The Role of IL-23 in Chronic Inflammatory Disease: Exploring the Cellular and Molecular Targets of IL-23 Signaling in Peripheral and Axial Spondyloarthritis
Recruiting now · Not applicable
Conditions studied: Spondyloarthritis
In brief
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).
Key facts
- Study ID
- NCT05290363
- Run by
- Institut Pasteur
- People needed
- 90
- Starts
- 2022-10-06
- Expected to finish
- 2027-09-30
- Last updated by the study team
- 2025-01-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Hôpital Cochin, AP-HP - Department of Dermatology B — Paris, France (enrolling)
- Hôpital Saint-Antoine, AP-HP - Service de Rhumatologie — Paris, France (enrolling)
- Hôpital Henri-Mondor, AP-HP - Service de Rhumatologie — Créteil, France
- Hôpital Maison Blanche - Service de Rhumatologie — Reims, France
Full record on ClinicalTrials.gov
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