Health Trials

Armenian NAtionwide REGistry of Systemic Autoimmune and Autoinflammatory Diseases

ConditionsBehcet DiseaseAntineutrophil Cytoplasmic Antibody (ANCA) Positive VasculitisTakayasu ArteritisGiant Cell ArteritisSjogren's SyndromeRheumatoid ArthritisHereditary and Acquired AngioedemaPrimary Antiphospholipid SyndromeCeliac Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSanté Arménie French-Armenian Research Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: major and minor

Patients who have been informed and provided with written informed consent to participate Or consent from legal representative

Disqualifiers

Patients refusing to participate in the registry

Non-consent from legal representative

Breastfeeding or pregnant patients

Trial population

Outpatients and inpatients at participating centers, major and minor patients with a confirmed diagnosis of at least one of autoimmune systemic diseases

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

    Other intervention

    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.

Treatment groups

800 Participants
are divided into 1 treatment group
Group A: Systemic autoimmune and autoinflammatory diseases1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Santé Arménie French-Armenian Research Center

Lead sponsor

Source ClinicalTrials.gov
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