跳至主要内容
临床试验/NCT05904301
NCT05904301招募中不适用

Armenian Nationwide Registry of Systemic Autoimmune and Autoinflammatory Diseases

Santé Arménie French-Armenian Research Center6 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2023年6月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
800
试验地点
6
主要终点
Systemic manifestations and evolution of the diseases under treatment by disease-specific activity scores

研究概览

简要总结

Longitudinal prospective multicenter Armenian registry of systemic autoimmune, autoinflammatory diseases with constitution of bio-banking.

详细描述

Autoimmune and auto inflammatory diseases are a growing group of disorders caused by a dysregulation of the innate immune system leading to episodes of systemic inflammation.

They represent a group of diseases characterized by excessive autoimmune or inflammatory reaction leading to various organ damage and drop in patient's quality of life, usually underlined by particular genetic factors and environmental triggers.

The progress of these diseases is often evaluated in the form of activity scores.

A number of scores are available to predict the evolution of autoimmune autoinflammatory diseases.

For a long time, these pathologies have remained slightly explored because of their complex physiopathology and the absence of specific therapies.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with a confirmed diagnosis of at least one of following autoimmune systemic diseases:
  • Behcet disease, ANCA -positive vasculitis, Takayasu arteritis, Giant cell arteritis, Systemic sclerosis, Sjogren syndrome, Rheumatoid arthritis, Spondylarthritis (psoriatic, ankylosing, crohn's related), Angioedema hereditary and acquired, Pediatric dermatology, Autoinflammatory diseases (hereditary and acquired), Unexplained infertility, Immune thrombocytopenic purpura/ Autoimmune hemolytic anemia (ITP, AHA), Primary anti-phospholipid syndrome (APS), Celiac disease.
  • Age: major and minor
  • Patients who have been informed and provided with written informed consent to participate Or consent from legal representative

排除标准

  • Patients refusing to participate in the registry
  • Non-consent from legal representative
  • Breastfeeding or pregnant patients

结局指标

主要结局

Systemic manifestations and evolution of the diseases under treatment by disease-specific activity scores

时间窗: Through study completion, an average of 5 years

Description of Initial manifestations and the progress of these diseases. The progress of these diseases is assessed in the form of disease-specific activity scores: * ANCA-positive vasculitis - BVAS * Takayasu arthritis - NIH criteria * Rheumatoid arthritis - DAS28 * Sjogren syndrome - ESSDAI, ESSRPI

次要结局

  • Identification of rare clinical forms(Through study completion, an average of 5 years)
  • Prognostic factors of the diseases(Through study completion, an average of 5 years)

研究者

发起方
Santé Arménie French-Armenian Research Center
申办方类型
Other
责任方
Sponsor

研究点 (6)

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