Study of Human Leukocyte Antigen (HLA) Polymorphisms in P... | NCT01111357

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

NCT01111357

Sponsor

University Hospital Center of Martinique

Status

Completed

Last Update Posted

Dec 21, 2010Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Rheumatoid Arthritis

Interventions

Collect of 10 ml of peripheric blood for DNA extraction

Countries

Martinique

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Aug 2010Actual

Completion Date

Aug 2010Actual

First Submitted Date

Jan 29, 2010

First Submission Date that Met QC Criteria

Apr 23, 2010

First Posted Date

Apr 27, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 20, 2010

Last Update Posted Date

Dec 21, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Collect of 10 ml of peripheric blood for DNA extraction	Biological	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)		Rheumatoid Arthritis French West-Indian Patients with Rheumatoid Arthritis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference of distribution of HLA alleles in patients and in healthy controls		1 day

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Residents of Martinique with at least 3 African-Caribbean grandparents

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Georges JEAN-BAPTISTE, Professor of medecine	CHU de Fort-de-France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de rhumatologie CHU de Fort-de-France		Fort-de-France		97261	Martinique

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided