Exploring the role of IL-23 in spondyloarthritis
The Role of IL-23 in Chronic Inflammatory Disease: Exploring the Cellular and Molecular Targets of IL-23 Signaling in Peripheral and Axial Spondyloarthritis
This study is trying to see how a protein called IL-23 affects immune cells in people with spondyloarthritis to better understand the disease and its different types.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Pasteur Industry-sponsored |
| Locations | 4 sites (Créteil and 3 other locations) |
| Trial ID | NCT05290363 on ClinicalTrials.gov |
What this trial studies
This study investigates the role of interleukin-23 (IL-23) in chronic inflammatory diseases, specifically focusing on spondyloarthritis (SpA). It aims to understand how IL-23 affects gene expression and cytokine production in T lymphocytes from SpA patients, correlating these effects with patient genotypes. Additionally, the study will characterize immune cell populations in blood and synovial fluid from patients with peripheral SpA and identify cells expressing the IL-23 receptor. Participants will be recruited from multiple hospitals in Paris and Reims, and will be divided into groups based on their specific type of SpA.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with active spondyloarthritis who meet the ASAS diagnostic criteria.
Not a fit: Patients who are minors, pregnant, breastfeeding, or have received multiple biological therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatments for patients with spondyloarthritis by targeting IL-23 signaling.
How similar studies have performed: Other studies targeting IL-23 have shown promise in treating inflammatory conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Créteil and 3 other locations
- 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 — Paris, France (Recruiting)
- Hôpital Maison Blanche - Service de Rhumatologie — Reims, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Lars ROGGE, Dr
- Email: lars.rogge@pasteur.fr
- Phone: +33140613822
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.