NCT07073261

Brief Summary

PROBE is an observational multicenter cohort study, consisting of a cross-sectional and a 5-years prospective phase, designed to target the major study objectives, such as testing the comprehensiveness of the Behçet's syndrome Overall Damage Index (BODI) in a wide and ethnically heterogeneous cohort of Behçet's syndrome patients, and investigating how damage assessed by the BODI correlates with other major long-term disease outcomes (5-years mortality and hospitalization rates).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
970

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Jul 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Jul 2021Dec 2027

Study Start

First participant enrolled

July 23, 2021

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 18, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

6.4 years

First QC Date

June 27, 2025

Last Update Submit

July 9, 2025

Conditions

Behçet's Syndrome (BS)

Keywords

PROBEBehçet's syndromeDamageBehçet's syndrome Overall Damage IndexBODIGeographic variabilityDamage accrualHospitalizationMortality

Outcome Measures

Primary Outcomes (2)

  • 5-years mortality rate

    Correlation between the irreversible organ damage measured by the BEhçet's syndrome Overall Damage Index (BODI) and the 5-years mortality rate.

    5 years

  • 5-years hospitalization rate

    Correlation between the irreversible organ damage measured by the BEhçet's syndrome Overall Damage Index (BODI) and the 5-years hospitalization rate.

    5 years

Secondary Outcomes (2)

  • Organ damage accrual measured by the BEhçet's syndrome Overall Damage Index (BODI)

    5 years

  • Differences in annual rate of increase in organ damage in patients coming from different geographical areas.

    5 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of consecutive Behçet's syndrome (BS) patients, coming from 11 different countries, diagnosed according to the ICBD or ISG classification criteria, recruited in Centers with expertise for BS.

You may qualify if:

  • Diagnosis of BS according to ICBD or ISG criteria.

You may not qualify if:

  • Subjects unable or unwilling to make themselves available for the duration of the study and/or are unwilling to follow interval visits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rheumatology Unit, University and AOU of Cagliari

Monserrato, Cagliari, 09042, Italy

Location

MeSH Terms

Conditions

Behcet Syndrome

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesUveitis, AnteriorPanuveitisUveitisUveal DiseasesEye DiseasesVasculitisVascular DiseasesCardiovascular DiseasesHereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Vascular

Study Officials

  • Matteo Piga, Medicine and Surgery

    University of Cagliari

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Rheumatology

Study Record Dates

First Submitted

June 27, 2025

First Posted

July 18, 2025

Study Start

July 23, 2021

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

July 18, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Locations

IT(1)