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临床试验/NCT01872546
NCT01872546已完成2 期

Characterization of Skin Th17 Transcriptional Profiles in Psoriatic Patients Under Adalimumab Biotherapy

Poitiers University Hospital2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2013年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
18
试验地点
2
主要终点
Analyze modifications of the skin inflammatory

研究概览

简要总结

The expertise in the characterization of transcriptomics profile in lesional psoriatic skin and on the availability of innovative therapy for these patients.The investigators propose to follow the modification of the skin transcriptomics profile in psoriatic patients during successful Adalimumab biotherapy. Skin transcriptomics profiles of normal skin, psoriatic non lesional skin, and psoriatic lesional skin before and after biotherapy will be compared. The investigators will focus on the modification of the cytokine "signature" in these skin lesions and of some markers of keratinocyte inflammation. The modification of the transcriptomics profile induced by the biotherapy will be correlated to the clinical response Psoriasis Area and Severity Index.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults with chronic plaque psoriasis involving at least 10% of body surface area with no previous biotherapy.
  • Adalimumab prescribed in usual practice

排除标准

  • Patients presenting a contraindication to the use of Adalimumab: hypersensibility in Adalimumab or in one of the excipients.
  • Patients presenting an evolutionary tuberculosis or the other severe infections such as sepsis and opportunist infections.
  • Patients with one cardiac insufficiencies moderated in severe.
  • Patients under anakinra or abatacept.
  • Patients with a current participation in another study of clinical research.

研究组 & 干预措施

Adalimumab

Experimental

干预措施: HUMIRA 40mg (Drug)

结局指标

主要结局

Analyze modifications of the skin inflammatory

时间窗: 1 month

comparaison skin biopsy in non-lesional area between skin biopsy lesional area

次要结局

  • skin transcriptomic profile(1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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