跳至主要内容
临床试验/NCT04227535
NCT04227535进行中(未招募)不适用

Deciphering Rheumatoid Arthritis-associated Interstitial Lung Disease Pathogenesis 2

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 509 人开始时间: 2020年2月3日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
509
试验地点
1
主要终点
Identification of genetic factors implicated in RA-ILD using whole exome sequencing (WES).

研究概览

简要总结

The overall goal of this study is to identify risk and prognosis factors of Interstitial Lung Disease (ILD) in patients with rheumatoid arthritis (RA).

详细描述

This is not an interventional study. This is a study designed to recruit individuals affected by RA and investigate associated ILD to better understand the clinical phenotypes and genetic/molecular endotypes of RAILD, including the prognosis of the disease.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Age ≥18 years
  • RA diagnosis according to ACR (classification of rheumatoid arthritis) 1987 and/or ACR/EULAR 2010 criteria, validated by a senior rheumatologist
  • ILD diagnosis based on typical High-Resolution Computed-Tomography (HCRT) patterns and pulmonary function tests (PFT), validated by a senior pulmonologist

排除标准

  • Lack of signed informed consent
  • SELECTION OF CONTROLS:
  • Inclusion Criteria:
  • Age ≥18 years
  • RA diagnosis according to ACR 1987 and/or ACR/EULAR 2010 criteria, validated by a senior rheumatologist
  • Exclusion Criteria:
  • Lack of signed informed consent

结局指标

主要结局

Identification of genetic factors implicated in RA-ILD using whole exome sequencing (WES).

时间窗: Baseline

whole exome sequencing data

次要结局

  • Describe RA-ILD natural history by a 5 years annual follow up of RA-ILD patients.(Every year during 5 years)
  • Description of the effect of disease modifying Anti Rheumatic Drugs (DMARDs) on ILD course and mortality.(Every year during 5 years)
  • Identification of genetic factors implicated in RA-ILD using genome wide association study.(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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