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Recruiting NCT05290363

The Role of IL-23 in Chronic Inflammatory Disease: Exploring the Cellular and Molecular Targets of IL-23 Signaling in Peripheral and Axial Spondyloarthritis

No phase Interventional Spondyloarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood sampling, synovial aspiration.
Who it may be relevant to
Registry conditions: Spondyloarthritis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Detailed description

The aim of this project is to improve our understanding of the role of IL-23 in the pathophysiology of axial SpA and peripheral SpA.

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.

Interventions

  • Other Blood sampling
    A 51 mL blood sample will be collected during the study
  • Other synovial aspiration
    If synovial aspiration is required in standard care for patients with peripheral spondylarthritis. Medical waste product will be collected for the study

Primary outcome measures

  • Profiling of open chromatin regions [Time frame: 4 years]
  • Profiling of transcriptome [Time frame: 4 years]
  • Profiling of the genome [Time frame: 4 years]
  • Profiling of cytokine expression [Time frame: 4 years]
  • Single cell transcriptome analysis [Time frame: 4 years]
Secondary outcome measures (1)
  • Measure lymphocyte levels to explore the effects of anti-IL23 treatment on the immune responses of axSpA patients [Time frame: 4 years]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 4 centers
  • Hôpital Henri-Mondor, AP-HP - Service de Rhumatologie — Créteil
  • Hôpital Cochin, AP-HP - Department of Dermatology B — Paris
  • Hôpital Saint-Antoine, AP-HP - Service de Rhumatologie — Paris
  • Hôpital Maison Blanche - Service de Rhumatologie — Reims

Identifiers

NCT: NCT05290363 · 2021-087 · 2021-A02801-40

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗