ClinicalTrials.gov record NCT05904301

Armenian NAtionwide REGistry of Systemic Autoimmune and Autoinflammatory Diseases

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 16, 2026

Armenian Nationwide Registry of Systemic Autoimmune and Autoinflammatory Diseases

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
SexAll
LocationArmenia
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

A prospective, observational registry collecting clinical information and biological samples from people with systemic autoimmune and autoinflammatory diseases. The study records disease-specific activity scores and usual medical care while creating a biobank of blood and stool. Data will be used to track disease manifestations and evolution over time.

What it is studying. Whether and how clinical features, disease activity scores, and biological samples can characterize disease presentations, identify rare forms, and support research into prognostic factors.

What the researchers hope to learn. Describe initial manifestations and the course of these diseases using disease-specific activity scores; identify rare clinical forms through clinical and biological correlations; study prognostic factors and correlations with imaging and treatment responses; build a biobank of blood and stool samples for future research.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

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

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants continue their usual medical care while the registry collects information about their condition and treatment. At clinic visits staff will record a clinical exam, laboratory data, current medications, and disease-specific activity scores; patients will also report their own global disease activity. Additional blood and stool samples will be collected and stored in a biobank for future research. The record describes follow-up through study completion (an average of about 5 years).

How the study is structured. This is a prospective observational cohort registry. Participants receive their usual medical care; the study adds collection of clinical exam findings, disease-specific activity scores, and additional blood and stool samples for biobanking. Data are collected over time (outcomes described through study completion, about five years on average). There is a single group (no randomization or masking described).

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in Armenia. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Behçet's disease

This trial is also listed on this site under familial Mediterranean fever.

Clinical trials34 trials listed for Behçet's diseaseEvery trial the registry lists for Behçet's disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Behçet's disease researchLatest monthly update: September 2026. Includes: Low-dose IL-2 trial. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jun 21, 2023
Primary completion
Jun 30, 2028 (estimated)
Study completion
Jun 30, 2028 (estimated)
Target enrollment
800 participants (estimated)
Last updated on registry
Apr 8, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Santé Arménie French-Armenian Research Center

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (6)

  • Hematology Center after Prof.R.H. YeolyanRecruiting

    Yerevan, 0014 · Armenia

  • Nairi Medical Center, Rheumatology DepartmentRecruiting

    Yerevan, 0015 · Armenia

  • Heratsi Hospital Complex n°1, Rheumatology DepartmentNot Yet Recruiting

    Yerevan, 0025 · Armenia

  • Heratsi Hospital Complex №1, Allergology DepartmentRecruiting

    Yerevan, 0025 · Armenia

  • Mikaelyan Institute of Surgery, Rheumatology DepartmentRecruiting

    Yerevan, 0052 · Armenia

  • Erebouni Medical Center, Rheumatology DepartmentNot Yet Recruiting

    Yerevan, 0087 · Armenia

    • Armine Haroyan, Dr.
    • Magda Osipyan, Dr.

Terms used on this page · explanations by MedicalUpdates.ai

registry
An organised collection of information about people with a particular condition, gathered over time for research. Joining a registry usually means sharing medical information, not receiving a treatment.
written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
legal representative
A person who is legally allowed to make decisions, including consent to research, on behalf of someone who cannot consent for themselves.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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