Clinical trial NCT05904301: Armenian NAtionwide REGistry of Systemic Autoimmune and Autoinflammatory Diseases
Official title: Armenian Nationwide Registry of Systemic Autoimmune and Autoinflammatory Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Keywords: arthritis
autoimmune
systemic
autoinflammatory
Behcet
Takayasu
Giant Cell
Angioedema
APS
Lead sponsor: Santé Arménie French-Armenian Research Center
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients and inpatients at participating centers, major and minor patients with a confirmed diagnosis of at least one of autoimmune systemic diseases

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.

Eligibility criteria: 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

Primary outcomes:
measure: Systemic manifestations and evolution of the diseases under treatment by disease-specific activity scores
timeFrame: Through study completion, an average of 5 years
Secondary outcomes:
measure: Identification of rare clinical forms
timeFrame: Through study completion, an average of 5 years
measure: Prognostic factors of the diseases
timeFrame: Through study completion, an average of 5 years
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: Hematology Center after Prof.R.H. Yeolyan
city: Yerevan
country: Armenia
facility: Nairi Medical Center, Rheumatology Department
city: Yerevan
country: Armenia
facility: Heratsi Hospital Complex n°1, Rheumatology Department
city: Yerevan
country: Armenia
facility: Heratsi Hospital Complex №1, Allergology Department
city: Yerevan
country: Armenia
facility: Mikaelyan Institute of Surgery, Rheumatology Department
city: Yerevan
country: Armenia
facility: Erebouni Medical Center, Rheumatology Department
Study officials:
affiliation: Santé Arménie French - Armenian Academic Research Organization FAARO
name: Merry Mazmanian, Dr.
role: STUDY_DIRECTOR
References: