Armenian NAtionwide REGistry of Systemic Autoimmune and Autoinflammatory Diseases (NAREG)

June 26, 2023 updated by: Santé Arménie French-Armenian Research Center

Armenian Nationwide Registry of Systemic Autoimmune and Autoinflammatory Diseases

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Armenia
      • Yerevan, Armenia, 0015
        • Recruiting
        • Nairi Medical Center, Rheumatology Department
        • Contact:
        • Principal Investigator:
          • Vahan Mukuchyan, Dr.
      • Yerevan, Armenia, 0025
      • Yerevan, Armenia, 0087
        • Not yet recruiting
        • Erebouni Medical Center, Rheumatology Department
        • Principal Investigator:
          • Armine Haroyan, Dr.
        • Sub-Investigator:
          • Magda Osipyan, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Systemic autoimmune and autoinflammatory diseases
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of rare clinical forms
Time Frame: Through study completion, an average of 5 years
Clinical and biological correlations to characterize rare clinical forms of each pathology
Through study completion, an average of 5 years
Prognostic factors of the diseases
Time Frame: Through study completion, an average of 5 years
Interest in prognostic factors obtained through more targeted radiological examinations and correlation with the response to different treatments.
Through study completion, an average of 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Santé Arménie French-Armenian Research Center

Investigators

  • Study Director: Merry Mazmanian, Dr., Santé Arménie Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2023

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

May 25, 2023

First Submitted That Met QC Criteria

June 13, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 26, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SA-2021001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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