Serum EBI-3 Protein Levels in Behçet's Disease

NCT07845162 — Not yet recruiting, 90 participants, Assiut University

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Serum Epstein-Barr Virus-induced Gene 3 Protein Levels in Patients With Behçet's Disease

Registry	NCT07845162
Status	Not yet recruiting
Study type	Observational
Enrollment	90 (Estimated)
Sponsor	Assiut University (Other)
Conditions	Behçet Disease
Dates	start 2026-09-26 (estimated), primary completion 2027-09-26 (estimated), completion 2028-01-25 (estimated), first posted 2026-09-28, last updated 2026-09-28

-Summary

This cross-sectional study aims to evaluate serum Epstein-Barr virus-induced gene 3 (EBI-3) protein levels in patients with Behçet's disease compared with healthy controls.

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+Detailed description

Behçet's disease is a chronic multisystem inflammatory disorder. Serum EBI-3 protein levels may reflect inflammatory activity.

This observational study will include adult patients diagnosed with Behçet's disease according to the International Criteria for Behçet's Disease and age-matched healthy controls. Serum EBI-3 protein levels will be measured by ELISA.

+Arms and interventions

Arm	Type	Interventions	Description
Behçet's Disease			Patients diagnosed with Behçet's disease according to the International Criteria for Behçet's Disease.
Healthy Controls			Age-matched healthy individuals without autoimmune or inflammatory diseases.

+Outcome measures

Primary outcomes

Mean serum EBI-3 protein level [Baseline]: Mean serum Epstein-Barr virus-induced gene 3 (EBI-3) protein concentration measured by ELISA in patients with Behçet's disease compared with healthy controls.

Secondary outcomes

Serum EBI-3 level according to disease activity [Baseline]: Mean serum EBI-3 protein concentration according to Behçet's Disease Current Activity Form (BDCAF) score.
Serum EBI-3 level in patients with vascular involvement [Baseline]: Mean serum EBI-3 protein concentration in patients with and without vascular involvement
Serum EBI-3 level in patients with ocular involvement [Baseline]: Mean serum EBI-3 protein concentration in patients with and without ocular involvement.
Serum EBI-3 level in patients with neurological involvement [Baseline]: Mean serum EBI-3 protein concentration in patients with and without neurological involvement.

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* \- Age 18 years or older
* Diagnosis of Behçet's disease according to the International Criteria for Behçet's Disease (cases)
* Healthy individuals without autoimmune or inflammatory diseases (controls)
* Written informed consent

Exclusion Criteria:

* \- Other autoimmune disorders (RA, SLE, psoriatic arthritis, ankylosing spondylitis)
* Acute or chronic infection
* Malignancy or history of malignancy
* Chronic liver disease or advanced chronic kidney disease
* Pregnancy or lactation
* Vasculitis caused by diseases other than Behçet's disease

+Investigators

Gehan I Abdelraziq, prof, Study chair, Physical Medicine, Rheumatology and Rehabilitation Department, Assiut University Hospitals