Armenian NAtionwide REGistry of Systemic Autoimmune and Autoinflammatory Diseases

Официальное название

Armenian Nationwide Registry of Systemic Autoimmune and Autoinflammatory Diseases

Обзор

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

Подробное описание

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.

In the last few years, significant progress has been made in terms of both pathophysiology and treatment.

Treatment with biological targeted therapies transformed the prognosis and survival of the patients, improved their quality of life and underlined the necessity of a global management of these patients.

In Armenia, the epidemiological elements of these pathologies are not known, nor are the circumstances of their discovery. The initial biological manifestations and the management of these patients are variable from one center to another, whether in terms of supportive or specific therapeutic elements.

Вмешательства

• Другое Usual medical management of patients, additional blood and stool samples for biobanking
  For all systemic diseases the following data will be collected: Clinical examination, Laboratory data, Current medications, Constitution of biobanking. For each disease: Pathology specific Activity score, Global subjective disease activity by patient and by physician.

Первичные конечные точки

• Systemic manifestations and evolution of the diseases under treatment by disease-specific activity scores [Срок оценки: Through study completion, an average of 5 years]

Вторичные конечные точки (2)

• Identification of rare clinical forms [Срок оценки: Through study completion, an average of 5 years]
• Prognostic factors of the diseases [Срок оценки: Through study completion, an average of 5 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Армения · 6 центров

• Hematology Center after Prof.R.H. Yeolyan — Yerevan
• Nairi Medical Center, Rheumatology Department — Yerevan
• Heratsi Hospital Complex n°1, Rheumatology Department — Yerevan
• Heratsi Hospital Complex №1, Allergology Department — Yerevan
• Mikaelyan Institute of Surgery, Rheumatology Department — Yerevan
• Erebouni Medical Center, Rheumatology Department — Yerevan

Идентификаторы

NCT: NCT05904301 · SA-2021001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗