Armenian NAtionwide REGistry of Systemic Autoimmune and Autoinflammatory Diseases

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

Detailed Description
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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.

Official Title
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Armenian Nationwide Registry of Systemic Autoimmune and Autoinflammatory Diseases

Conditions
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Behcet Disease, Antineutrophil Cytoplasmic Antibody (ANCA) Positive Vasculitis, Takayasu Arteritis, Giant Cell Arteritis, Sjogren's Syndrome, Rheumatoid Arthritis, Hereditary and Acquired Angioedema, Primary Antiphospholipid Syndrome, Celiac Disease

Intervention / Treatment
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* Other: Usual medical management of patients, additional blood and stool samples for biobanking


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Systemic autoimmune and autoinflammatory diseases<br> | Other: Usual medical management of patients, additional blood and stool samples for biobanking<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic manifestations and evolution of the diseases under treatment by disease-specific activity scores | 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 | Through study completion, an average of 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of rare clinical forms | Clinical and biological correlations to characterize rare clinical forms of each pathology | Through study completion, an average of 5 years | 
| Prognostic factors of the diseases | Interest in prognostic factors obtained through more targeted radiological examinations and correlation with the response to different treatments. | Through study completion, an average of 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behcet, arthritis, autoimmune, systemic, autoinflammatory, Takayasu, Giant Cell, Angioedema, APS