Armenian NAtionwide REGistry of Systemic Autoimmune and Autoinflammatory Diseases

Recruiting

• Conditions: Antineutrophil Cytoplasmic Antibody (ANCA) Positive Vasculitis; Takayasu Arteritis; Giant Cell Arteritis; Rheumatoid Arthritis; Hereditary and Acquired Angioedema; Primary Antiphospholipid Syndrome; Behcet Disease; Sjogren's Syndrome; Celiac Disease
• Interventions: Other: Usual medical management of patients, additional blood and stool samples for biobanking

• Registration Number: NCT05904301
• Lead Sponsor: Santé Arménie French-Armenian Research Center

Brief Summary

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.

Study Timeline

• Study First Submitted: 2023-05-25
• Study First Submitted QC: 2023-06-13
• Study First Posted: 2023-06-15
• Study Start: 2023-06-21
• Status Verified: 2024-11
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-08
• Primary Completion: 2028-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

1. 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.

2. Age: major and minor

3. Patients who have been informed and provided with written informed consent to participate Or consent from legal representative

Exclusion Criteria

1. Patients refusing to participate in the registry
2. Non-consent from legal representative
3. Breastfeeding or pregnant patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Systemic autoimmune and autoinflammatory diseases	Usual medical management of patients, additional blood and stool samples for biobanking	-

Primary Outcome Measures

Name	Time	Method
Systemic manifestations and evolution of the diseases under treatment by disease-specific activity scores	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 Outcome Measures

Name	Time	Method
Identification of rare clinical forms	Through study completion, an average of 5 years	Clinical and biological correlations to characterize rare clinical forms of each pathology
Prognostic factors of the diseases	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.

Trial Locations

Locations (6)

Hematology Center after Prof.R.H. Yeolyan; 🇦🇲 Yerevan, Armenia

Heratsi Hospital Complex №1, Allergology Department; 🇦🇲 Yerevan, Armenia

Mikaelyan Institute of Surgery, Rheumatology Department; 🇦🇲 Yerevan, Armenia

Nairi Medical Center, Rheumatology Department; 🇦🇲 Yerevan, Armenia

Heratsi Hospital Complex n°1, Rheumatology Department; 🇦🇲 Yerevan, Armenia

Erebouni Medical Center, Rheumatology Department; 🇦🇲 Yerevan, Armenia