- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01111357
Study of Human Leukocyte Antigen (HLA) Polymorphisms in Patients With Rheumatoid Arthritis (HLAPRPA)
December 20, 2010 updated by: University Hospital Center of Martinique
Study of HLA Polymorphisms in French West-Indian Patients With Rheumatoid Arthritis : A Case Control Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Fort-de-France, Martinique, 97261
- Service de rhumatologie CHU de Fort-de-France
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Residents of Martinique with at least 3 African-Caribbean grandparents
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Difference of distribution of HLA alleles in patients and in healthy controls
Time Frame: 1 day
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The association between the different HLA alleles among French West-Indian RA patients and the autoantibodies production.
Time Frame: 1 day
|
1 day
|
|
The association between the different HLA alleles among French West-Indian RA patients and the radiological damage.
Time Frame: 1 day
|
1 day
|
|
The association between the different HLA alleles among French West-Indian RA patients and the response to therapy
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Georges JEAN-BAPTISTE, Professor of medecine, CHU de Fort-de-France
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
January 29, 2010
First Submitted That Met QC Criteria
April 23, 2010
First Posted (Estimate)
April 27, 2010
Study Record Updates
Last Update Posted (Estimate)
December 21, 2010
Last Update Submitted That Met QC Criteria
December 20, 2010
Last Verified
April 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09/B/02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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