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Armenian NAtionwide REGistry of Systemic Autoimmune and Autoinflammatory Diseases

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05904301
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Santé Arménie French-Armenian Research Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Merry Mazmanian, Dr.
Principal Investigator Affiliation Santé Arménie Research Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries Armenia
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 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
Additional Details

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.

Arms & Interventions

Arms

: Systemic autoimmune and autoinflammatory diseases

Interventions

Other: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Yerevan, Armenia

Status

Recruiting

Address

Nairi Medical Center, Rheumatology Department

Yerevan, , 0015

Site Contact

Vahan Mukuchayn, Dr.

vmukuchyan@gmail.com

01 49 28 23 92

Yerevan, Armenia

Status

Not yet recruiting

Address

Heratsi Hospital Complex n°1, Rheumatology Department

Yerevan, , 0025

Site Contact

Knarik Ginosyan, Dr.

kginosyan@gmail.com

01 49 28 23 92

Yerevan, Armenia

Status

Not yet recruiting

Address

Erebouni Medical Center, Rheumatology Department

Yerevan, , 0087

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