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Trial record 3 of 3 for:    HLA-DRB1
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Study of Human Leukocyte Antigen (HLA) Polymorphisms in Patients With Rheumatoid Arthritis (HLAPRPA)

This study has been completed.
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Fort-de-France
ClinicalTrials.gov Identifier:
NCT01111357
First received: January 29, 2010
Last updated: December 20, 2010
Last verified: April 2010
History of Changes
  Purpose

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.


Condition Intervention
Rheumatoid Arthritis
 Biological: Collect of 10 ml of peripheric blood for DNA extraction

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Study of HLA Polymorphisms in French West-Indian Patients With Rheumatoid Arthritis : A Case Control Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Fort-de-France:

Primary Outcome Measures:
  • Difference of distribution of HLA alleles in patients and in healthy controls [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The association between the different HLA alleles among French West-Indian RA patients and the autoantibodies production. [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
  • The association between the different HLA alleles among French West-Indian RA patients and the radiological damage. [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
  • The association between the different HLA alleles among French West-Indian RA patients and the response to therapy [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

whole blood : collect of 10 ml of peripheric blood


Estimated Enrollment: 200
Study Start Date: February 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Collect of 10 ml of peripheric blood for DNA extraction
    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)
    Other Names:
    • Rheumatoid Arthritis
    • French West-Indian Patients with Rheumatoid Arthritis
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Residents of Martinique with at least 3 African-Caribbean grandparents

Criteria

Inclusion Criteria:

  • Diagnosis of Rheumatoid Arthritis according to ACR criteria
  • Come from French West Indies (At least 3 grandparents are African-Caribbean)
  • Sign written informed consent

Exclusion Criteria:

  • Minor
  • Patient with no Rheumatoid Arthritis according to ACR criteria
  • Patient does not agree for a genetic study

For the control

Inclusion Criteria:

  • Blood donor
  • Sign written informed consent
  • Patient with no Rheumatoid Arthritis according to ACR criteria
  • Come from French West Indies (At least 3 grandparents are African-Caribbean)

Exclusion Criteria:

  • Minor
  • Patient does not agree for a genetic study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01111357

Locations
Martinique
Service de rhumatologie CHU de Fort-de-France
Fort-de-France, Martinique, 97261
Sponsors and Collaborators
Centre Hospitalier Universitaire de Fort-de-France
Investigators
Principal Investigator: Georges JEAN-BAPTISTE, Professor of medecine CHU de Fort-de-France
  More Information

No publications provided

Responsible Party: JEAN - BAPTISTE Georges, Service de Rhumathologie CHU de Fort-de-France
ClinicalTrials.gov Identifier: NCT01111357     History of Changes
Other Study ID Numbers: 09/B/02
Study First Received: January 29, 2010
Last Updated: December 20, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire de Fort-de-France:
Rheumatoid Arthritis
Rheumatoid Arthritis according to ACR criteria of diagnosis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2013