The Role of IL-23 in Chronic Inflammatory Disease: Exploring the Cellular and Molecular Targets of IL-23 Signaling in Peripheral and Axial Spondyloarthritis
NCT ID: NCT05290363
Last Updated: 2025-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2022-10-06
2027-09-30
Brief Summary
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Detailed Description
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This objective is detailed in three specific aims:
1. 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;
2. Phenotypically characterize immune cell populations in peripheral blood and in synovial fluid from peripheral SpA patients and identify at the single cell level the cells expressing the IL-23 receptor and/or producing IL-17.
The study population to be included are patients affected by SpA, attended to in the Rheumatology Departments of Cochin Hospital, Saint-Antoine Hospital Henri-Mondor hospitals in Paris (APHP) and Maison-Blanche Hospital in Reims. Participants will be divided into two groups: Group 1 comprises patients diagnosed with axial SpA, Group 2 SpA patients with peripheral SpA or psoriatic arthritis.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Patients with axial spondyloarthritis participating in the study
People with axial spondylarthritis (60 participants),
Blood sampling
A 51 mL blood sample will be collected during the study
Patients with peripheral spondyloarthritis participating in the study
People with peripheral spondylarthritis or psoriatic arthritis (30 participants).
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Janssen Biotech, Inc.
INDUSTRY
Institut Pasteur
INDUSTRY
Responsible Party
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Locations
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Hôpital Henri-Mondor, AP-HP - Service de Rhumatologie
Créteil, , France
Hôpital Cochin, AP-HP - Department of Dermatology B
Paris, , France
Hôpital Saint-Antoine, AP-HP - Service de Rhumatologie
Paris, , France
Hôpital Maison Blanche - Service de Rhumatologie
Reims, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-A02801-40
Identifier Type: OTHER
Identifier Source: secondary_id
2021-087
Identifier Type: -
Identifier Source: org_study_id
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