Status:
RECRUITING
The Role of IL-23 in Chronic Inflammatory Disease: Exploring the Cellular and Molecular Targets of IL-23 Signaling in Peripheral and Axial Spondyloarthritis
Lead Sponsor:
Institut Pasteur
Collaborating Sponsors:
Janssen Biotech, Inc.
Conditions:
Spondyloarthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05290363
Start Date
October 6 2022
End Date
September 30 2027
Last Update
January 23 2025
Active Locations (4)
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1
Hôpital Henri-Mondor, AP-HP - Service de Rhumatologie
Créteil, France, 94000
2
Hôpital Cochin, AP-HP - Department of Dermatology B
Paris, France
3
Hôpital Saint-Antoine, AP-HP - Service de Rhumatologie
Paris, France
4
Hôpital Maison Blanche - Service de Rhumatologie
Reims, France, 51092