An observational study in Behcet Disease, Antineutrophil Cytoplasmic Antibody (ANCA) Positive Vasculitis and Takayasu Arteritis, sponsored by Santé Arménie French-Armenian Research Center. Recruiting at 6 sites in Armenia. Per ClinicalTrials.gov, last updated 2025-04-08.
Sponsored by Santé Arménie French-Armenian Research Center · Observational
Longitudinal prospective multicenter Armenian registry of systemic autoimmune, autoinflammatory diseases with constitution of bio-banking.
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.
136 studies on the registry are indexed under Behcet Syndrome; 42 are open to participants now.
This study's planned enrollment of 800 is above the median of 90 across 63 observational studies indexed under Behcet Syndrome.
Browse Behcet Syndrome studies →This is the only study on the registry with Santé Arménie French-Armenian Research Center as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Outpatients and inpatients at participating centers, major and minor patients with a confirmed diagnosis of at least one of autoimmune systemic diseases
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients with a confirmed diagnosis of at least one of following 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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
Time frame: Through study completion, an average of 5 years
Identification of rare clinical forms
Clinical and biological correlations to characterize rare clinical forms of each pathology
Time frame: Through study completion, an average of 5 years
Prognostic factors of the diseases
Interest in prognostic factors obtained through more targeted radiological examinations and correlation with the response to different treatments.
Time frame: Through study completion, an average of 5 years
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jun 2023 (actual). Primary completion is estimated for Jun 2028, 60 months after the start.
Of 21 observational studies under Behcet Syndrome, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 81. This study's planned 60 months is above that.
How these figures are worked out, and which studies are left out of them.
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