Clinical, Laboratory, and Therapeutic Analysis of Behçet's Disease in Assiut

NCT07157189 — Not yet recruiting, 30 participants, Assiut University

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Clinical, Laboratory and Therapeutic Profile of Behçet's Disease Patients in Tertiary Center in Upper Egypt

RegistryNCT07157189
StatusNot yet recruiting
Study typeObservational
Enrollment30 (Estimated)
SponsorAssiut University (Other)
ConditionsBehçet's Disease
Datesstart 2026-09-30 (estimated), primary completion 2027-11-30 (estimated), completion 2027-12-30 (estimated), first posted 2025-09-05, last updated 2025-09-05

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-Summary

A cross-sectional, observational study surveying the clinical, laboratory, and therapeutic characteristics of Behçet's disease patients in a tertiary care center in Upper Egypt

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+Detailed description

This research is designed to comprehensively characterize Behçet's disease (BD), an inflammatory multisystem disorder with variable prevalence and presentation based on geography and ethnicity. Data will be collected from patients attending the Rheumatology, Rehabilitation and Physical Medicine department, Assiut University Hospitals, capturing demographic profiles, disease manifestations, laboratory results, and therapeutic history. The study uses validated criteria (ISG and rICBD) for BD diagnosis, focusing on thorough examination across musculoskeletal, dermatological, ocular, vascular, gastrointestinal, and neurological domains. Disease activity and severity will be assessed using standardized forms (Behcet's disease current activity form 2006, BODI). Laboratory analysis includes CBC, acute phase reactants, and organ function tests. Data management incorporates advanced statistical techniques using SPSS, aiming for rigorous analysis to inform future BD management in the region .

+Arms and interventions

ArmTypeInterventionsDescription
Behçet's disease patientsadults and adolescents diagnosed using international criteria (ISG and rICBD), with recurrent oral ulceration and at least two additional manifestations (genital ulcers, eye lesions, skin lesions, positive pathergy test).

+Outcome measures

Primary outcomes

  • Proportion of key clinical manifestations in Behçet's disease patients [Baseline]: This outcome will systematically quantify how often major clinical features-such as recurrent oral ulcers, genital ulcers, ocular lesions (including chronic relapsing uveitis), and musculoskeletal involvement, appear within the studied Behçet's disease population, in accordance with predefined diagnostic criteria

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Patients who fulfil the international study group criteria (ISG) which require the presence of recurrent oral ulceration plus at least two of the following: recurrent genital ulcers, eye lesions (uveitis or retinal vasculitis), skin lesions, or a positive pathergy test (12). and the revised International Criteria of BD (rICBD)

Exclusion Criteria:

* Patients with unconfirmed diagnosis of BD.

+Publications

  • Fazaa A, Makhlouf Y, Ben Massoud F, Miladi S, Boussaa H, Ouenniche K, Souebni L, Kassab S, Chekili S, Ben Abdelghani K, Laatar A. Behcet disease: epidemiology, classification criteria and treatment modalities. Expert Rev Clin Immunol. 2024 Dec;20(12):1437-1448. doi: 10.1080/1744666X.2024.2388693. Epub 2024 Aug 11. PMID 39101633