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临床试验/NCT05307809
NCT05307809招募中不适用

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

Poitiers University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年8月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Comparison of cytokine levels in sera, after culture of PBMC stimulated with LPS or CD3/CD28 agonist antibodies between the three groups

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • ▪ 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.

研究组 & 干预措施

Psoriatic arthritis

Experimental

干预措施: Skin sample collection (Other)

Psoriatic arthritis

Experimental

干预措施: Blood sample collection (Other)

Controls

Active Comparator

干预措施: Blood sample collection (Other)

Psoriasis

Experimental

干预措施: Skin sample collection (Other)

Psoriasis

Experimental

干预措施: Blood sample collection (Other)

结局指标

主要结局

Comparison of cytokine levels in sera, after culture of PBMC stimulated with LPS or CD3/CD28 agonist antibodies between the three groups

时间窗: At inclusion

Comparison of cytokine levels in sera, after culture of PBMC stimulated with LPS or CD3/CD28 agonist antibodies between the three groups

次要结局

  • Comparison of cytokine levels in skin biopsies between Psoriatic Arthritis and Cutaneous Psoriasis patients(At inclusion)
  • Correlation of cytokine levels with rheumatologic disease activity, or dermatologic disease activity(At inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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