跳至主要内容
临床试验/NCT04132258
NCT04132258已完成不适用

"Clinical and Epidemiological Characteristics of Inflammatory Rhinitis in Patients on Biotherapies"

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 356 人开始时间: 2019年11月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
356
试验地点
1
主要终点
Prevalence of inflammatory rhinitis

研究概览

简要总结

Inflammatory rhinitis is a side effect observed in patients treated with biotherapies in the context of chronic bowel disease (IBD) or spondylartrhopathy (SPA). This damage is still poorly described in the literature. I The objective of this study is to study the associated characteristics of crustal rhinitis in a cohort of patients treated with biotherapy for chronic inflammatory disease (IBD, SPA, psoriasis).

详细描述

Inflammatory rhinitis is a side effect observed in patients treated with biotherapies in the context of chronic bowel disease (IBD) or spondylartrhopathy (SPA). This damage is still poorly described in the literature. It can occur in isolation or in association with a fold pustulose table, which differs from the classic fold pustulose described by Cribier et al in autoimmune diseases by the presence of staphylococcus aureus in the pustules. Some authors also describe associated paradoxical psoriasiform reactions or an impetigo. In our experience, this condition is more frequently found in patients treated for IBD or SPA and has a clinically characteristic fissure appearance. Thus, the semiology but also the epidemiology of this crusty rhinitis is still poorly described.

The objective of this study is to study the associated characteristics of crustal rhinitis in a cohort of patients treated with biotherapy for chronic inflammatory disease (IBD, SPA, psoriasis).

Patient recruitment will take place over a one-year period, in a multi-centre manner (Angers and Nantes University Hospital) with prospective data collection in the form of a questionnaire and clinical evaluation during a dermatology consultation planned in the traditional care pathway for the follow-up of patients with skin manifestations during biotherapy treatment.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Adult patient (> 18 years of age),
  • Biotherapy treatment: anti TNF, ustekinumab, secukinumab, ixekizumab, Rituximab, vedolizumab, abatacept, inhibitor jak kinase, anti Il1, Anti Il6,
  • Biotherapy treatment > 3 months,
  • Chronic inflammatory disease: psoriasis, ankylosing spondylitis (SPA), rheumatoid arthritis (RA), Crohn's disease (CD), bleeding rectocolitis (HRC)
  • No opposition to the study

排除标准

  • Patient under legal protection measure,
  • Refusal of the subject to participate in the study,

结局指标

主要结局

Prevalence of inflammatory rhinitis

时间窗: through study completion, an average of 1 year

Presence of inflammatory rhinitis yes/no

次要结局

  • Characteristics associated with Patient-related characteristics in inflammatory rhinitis.(through study completion, an average of 1 year)
  • Characteristics of rhinitis.(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

"Clinical and Epidemiological Characteristics of... | 临床试验