Behcet DiseaseNAREGNCT05904301
Armenian NAtionwide REGistry of Systemic Autoimmune and Autoinflammatory Diseases
An observational study of Behcet Disease and Antineutrophil Cytoplasmic Antibody (ANCA) Positive Vasculitis, run by Santé Arménie French-Armenian Research Center at 6 sites in Armenia.
Trial summary
Longitudinal prospective multicenter Armenian registry of systemic autoimmune, autoinflammatory diseases with constitution of bio-banking. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Behcet Disease, Antineutrophil Cytoplasmic Antibody (ANCA) Positive Vasculitis, Takayasu Arteritis
- What is being tested?
- Usual medical management of patients, additional blood and stool samples for biobanking
- How many people
- 800 participants
- Where
- 6 sitesArmenia
- Study dates
- 21 Jun 2023to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Outpatients and inpatients at participating centers, major and minor patients with a confirmed diagnosis of at least one of autoimmune systemic diseases
Who may be able to join
- 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
Who cannot join
- Patients refusing to participate in the registry
- Non-consent from legal representative
- Breastfeeding or pregnant patients
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Armenia6 sites, 6 recruiting
- Recruiting
Hematology Center after Prof.R.H. Yeolyan
Yerevan, 0014
Liana Hambardzumyan, Dr., lianahambardzumyan00@gmail.com
Liana Hambardzumyan, Dr.
- Recruiting
Nairi Medical Center, Rheumatology Department
Yerevan, 0015
Vahan Mukuchayn, Dr., vmukuchyan@gmail.com
Vahan Mukuchyan, Dr.
- Not yet recruiting
Heratsi Hospital Complex n°1, Rheumatology Department
Yerevan, 0025
Knarik Ginosyan, Dr., kginosyan@gmail.com
Merry Mazmanian, Dr., merry.mazmanian@santearmenie.org
- Recruiting
Heratsi Hospital Complex №1, Allergology Department
Yerevan, 0025
Armine Hakobyan, Dr., arminehakobyan.v@gmail.com
Armine Hakobyan, Dr.
- Recruiting
Mikaelyan Institute of Surgery, Rheumatology Department
Yerevan, 0052
Valentina Vardanyan, Dr., +37499066115, valentina.vardanyan@gmail.com
Valentina Vardanyan, Dr.
- Not yet recruiting
Erebouni Medical Center, Rheumatology Department
Yerevan, 0087
Armine Haroyan, Dr.
Magda Osipyan, Dr.
About this study
Official title: Armenian Nationwide Registry of Systemic Autoimmune and Autoinflammatory Diseases
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.
- Conditions
- Behcet Disease, Antineutrophil Cytoplasmic Antibody (ANCA) Positive Vasculitis, Takayasu Arteritis, Giant Cell Arteritis, Sjogren's Syndrome, Rheumatoid Arthritis
- Being tested
- Usual medical management of patients, additional blood and stool samples for biobanking
- Keywords
- arthritis, autoimmune, systemic, autoinflammatory, Behcet, Takayasu, Giant Cell, Angioedema, APS
- Medical subject headings
- Behcet Syndrome, Takayasu Arteritis, Giant Cell Arteritis, Sjogren's Syndrome, Arthritis, Rheumatoid, Acquired angioedema, Celiac Disease, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual medical management of patients, additional blood and stool samples for biobankingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Systemic autoimmune and autoinflammatory diseases | Not described Receives: Other: Usual medical management of patients, additional blood and stool samples for biobanking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, an average of 5 years
Secondary outcomes (2)
Identification of rare clinical forms
Clinical and biological correlations to characterize rare clinical forms of each pathology
Measured: 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.
Measured: Through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start21 Jun 2023
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behcet DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Santé Arménie French-Armenian Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Merry Mazmanian, Dr., Study director, Santé Arménie French - Armenian Academic Research Organization FAARO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904301
- Sponsor's protocol ID
- SA-2021001
- Acronym
- NAREG
- Status last verified
- Nov 2024
- First submitted
- 25 May 2023
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Armenian Nationwide Registry of Systemic Autoimmune and Autoinflammatory Diseases
- ClinicalTrials.gov ID
- NCT05904301
- Acronym / sponsor ID
- NAREG / SA-2021001
- Conditions
- Behcet Disease, Antineutrophil Cytoplasmic Antibody (ANCA) Positive Vasculitis, Takayasu Arteritis, Giant Cell Arteritis, Sjogren's Syndrome, Rheumatoid Arthritis
- Keywords
- arthritis, autoimmune, systemic, autoinflammatory, Behcet, Takayasu, Giant Cell, Angioedema
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Santé Arménie French-Armenian Research CenterUniversity, hospital or other
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Systemic autoimmune and autoinflammatory diseases | – | Other: Usual medical management of patients, additional blood and stool samples for biobanking |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Outpatients and inpatients at participating centers, major and minor patients with a confirmed diagnosis of at least one of autoimmune systemic diseases
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients refusing to participate in the registry
- Non-consent from legal representative
- Breastfeeding or pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual medical management of patients, additional blood and stool samples for biobankingFor 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. | Other | Systemic autoimmune and autoinflammatory diseases |
Primary outcome
Systemic manifestations and evolution of the diseases under treatment by disease-specific activity scores
Time frame: Through study completion, an average of 5 years
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
2 secondary outcomes
Identification of rare clinical forms
Time frame: Through study completion, an average of 5 years
Prognostic factors of the diseases
Time frame: Through study completion, an average of 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Merry Mazmanian, Dr. study director
Santé Arménie French - Armenian Academic Research Organization FAARO
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Behcet Disease and Antineutrophil Cytoplasmic Antibody (ANCA) Positive Vasculitis, run by Santé Arménie French-Armenian Research Center at 6 sites in Armenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Armenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arsene Mekinian, Prof. (01 49 28 23 92 ext. +33, arsene.mekinian@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic manifestations and evolution of the diseases under treatment by disease-specific activity scores (time frame: Through study completion, an average of 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.