Actively Recruiting
The Role of IL-23 in Chronic Inflammatory Disease: Exploring Cellular and Molecular Targets in Peripheral and Axial Spondyloarthritis
Led by Institut Pasteur · Updated on 2025-01-23
90
Participants Needed
4
Research Sites
260 weeks
Total Duration
On this page
Sponsors
I
Institut Pasteur
Lead Sponsor
J
Janssen Biotech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the role of IL-23 in the disease processes of axial and peripheral Spondyloarthritis (SpA). This multicenter, non-randomized prospective study aims to better understand how patients with SpA respond to anti-IL-23 biologic treatments. The study involves patients attending rheumatology departments at several hospitals in France, divided into two groups: those with axial SpA and those with peripheral SpA or psoriatic arthritis. Participants will undergo blood sampling, with a total of 51 mL collected during the study. For patients with peripheral SpA who require it as part of their standard care, synovial fluid will also be collected through aspiration and used for research purposes. The study focuses on analyzing immune cell populations, gene expression, and cytokine production related to IL-23 signaling in these patients. During the four-year study period, researchers will profile open chromatin regions, transcriptomes, genomes, cytokine expression, and perform single-cell transcriptome analysis. These assessments will help characterize immune cells from blood and synovial fluid, identify IL-23 receptor-expressing cells, and correlate findings with patient genotypes. Participants will be closely monitored throughout, with data collected to understand disease mechanisms and responses to biologic therapy.
CONDITIONS
Official Title
The Role of IL-23 in Chronic Inflammatory Disease: Exploring the Cellular and Molecular Targets of IL-23 Signaling in Peripheral and Axial Spondyloarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults older than 18 years
- Diagnosed with Spondyloarthritis according to ASAS criteria
- Have active disease with signs such as active synovitis, tendinitis, dactylitis, or significant inflammatory spinal pain
- Able to provide informed consent
- Covered by health insurance (except AME beneficiaries)
For patients with axial SpA (Group 1):
- Biologic therapy naive
For patients with peripheral SpA or psoriatic arthritis (Group 2):
- Diagnosed with peripheral SpA or psoriatic arthritis with peripheral joint inflammation
- Require synovial fluid aspiration as part of standard care
You will not qualify if you...
- Under 18 years of age
- Pregnant or breastfeeding
- Immunocompromised
- Have received two or more biologic therapies
- Receiving corticosteroid treatment over 10 mg per day
- Under legal protection such as guardianship or curatorship
- Refuse to give consent
- Have a history of alcoholism, drug addiction, psychological problems, or severe conditions that may affect consent or protocol compliance
- Beneficiary of AME
For patients with axial SpA (Group 1):
- Have received any biological therapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Hôpital Henri-Mondor, AP-HP - Service de Rhumatologie
Créteil, France, 94000
Not Yet Recruiting
2
Hôpital Cochin, AP-HP - Department of Dermatology B
Paris, France
Actively Recruiting
3
Hôpital Saint-Antoine, AP-HP - Service de Rhumatologie
Paris, France
Actively Recruiting
4
Hôpital Maison Blanche - Service de Rhumatologie
Reims, France, 51092
Not Yet Recruiting
Research Team
L
Lars ROGGE, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Frequently Asked Questions
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