ClinicalTrials.gg
RecruitingNCT05904301NAREGUpdated Apr 8, 2025

Armenian NAtionwide REGistry of Systemic Autoimmune and Autoinflammatory Diseases

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

From the registry’s dates

  • Started Jun 2023; still recruiting 3 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
800
Sex
All
01

Study summary

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

Read the 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.

02

Conditions 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

Keywords

  • arthritis
  • autoimmune
  • systemic
  • autoinflammatory
  • Behcet
  • Takayasu
  • Giant Cell
  • Angioedema
  • APS
03

In context

Behcet Syndrome

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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

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.

Inclusion criteria

  1. 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.

  2. Age: major and minor
  3. Patients who have been informed and provided with written to participate Or consent from legal representative

Exclusion criteria

Exclusion Criteria:

  1. Patients refusing to participate in the registry
  2. Non-consent from legal representative
  3. Breastfeeding or pregnant patients
Terms in these criteria, in plain language(2)

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.

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.

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Systemic autoimmune and autoinflammatory diseases

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

Interventions

  • OtherUsual 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.

06

What researchers measure

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

    Time frame: Through study completion, an average of 5 years

Secondary outcomes

  1. 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

  2. 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

07

Study locations

4 of 6 sites recruiting
  • Hematology Center after Prof.R.H. Yeolyan
    Yerevan, 0014, Armenia
    Recruiting
  • Nairi Medical Center, Rheumatology Department
    Yerevan, 0015, Armenia
    Recruiting
    • Vahan Mukuchayn, Dr. · Contactvmukuchyan@gmail.com
    • Vahan Mukuchyan, Dr. · Principal investigator
  • 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
    • Armine Haroyan, Dr. · Principal investigator
    • Magda Osipyan, Dr. · Sub investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

Registered
May 25, 2023
First posted
Jun 15, 2023
StartActual
Jun 21, 2023
Primary completionEst.
Jun 30, 2028
CompletionEst.
Jun 30, 2028
Last update
Apr 8, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05904301
Lead sponsor
Santé Arménie French-Armenian Research Center
Responsible party
Sponsor
First posted
Jun 15, 2023
Start date
Jun 21, 2023
Primary completion
Jun 30, 2028 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Apr 8, 2025

Study contacts

Arsene Mekinian, Prof.
Contact
arsene.mekinian@aphp.fr
01 49 28 23 92 ext. +33
Merry Mazmanian, Dr.
study director · Santé Arménie French - Armenian Academic Research Organization FAARO

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion