Идёт набор 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

Без фазы С лечением Spondyloarthritis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Blood sampling, synovial aspiration.
Кому может быть актуально: Состояния в реестре: Spondyloarthritis. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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).

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

Profiling of open chromatin regions [Срок оценки: 4 years]
Profiling of transcriptome [Срок оценки: 4 years]
Profiling of the genome [Срок оценки: 4 years]
Profiling of cytokine expression [Срок оценки: 4 years]
Single cell transcriptome analysis [Срок оценки: 4 years]

Вторичные конечные точки (1)

Measure lymphocyte levels to explore the effects of anti-IL23 treatment on the immune responses of axSpA patients [Срок оценки: 4 years]

Критерии участия

Критерии включения

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