NCT05290363Recruiting
The Role of IL-23 in Chronic Inflammatory Disease: Exploring the Cellular and Molecular Targets of IL-23 Signaling in Peripheral and Axial Spondyloarthritis
Source: ClinicalTrials.gov · Last updated 23 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 25 Feb 2022
- Start date
- 6 Oct 2022
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Institut Pasteur
- Diseases
- Ankylosing spondylitis
- NCT number
- NCT05290363
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 6 Oct 2022 to the primary completion date, 30 Sept 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Henri-Mondor, AP-HP - Service de Rhumatologie Coordinator of this site? Confirm its status | Créteil | France | Not yet recruiting |
| Hôpital Cochin, AP-HP - Department of Dermatology B Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hôpital Saint-Antoine, AP-HP - Service de Rhumatologie Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hôpital Maison Blanche - Service de Rhumatologie Coordinator of this site? Confirm its status | Reims | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.