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NCT Number: NCT05904301

Armenian NAtionwide REGistry of Systemic Autoimmune and Autoinflammatory Diseases

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

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Erebouni Medical Center, Rheumatology Department, Yerevan, Armenia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Usual medical management of patients, additional blood and stool samples for biobanking

Other

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.

Primary outcomes

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

    Time frame: 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

Secondary outcomes

  1. Identification of rare clinical forms

    Time frame: Through study completion, an average of 5 years

    Clinical and biological correlations to characterize rare clinical forms of each pathology

  2. Prognostic factors of the diseases

    Time frame: Through study completion, an average of 5 years

    Interest in prognostic factors obtained through more targeted radiological examinations and correlation with the response to different treatments.

Study contacts

Contact information is provided by the study sponsor or research team.

Arsene Mekinian, Prof.

CONTACT

[email protected]

01 49 28 23 92 ext. +33

Sponsors and collaborators

Lead sponsor

Santé Arménie French-Armenian Research Center

Other

Registry information

Acronym: NAREG

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jun 15, 2023
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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