Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05290363

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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