Nationwide registry for systemic autoimmune and autoinflammatory diseases in Armenia
Armenian Nationwide Registry of Systemic Autoimmune and Autoinflammatory Diseases
This study is trying to gather information about systemic autoimmune and autoinflammatory diseases in Armenia to better understand how these conditions progress and how they are treated.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Sex | All |
| Sponsor | Santé Arménie French-Armenian Research Center Academic / other |
| Locations | 6 sites (Yerevan and 5 other locations) |
| Trial ID | NCT05904301 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a longitudinal prospective registry of systemic autoimmune and autoinflammatory diseases in Armenia, focusing on conditions such as Behcet Disease and ANCA-positive vasculitis. The registry will involve the usual medical management of patients along with the collection of additional blood and stool samples for biobanking. By documenting the epidemiological elements and treatment variations across different centers, the study seeks to enhance understanding and management of these complex diseases. The initiative is expected to contribute valuable data on disease progression and treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients with a confirmed diagnosis of specific autoimmune systemic diseases such as Behcet disease, ANCA-positive vasculitis, and Sjogren's syndrome.
Not a fit: Patients who are breastfeeding or pregnant, or those who refuse to participate, may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could improve the understanding and management of systemic autoimmune diseases, leading to better patient outcomes.
How similar studies have performed: While similar registries have been established in other regions, this specific approach in Armenia is novel and aims to fill a significant knowledge gap.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Yerevan and 5 other locations
- Hematology Center after Prof.R.H. Yeolyan — Yerevan, Armenia (Recruiting)
- Nairi Medical Center, Rheumatology Department — Yerevan, Armenia (Recruiting)
- Heratsi Hospital Complex n°1, Rheumatology Department — Yerevan, Armenia (Not_yet_recruiting)
- Heratsi Hospital Complex №1, Allergology Department — Yerevan, Armenia (Recruiting)
- Mikaelyan Institute of Surgery, Rheumatology Department — Yerevan, Armenia (Recruiting)
- Erebouni Medical Center, Rheumatology Department — Yerevan, Armenia (Not_yet_recruiting)
Study contacts
- Study coordinator: Arsene Mekinian, Prof.
- Email: arsene.mekinian@aphp.fr
- Phone: 01 49 28 23 92
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.