The Role of IL-23 in Chronic Inflammatory Disease: Exploring the Cellular and Molecular Targets of IL-23 Signaling in Peripheral and Axial Spondyloarthritis
Blood sampling: A 51 mL blood sample will be collected during the study
synovial aspiration: If synovial aspiration is required in standard care for patients with peripheral spondylarthritis. Medical waste product will be collected for the study
Study summary
This is a research study involving humans, of the interventional type with minimal risks and constraints (RIPH2). It is a multicentric, non randomized prospective study aiming to better understand the mechanisms of the response to anti-IL-23 biologics in Spondyloarthritis patients attending the rheumatology department of Cochin, Saint-Antoine, Henri-Mondor hospitals (APHP) and Maison-Blanche Hospital (Reims).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age : Adults (\>18 years)
* Satisfying ASAS diagnostic criteria for SpA
* Patient has active disease, defined by the presence of active synovitis, tendinitis, or dactylitis or significant inflammatory pain of the spine, judged by the examining clinician to be due to SpA.
* Informed consent signed
* Beneficiary of health insurance, except for the AME
Only for patients of Group 1 • Patient is naïve to biological therapies
Only for patients of Group 2
* Patient is affected by peripheral SpA (ASAS criteria) or psoriatic arthritis, with inflammation of peripheral joints
* Patient requires aspiration, as part of standard care
Non inclusion criteria:
* Patient is minor
* Patient is pregnant or breastfeeding
* Patient is immunocompromised
* Patient has received biological therapy with 2 or more biologics
* Patient is receiving corticosteroid treatment \> 10 mg per day
* Patient is under legal protection, curators, guardianship
* Patient refuses consent
* Previous history of alcoholism, drug addiction, psychological problems, severe concomitant conditions that could invalidate the patient's consent or limit the patient's compliance to the treatment protocol.
* Beneficiary of the AME
Only for group 1
• Patient has received biological therapy
Primary outcome measure(s)
Profiling of open chromatin regions — 4 years Profiling of open chromatin regions (ATAC seq) in T lymphocytes, cultured in the presence or absence of IL-23in order to define the effects of IL-23 on gene expression and cytokine production in innate and adaptive T lymphocytes from patients with SpA, and correlate them with the patient's genotype
Profiling of transcriptome — 4 years Profiling of the transcriptome (RNA-seq) in T lymphocytes, cultured in the presence or absence of IL-23in order to define the effects of IL-23 on gene expression and cytokine production in innate and adaptive T lymphocytes from patients with SpA, and correlate them with the patient's genotype
Profiling of the genome — 4 years Profiling of the genome (genotyping) in T lymphocytes, cultured in the presence or absence of IL-23in order to define the effects of IL-23 on gene expression and cytokine production in innate and adaptive T lymphocytes from patients with SpA, and correlate them with the patient's genotype
Profiling of cytokine expression — 4 years Profiling of cytokine expression (Proximity Extension Assay technology) in T lymphocytes, cultured in the presence or absence of IL-23 in order to define the effects of IL-23 on gene expression and cytokine production in innate and adaptive T lymphocytes from patients with SpA, and correlate them with the patient's genotype
Single cell transcriptome analysis — 4 years Single cell transcriptome analysis of cells from patients with peripheral SpA will be performed to characterize immune cell populations in peripheral blood and in synovial fluid and identify at the single cell level the cells expressing the IL-23 receptor and/or producing IL-17;
Trial sites (4)
Facility
City
Region
Status
Hôpital Henri-Mondor, AP-HP - Service de Rhumatologie
Créteil
France
Not Yet Recruiting
Hôpital Cochin, AP-HP - Department of Dermatology B
Paris
France
Recruiting
Hôpital Saint-Antoine, AP-HP - Service de Rhumatologie
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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