Rheumatoid ArthritisHLAPRPANCT01111357
Study of Human Leukocyte Antigen (HLA) Polymorphisms in Patients With Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by University Hospital Center of Martinique at 1 site in Martinique.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Collect of 10 ml of peripheric blood for DNA extraction
- How many people
- 200 participants
- Where
- 1 siteMartinique
- Study dates
- Feb 2010to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Residents of Martinique with at least 3 African-Caribbean grandparents
Who may be able to join
- Diagnosis of Rheumatoid Arthritis according to ACR criteria
- Come from French West Indies (At least 3 grandparents are African-Caribbean)
- Sign written informed consent
- 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)
Who cannot join
- Minor
- Patient with no Rheumatoid Arthritis according to ACR criteria
- Patient does not agree for a genetic study
- For the control
- Minor
- Patient does not agree for a genetic study
Trial locations and contacts
1 site in 1 country.
Martinique1 site
Service de rhumatologie CHU de Fort-de-France
Fort-de-France, 97261
About this study
Official title: 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Collect of 10 ml of peripheric blood for DNA extraction
- Keywords
- Rheumatoid Arthritis, Rheumatoid Arthritis according to ACR criteria of diagnosis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collect of 10 ml of peripheric blood for DNA extractionBiological
Also called Rheumatoid Arthritis, French West-Indian Patients with Rheumatoid Arthritis
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of distribution of HLA alleles in patients and in healthy controls
Measured: 1 day
Secondary outcomes (3)
The association between the different HLA alleles among French West-Indian RA patients and the autoantibodies production.
Measured: 1 day
The association between the different HLA alleles among French West-Indian RA patients and the radiological damage.
Measured: 1 day
The association between the different HLA alleles among French West-Indian RA patients and the response to therapy
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startFeb 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Investigators
- Georges JEAN-BAPTISTE, Professor of medecine, Principal investigator, CHU de Fort-de-France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111357
- Sponsor's protocol ID
- 09/B/02
- Acronym
- HLAPRPA
- Status last verified
- Apr 2010
- First submitted
- 29 Jan 2010
- Last updated
- 21 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of HLA Polymorphisms in French West-Indian Patients With Rheumatoid Arthritis : A Case Control Study
- ClinicalTrials.gov ID
- NCT01111357
- Acronym / sponsor ID
- HLAPRPA / 09/B/02
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Rheumatoid Arthritis according to ACR criteria of diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 27 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Residents of Martinique with at least 3 African-Caribbean grandparents
Key inclusion criteria (7 listed)
- Diagnosis of Rheumatoid Arthritis according to ACR criteria
- Come from French West Indies (At least 3 grandparents are African-Caribbean)
- Sign written informed consent
- Blood donor
- Sign written informed consent
Key exclusion criteria (6 listed)
- Minor
- Patient with no Rheumatoid Arthritis according to ACR criteria
- Patient does not agree for a genetic study
- For the control
- Minor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collect of 10 ml of peripheric blood for DNA extractionAlso: Rheumatoid Arthritis, French West-Indian Patients with Rheumatoid ArthritisAfter 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) | Biological | – |
Primary outcome
Difference of distribution of HLA alleles in patients and in healthy controls
Time frame: 1 day
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georges JEAN-BAPTISTE, Professor of medecine principal investigator
CHU de Fort-de-France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by University Hospital Center of Martinique at 1 site in Martinique.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of distribution of HLA alleles in patients and in healthy controls (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2010.