NAREG: Armenian NAtionwide REGistry of Systemic Autoimmune and Autoinflammatory Diseases

Sponsor

Santé Arménie French-Armenian Research Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05904301

Collaborator

(none)

800

Enrollment

Locations

Anticipated Duration (Months)

400

Patients Per Site

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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	Other: Usual medical management of patients, blood and stool samples for biobanking

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 Design

Study Type:

Observational

Anticipated Enrollment :

800 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Armenian Nationwide Registry of Systemic Autoimmune and Autoinflammatory Diseases

Anticipated Study Start Date :

Jun 30, 2023

Anticipated Primary Completion Date :

Jun 30, 2028

Anticipated Study Completion Date :

Jun 30, 2028

Arms and Interventions

Arm	Intervention/Treatment
Systemic autoimmune and autoinflammatory diseases	Other: Usual medical management of patients, 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.

Arm

Intervention/Treatment

Systemic autoimmune and autoinflammatory diseases

Other: Usual medical management of patients, 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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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