NCT01111357

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2010

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 27, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

December 21, 2010

Status Verified

April 1, 2010

Enrollment Period

6 months

First QC Date

January 29, 2010

Last Update Submit

December 20, 2010

Conditions

Keywords

Rheumatoid ArthritisRheumatoid Arthritis according to ACR criteria of diagnosis

Outcome Measures

Primary Outcomes (1)

  • Difference of distribution of HLA alleles in patients and in healthy controls

    1 day

Secondary Outcomes (3)

  • The association between the different HLA alleles among French West-Indian RA patients and the autoantibodies production.

    1 day

  • The association between the different HLA alleles among French West-Indian RA patients and the radiological damage.

    1 day

  • The association between the different HLA alleles among French West-Indian RA patients and the response to therapy

    1 day

Interventions

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)

Also known as: Rheumatoid Arthritis, French West-Indian Patients with Rheumatoid Arthritis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Residents of Martinique with at least 3 African-Caribbean grandparents

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de rhumatologie CHU de Fort-de-France

Fort-de-France, 97261, Martinique

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood : collect of 10 ml of peripheric blood

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Georges JEAN-BAPTISTE, Professor of medecine

    CHU de Fort-de-France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 29, 2010

First Posted

April 27, 2010

Study Start

February 1, 2010

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

December 21, 2010

Record last verified: 2010-04

Locations