Cytokine Expression in Psoriasis Patients With and Without Joint Involvement

Официальное название

Cytokine Expression in Sera, ex Vivo Stimulated Peripheral Blood Mononuclear Cells Culture, and Skin in Psoriasis - Comparison of Patients With and Without Joint Involvement

Обзор

The objective of the resarch is to study the cytokine profile of patients with psoriatic arthritis and psoriasis in order to better understand the pathophysiology of the disease and the contribution of cytokines to the presence or absence of joint involvement. This research will compare cytokines levels in sera, in PBMC culture after LPS or CD3/CD28 agonist antibodies, and in skin biopsy.

Подробное описание

Psoriatic arthritis and Cutaneous Psoriasis are polygenic inflammatory disorders with high burden on the quality of life of patients. Pathophysiology of those disease remain incompletely understood. Recent publications seem to demonstrate an implication of IL-1 family cytokines in the pathogenesis of both diseases. In the literature, results are discordant and focus mainly on cytokines levels in serum of patients. Moreover, few studies compare psoriatic arthritis patients with cutaneous psoriasis patients. We propose here to study cytokines profiles of patients with those conditions in sera, after ex-vivo stimulation of peripheral blood mononuclear cells, and in skin biopsies.

Вмешательства

• Другое Blood sample collection
  Blood sample collection
• Другое Skin sample collection
  Skin sample collection

Первичные конечные точки

• Comparison of cytokine levels in sera, after culture of PBMC stimulated with LPS or CD3/CD28 agonist antibodies between the three groups [Срок оценки: At inclusion]

Вторичные конечные точки (2)

• Comparison of cytokine levels in skin biopsies between Psoriatic Arthritis and Cutaneous Psoriasis patients [Срок оценки: At inclusion]
• Correlation of cytokine levels with rheumatologic disease activity, or dermatologic disease activity [Срок оценки: At inclusion]

Критерии участия

Критерии включения

• For psoriasis patients :

• Age over 18 years old
• Signed informed consent
• 5 year old psoriasis at least
• At least one skin lesion over 2 cm
• Without any articular symptoms
• Without any DMARDs
• Without anticoagulant treatments or coagulation disease
• With normal articular and enthesis sonography
• For psoriatic arthritis patients :

• Age over 18 years old
• Signed informed consent
• Psoriatic arthritis according to CASPAR criteria
• Without any DMARDs
• Without anticoagulant treatments or coagulation disease
• With at least one synovitis at inclusion
• For controls

• Age and sex matched with a patient without any rheumatic or dermatologic medical conditions
• No treatment with corticosteroïds or non-steroïdial anti-inflammatory drugsAge over 18 years old

Критерии исключения

▪ For psoriasis patients :

• Joint damage according to CASPAR criteria
• Echography activity in favor of chronic inflammatory rheumatism
• For patients and controls:
• Without social protection rights
• People under judiciary protection, of less than 18 years old, pregnant woman, breast feeding women, jailed patients.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Франция · 1 центр

• Chu Poitiers — Poitiers

Идентификаторы

NCT: NCT05307809 · CYNEPSA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗