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

Rheumatoid Arthritis Clinical Trial

— HLAPRPA  

Official title:

Study of HLA Polymorphisms in French West-Indian Patients With Rheumatoid Arthritis : A Case Control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01111357
• Other study ID #: 09/B/02
• Status: Completed
• Phase: N/A
• First received: January 29, 2010
• Last updated: December 20, 2010
• Start date: February 2010
• Est. completion date: August 2010

Study information

• Verified date: April 2010
• Source: Centre Hospitalier Universitaire de Fort-de-France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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)

Locations

Country	Name	City	State
Martinique	Service de rhumatologie CHU de Fort-de-France	Fort-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Fort-de-France

Country where clinical trial is conducted

Martinique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of distribution of HLA alleles in patients and in healthy controls		1 day	Yes
Secondary	The association between the different HLA alleles among French West-Indian RA patients and the autoantibodies production.		1 day	Yes
Secondary	The association between the different HLA alleles among French West-Indian RA patients and the radiological damage.		1 day	Yes
Secondary	The association between the different HLA alleles among French West-Indian RA patients and the response to therapy		1 day	Yes