Armenian NAtionwide REGistry of Systemic Autoimmune and Autoinflammatory Diseases

NCT ID: NCT05904301

Last Updated: 2025-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-21

Study Completion Date

2028-06-30

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.

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Systemic autoimmune and autoinflammatory diseases

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

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Santé Arménie French-Armenian Research Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Merry Mazmanian, Dr.

Role: STUDY_DIRECTOR

Santé Arménie French - Armenian Academic Research Organization FAARO

Locations

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Hematology Center after Prof.R.H. Yeolyan

Yerevan, , Armenia

Site Status RECRUITING

Nairi Medical Center, Rheumatology Department

Yerevan, , Armenia

Site Status RECRUITING

Heratsi Hospital Complex n°1, Rheumatology Department

Yerevan, , Armenia

Site Status NOT_YET_RECRUITING

Heratsi Hospital Complex №1, Allergology Department

Yerevan, , Armenia

Site Status RECRUITING

Mikaelyan Institute of Surgery, Rheumatology Department

Yerevan, , Armenia

Site Status RECRUITING

Erebouni Medical Center, Rheumatology Department

Yerevan, , Armenia

Site Status NOT_YET_RECRUITING

Countries

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Armenia

Central Contacts

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Arsene Mekinian, Prof.

Role: CONTACT

01 49 28 23 92 ext. +33

Facility Contacts

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Liana Hambardzumyan, Dr.

Role: primary

Vahan Mukuchayn, Dr.

Role: primary

Knarik Ginosyan, Dr.

Role: primary

Merry Mazmanian, Dr.

Role: backup

Armine Hakobyan, Dr.

Role: primary

Valentina Vardanyan, Dr.

Role: primary

+37499066115

Other Identifiers

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SA-2021001

Identifier Type: -

Identifier Source: org_study_id

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