Armenian NAtionwide REGistry of Systemic Autoimmune and Autoinflammatory Diseases

NCT05904301 | Recruiting

• 1 other identifier: SA-2021001
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 6

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Identification of rare clinical forms

  Through study completion, an average of 5 years

• Prognostic factors of the diseases

  Through study completion, an average of 5 years

Study Arms (1)

Systemic autoimmune and autoinflammatory diseases

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

Interventions

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

Systemic autoimmune and autoinflammatory diseases

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Patients refusing to participate in the registry
• Non-consent from legal representative
• Breastfeeding or pregnant patients

Sponsors & Collaborators

• Santé Arménie French-Armenian Research Center: lead

Study Sites (6)

Hematology Center after Prof.R.H. Yeolyan

Yerevan, 0014, Armenia

RECRUITING

Nairi Medical Center, Rheumatology Department

Yerevan, 0015, Armenia

RECRUITING

Heratsi Hospital Complex n°1, Rheumatology Department

Yerevan, 0025, Armenia

NOT YET RECRUITING

Heratsi Hospital Complex №1, Allergology Department

Yerevan, 0025, Armenia

RECRUITING

Mikaelyan Institute of Surgery, Rheumatology Department

Yerevan, 0052, Armenia

RECRUITING

Erebouni Medical Center, Rheumatology Department

Yerevan, 0087, Armenia

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Samples (or components of the samples, PBMCs, DNA, serum, microbiota) taken as part of the study will be stored in a biological sample collection.

MeSH Terms

Conditions

Behcet Syndrome; Takayasu Arteritis; Giant Cell Arteritis; Sjogren's Syndrome; Arthritis, Rheumatoid; Acquired angioedema; Celiac Disease; Arthritis; Angioedema

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular; Aortic Arch Syndromes; Aortic Diseases; Arteritis; Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Connective Tissue Diseases; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Urticaria; Hypersensitivity, Immediate; Hypersensitivity

Study Officials

• Merry Mazmanian, Dr.

  Santé Arménie French - Armenian Academic Research Organization FAARO

  STUDY DIRECTOR

Central Study Contacts

Arsene Mekinian, Prof.

CONTACT

01 49 28 23 92; arsene.mekinian@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 15, 2023
• Study Start: June 21, 2023
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 8, 2025

Record last verified: 2024-11

Locations

AR (6)