Behçet's DiseaseNCT07157189
Clinical, Laboratory, and Therapeutic Analysis of Behçet's Disease in Assiut
An observational study of Behçet's Disease, run by Assiut University.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Behçet's Disease
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible participants are adults 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). Patients with unconfirmed BD are excluded. Given BD's variable age and gender distribution, the population will reflect regional epidemiological trends, including a probable male predominance consistent with Arab and Mediterranean cohorts. Comprehensive sociodemographic data, disease duration, age at onset, family/personal history, and clinical presentation are documented. All patients are monitored through a structured two-year inclusion, maximizing sample heterogeneity and capturing real-world data from both inpatient and outpatient clinical pathways .
Who may be able to join
- 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)
Who cannot join
- Patients with unconfirmed diagnosis of BD.
About this study
Official title: Clinical, Laboratory and Therapeutic Profile of Behçet's Disease Patients in Tertiary Center in Upper Egypt
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
Read the 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 .
- Conditions
- Behçet's Disease
- Keywords
- Behçet's disease, therapeutic profile
- Medical subject headings
- Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Behçet's disease patients | adults 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of key clinical manifestations in Behçet's disease patients
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start30 Sep 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Behçet's DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Maher, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157189
- Sponsor's protocol ID
- Analysis of Behçet's Disease
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 39101633
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Laboratory and Therapeutic Profile of Behçet's Disease Patients in Tertiary Center in Upper Egypt
- ClinicalTrials.gov ID
- NCT07157189
- Acronym / sponsor ID
- Analysis of Behçet's Disease
- Conditions
- Behçet's Disease
- Keywords
- Behçet's disease, therapeutic profile
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behçet's disease patients | – | –adults 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible participants are adults 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). Patients with unconfirmed BD are excluded. Given BD's variable age and gender distribution, the population will reflect regional epidemiological trends, including a probable male predominance consistent with Arab and Mediterranean cohorts. Comprehensive sociodemographic data, disease duration, age at onset, family/personal history, and clinical presentation are documented. All patients are monitored through a structured two-year inclusion, maximizing sample heterogeneity and capturing real-world data from both inpatient and outpatient clinical pathways .
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- Patients with unconfirmed diagnosis of BD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of key clinical manifestations in Behçet's disease patients
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Background: PubMed 39101633Fazaa 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.
- Individual participant dataSharing planned: No
Related trials for Behçet's Disease
RecruitingPhase 3
A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
Behçet's Disease, Juvenile Psoriatic Arthritis
Not yet recruitingObservational study
Serum EBI-3 Protein Levels in Behçet's Disease
Behçet Disease
Not yet recruitingPhase 2
Corticotropin for Behçet's Disease: A Multicenter Randomized Controlled TrialAcronym.
Behçet's Syndrome, Behçet's Syndrome (BS)
RecruitingPhase 2
Baricitinib in the Treatment of Intestinal Behçet's Syndrome
Behcet Syndrome, Intestinal Type
RecruitingPhase 3
Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease
Behçet Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Behçet's Disease, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of key clinical manifestations in Behçet's disease patients (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07157189, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.