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Trial record 2 of 2366 for:    Rheumatoid Arthritis

Study of Human Leukocyte Antigen (HLA) Polymorphisms in Patients With Rheumatoid Arthritis (HLAPRPA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01111357
First Posted: April 27, 2010
Last Update Posted: December 21, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital Center of Martinique
  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:


Further study details as provided by University Hospital Center of Martinique:

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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01111357


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

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
First Submitted: January 29, 2010
First Posted: April 27, 2010
Last Update Posted: December 21, 2010
Last Verified: April 2010

Keywords provided by University Hospital Center of Martinique:
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