Armenian NAtionwide REGistry of Systemic Autoimmune and Autoinflammatory Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Usual medical management of patients, additional blood and stool samples for biobanking.
- Who it may be relevant to
- Registry conditions: Behcet Disease, Antineutrophil Cytoplasmic Antibody (ANCA) Positive Vasculitis, Takayasu Arteritis, Giant Cell Arteritis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Armenia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Armenian Nationwide Registry of Systemic Autoimmune and Autoinflammatory Diseases
Overview
Longitudinal prospective multicenter Armenian registry of systemic autoimmune, autoinflammatory diseases with constitution of bio-banking.
Detailed description
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.
Interventions
- Other 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.
Primary outcome measures
- Systemic manifestations and evolution of the diseases under treatment by disease-specific activity scores [Time frame: Through study completion, an average of 5 years]
Secondary outcome measures (2)
- Identification of rare clinical forms [Time frame: Through study completion, an average of 5 years]
- Prognostic factors of the diseases [Time frame: Through study completion, an average of 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Armenia · 6 centers
- 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
Identifiers
NCT: NCT05904301 · SA-2021001