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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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 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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Hôpital Henri-Mondor, AP-HP - Service de Rhumatologie
NOT_YET_RECRUITING
Créteil
Hôpital Cochin, AP-HP - Department of Dermatology B
RECRUITING
Paris
Hôpital Saint-Antoine, AP-HP - Service de Rhumatologie
RECRUITING
Paris
Hôpital Maison Blanche - Service de Rhumatologie
NOT_YET_RECRUITING
Reims
Contact Information
Primary
Lars ROGGE, Dr
lars.rogge@pasteur.fr
+33140613822
Time Frame
Start Date: 2022-10-06
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 90
Treatments
Experimental: Patients with axial spondyloarthritis participating in the study
People with axial spondylarthritis (60 participants),
Experimental: Patients with peripheral spondyloarthritis participating in the study
People with peripheral spondylarthritis or psoriatic arthritis (30 participants).
Sponsors
Collaborators: Janssen Biotech, Inc.
Leads: Institut Pasteur

This content was sourced from clinicaltrials.gov