- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07718815
HLA B Leader in Patients With Psoriatic Arthritis (HLABLRP)
Psoriatic arthritis (PsA), a chronic immune-mediated heterogeneous inflammatory disease characterized by musculoskeletal inflammation (arthritis, enthesitis, spondylitis and dactylitis), usually occurs in patients with psoriasis. The spondyloarthritides (SPs) (of which psoriasis is one) are a group of inflammatory diseases that share an association with the HLA-B27 MHC class I molecule.
Given this association, these diseases are classically regarded as disorders of adaptive immunity.
In bone marrow donation, HLA-B exon 1 dimorphism (HLAB leader) is associated with risk of graft- versus-host disease, relapse and overall survival after unrelated hematopoietic cell transplantation (UHCT), haploidentical UHCT and cord transplantation. In the literature, there are no studies suggesting the involvement of the HLA B leader gene in MS and RPs. The main aim of this study is to compare the presence of the HLA B leader gene between a group of patients with psoriatic arthritis and a healthy group without inflammatory disease.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Vincent Goeb, Pr
- Phone Number: 33+3.22.08.83.71
- Email: Goeb.vincent@chu-amiens.fr
Study Locations
-
-
Picardie
-
Amiens, Picardie, France, 80054
- Recruiting
- CHU Amiens Picardie
-
Contact:
- Vincent GOEB, Pr
- Phone Number: +33322668259
- Email: goeb.vincent@chu-amiens.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- For the "Patient" group:
- Patient over 18 years of age
- Patient affiliated to a social security scheme
- Patient with psoriatic arthritis according to the CASPAR 2006 classification, followed at the CHU Amiens-Picardie.
- For the "control" group:
- Individuals over 18 years of age
- Individual affiliated to a social security scheme
- Individual having agreed to participate in the study
- Individuals with no inflammatory or autoimmune diseases
Exclusion Criteria:
- Patient or control not understanding French
- Patient not included in the Amiens Picardie University Hospital's "Psoriatic Rheumatism" cohort, or control not included in the Amiens Picardie University Hospital's bone marrow donor cohort.
- Patient or control objecting to participation in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: psoriatic rheumatism patient
patients with psoriatic arthritis
|
Addition of an extra tube for blood tests (a single tube for genetic research), enabling phenotyping of the HLA B27 and HLA B leader genes.
|
|
Active Comparator: healthy group
patients without inflammatory disease
|
Addition of an extra tube for blood tests (a single tube for genetic research), enabling phenotyping of the HLA B27 and HLA B leader genes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
prevalence of HLA B leader in both groups
Time Frame: 1 year
|
prevalence of HLA B leader in patients with psoriatic rheumatism compared to the healthy group by autoimmune disease
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of HLAB27 gene in both groups
Time Frame: 1 year
|
Prevalence of HLAB27 gene in patients with psoriatic rheumatism compared to the healthy group free from autoimmune disease
|
1 year
|
|
prevalence of the HLAB27/ HLA b Leader gene in different forms of psoriatic rheumatism patient group
Time Frame: 1 year
|
prevalence of the HLAB27/ HLA b Leader gene in different forms of psoriatic rheumatism in patients with different disease conditions
|
1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Bone Diseases
- Musculoskeletal Diseases
- Arthritis
- Joint Diseases
- Spinal Diseases
- Spondylarthropathies
- Skin Diseases, Papulosquamous
- Skin Diseases
- Spondylarthritis
- Spondylitis
- Psoriasis
- Skin and Connective Tissue Diseases
- Arthritis, Psoriatic
- Investigative Techniques
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Hematologic Tests
Other Study ID Numbers
- PI2024_843_0115
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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