-Indian RA patients and the response to therapy', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis', 'Rheumatoid Arthritis according to ACR criteria of diagnosis'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'Rheumatoid arthritis (RA), affects between 0.3% and 1.0% of the population, it can lead to progressive joint destruction and severe disability. To date, two RA genetic susceptibility factors have been identified: HLA-DRB1-SE (Shared epitope) and PTPN22 620W alleles. The predictive value of the alleles for diagnosis of RA was previously investigated in cohorts of caucasians patients with early unclassified arthritis that showed restrained association between RA and HLA-SE. Despite the contribution of HLA to the overall genetic risk has been estimated to range from 30% to 50%, it has never been studied in the French west-Indian population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Residents of Martinique with at least 3 African-Caribbean grandparents', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Rheumatoid Arthritis according to ACR criteria\n* Come from French West Indies (At least 3 grandparents are African-Caribbean)\n* Sign written informed consent\n\nExclusion Criteria:\n\n* Minor\n* Patient with no Rheumatoid Arthritis according to ACR criteria\n* Patient does not agree for a genetic study\n\nFor the control\n\nInclusion Criteria:\n\n* Blood donor\n* Sign written informed consent\n* Patient with no Rheumatoid Arthritis according to ACR criteria\n* Come from French West Indies (At least 3 grandparents are African-Caribbean)\n\nExclusion Criteria:\n\n* Minor\n* Patient does not agree for a genetic study'}, 'identificationModule': {'nctId': 'NCT01111357', 'acronym': 'HLAPRPA', 'briefTitle': 'Study of Human Leukocyte Antigen (HLA) Polymorphisms in Patients With Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Center of Martinique'}, 'officialTitle': 'Study of HLA Polymorphisms in French West-Indian Patients With Rheumatoid Arthritis : A Case Control Study', 'orgStudyIdInfo': {'id': '09/B/02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Collect of 10 ml of peripheric blood for DNA extraction', 'type': 'BIOLOGICAL', 'otherNames': ['Rheumatoid Arthritis', 'French West-Indian Patients with Rheumatoid Arthritis'], 'description': 'After signed written consent, all patients have a clinic exam in order to assess the presence of eligibility criteria (Patient with Rheumatoid Arthritis that fulfil the ACR criteria of diagnosis)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '97261', 'city': 'Fort-de-France', 'country': 'Martinique', 'facility': 'Service de rhumatologie CHU de Fort-de-France', 'geoPoint': {'lat': 14.60365, 'lon': -61.07418}}], 'overallOfficials': [{'name': 'Georges JEAN-BAPTISTE, Professor of medecine', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Fort-de-France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Center of Martinique', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'JEAN - BAPTISTE Georges', 'oldOrganization': 'Service de Rhumathologie CHU de Fort-de-France'}}}}