Armenian NAtionwide REGistry of Systemic Autoimmune and Autoinflammatory Diseases

Rheumatoid Arthritis Clinical Trial

— NAREG  

Official title:

Armenian Nationwide Registry of Systemic Autoimmune and Autoinflammatory Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05904301
• Other study ID #: SA-2021001
• Status: Recruiting
• Start date: June 21, 2023
• Est. completion date: June 30, 2028

Study information

• Verified date: June 2023
• Source: Santé Arménie French-Armenian Research Center
• Contact: Arsene Mekinian, Prof.
• Phone: 01 49 28 23 92
• Email: arsene.mekinian[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: June 30, 2028
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Angioedema
• Antiphospholipid Syndrome
• Arteritis
• Arthritis
• Behcet Disease
• Behcet Syndrome
• Celiac Disease
• Giant Cell Arteritis
• Polymyalgia Rheumatica
• Primary Antiphospholipid Syndrome
• Rheumatoid Arthritis
• Sjogren's Syndrome
• Syndrome
• Takayasu Arteritis
• Vasculitis

Intervention

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.

Locations

Country	Name	City	State
Armenia	Erebouni Medical Center, Rheumatology Department	Yerevan
Armenia	Heratsi Hospital Complex n°1, Rheumatology Department	Yerevan
Armenia	Nairi Medical Center, Rheumatology Department	Yerevan

Sponsors (1)

Lead Sponsor	Collaborator
Santé Arménie French-Armenian Research Center

Country where clinical trial is conducted

Armenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Through study completion, an average of 5 years
Secondary	Identification of rare clinical forms	Clinical and biological correlations to characterize rare clinical forms of each pathology	Through study completion, an average of 5 years
Secondary	Prognostic factors of the diseases	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