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Behçet's Disease Overall Damage Index

NCT03803462 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 210

Last updated 2019-01-15

No results posted yet for this study

Summary

Damage in vasculitis, as well as in other chronic inflammatory disorders, accrues over time resulting in impairment of quality of life, development of disability and increased mortality. For these reasons, damage represents an important outcome to be assessed and measured both in trials and clinical practice.

Currently, the most widely used assessment tool for damage in vasculitis is the Vasculitis Damage Index (VDI). However, VDI was developed for a no specific type of vasculitis and it appears to be more suitable for damage assessment in ANCA-associated vasculitis than in Behçet' disease (BD).

BD is a chronic and multisystem inflammatory disorder classified among vasculitides. As well as in other vasculitides, disease activity and treatment in BD can result in the development and accumulation of irreversible organ damage, such as blindness, tissue loss and a wide range of neurologic disorders. Recently the OMERACT has defined the Core Set domain of Outcome Measures for BD. Despite damage is included in the OMERACT outcome core set for rheumatic disease, a specific assessment tool for BD is currently not available.

The aim of this study is to develop and validate the first tool for describing and measuring organ damage in patients with Behçet Disease (Behçet's disease Overall Damage index - BODI).

Conditions

  • Behçet Disease
  • Behcet's Disease Aggravated

Interventions

OTHER

Behçet's disease Overall Damage Index (BODI)

BODI is a tool to document any organ damage that has occurred in patients since the onset of BD. It includes a form and an associated glossary with the definition of the items.

Sponsors & Collaborators

  • University of Cagliari

    lead OTHER

Principal Investigators

  • Matteo Piga, MD · Azienda Ospedaliero Universitaria Cagliari

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2019-06-30
Completion
2019-12-31

Countries

  • Greece
  • Italy
  • Portugal
  • Spain
  • United Arab Emirates

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03803462 on ClinicalTrials.gov