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临床试验/NCT03374527
NCT03374527已完成不适用

Recirculating Memory T Cells in the Pathogenesis of Psoriatic Arthritis and Cutaneous Psoriasis

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2014年10月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
110
试验地点
1
主要终点
Evaluation of the percentage of different subsets of memory T cells in the circulation of patients with psoriasis, patients with psoriatic arthritis and a control group of healthy subject.

研究概览

简要总结

The aim of the study is to investigate the link between pro-inflammatory T cells responses arising in the skin in patients with cutaneous psoriasis and those present in the joints of patients developing psoriatic arthritis.

The study is based on the hypothesis that a fraction of T cells with memory phenotype can recirculate from the skin and relocalize at extracutaneous sites including enthesis or synovial tissue thus propagating the pro-inflammatory cycle. This could represent a pathogenic mechanism in the development of PsA.

The main aim of the study is to define the phenotypic and functional differences of circulating T cells in patients cutaneous psoriasis, patients with psoriatic arthritis and in control group of healthy subject.

To this end the investigators analyze the expression of cell surface markers of central memory (TCM), effector memory (TEM) and effector (Teff) cells, within this subsets the investigators evaluate the expression of chemokine receptors as well as skin and tissue homing molecules. There will be also an evaluation of the T cell polarization towards Th1/Tc1 or Th17/Tc17 phenotype by evaluating the cytokine expression profile.

In selected patients with PsA the researchers analyze in parallel the phenotype and the cytokine profile of T cell subpopulations in peripheral blood and in synovial fluid, The results of this study could possibly allow to define distinctive features of circulating T cells in patients with PsA and to understand the link between circulating and synovial fluid T cells in patients with PsA.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a diagnosis of cutaneous psoriasis without clinical signs of PsA,
  • Patients with a diagnosis of PsA
  • Healthy subjects with a negative family and personal anamnesis for psoriasis.
  • Absence of acute and chronic systemic or cutaneous infections during sample collections.

排除标准

  • Treatment with cyclosporin A, methotrexate, systemic corticosteroids or any other immunosuppressant agent within 3 weeks before the blood samples collections.

结局指标

主要结局

Evaluation of the percentage of different subsets of memory T cells in the circulation of patients with psoriasis, patients with psoriatic arthritis and a control group of healthy subject.

时间窗: At time of blood collection

Central memory, Effector memory and Effector cell markers are evaluated in circulating CD4 and CD8 T cells. Within these subsets the expression of chemokine receptors is also evaluated and we define the cytokine secretion profile for each subset.

次要结局

  • Correlation between the circulating percentage of individual subsets of CD4 and CD8 T cells and the clinical disease parameters: Psoriasis Area and Severity Index (PASI) Score and serum level of C reactive protein (CRP)(At time of blood collection)
  • Parallel analysis of the phenotype of CD4 and CD8 T cells in the circulation and in synovial fluid of patients with psoriatic arthritis.(At time of blood and synovial fluid collection)

研究者

发起方
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
申办方类型
Other
责任方
Sponsor

研究点 (1)

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