Behçet's Disease Overall Damage Index

NCT03803462 | Unknown

• 1 other identifier: BODI
• Study Type: observational
• Target: 210
• Locations: 5 countries
• Sites: 10

Brief 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

Keywords

Damage; Outcome measure

Outcome Measures

Primary Outcomes (1)

• Behçet's disease Overall Damage Index

  Prevalence and type of organ damage in Behçet's Disease assessed by experimental tool

  Baseline

Secondary Outcomes (3)

• Vasculitis Damage Index

  Baseline

• Disease activity (Behçet disease actvity form)

  Baseline

• Health Related Quality of Life (HRQoL)

  Baseline

Interventions

Behçet's disease Overall Damage Index (BODI) OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A multicenter cohort consisting of 200-250 consecutive BD patients. Each participating investigator will enroll a cohort of 20-30 BD patients consecutively assessed in its own center.

You may qualify if:

• BD diagnosis according to ICBD criteria;
• disease duration ≥12 months;
• age at enrolment ≥ 18 years;
• Able to understand and voluntarily sign informed consent forms (ICFs) prior to the initiation of any study-specific assessments/procedures.

You may not qualify if:

• unable to adhere to the protocol requirements.

Sponsors & Collaborators

• University of Cagliari: lead

Study Sites (10)

Department of Rheumatology, Clinical Immunology and Allergy, University of Crete

Heraklion, Greece

RECRUITING

Rheumatology Unit, University of Bari

Bari, Italy

RECRUITING

Rheumatology Unit, Department of Clinical Sciences, AOU Sant'Anna University of Ferrara

Ferrara, Italy

RECRUITING

Patient Association Delegates

Iglesias, Italy

ACTIVE NOT RECRUITING

Azienda Ospedaliero Universitaria Cagliari

Monserrato, 09042, Italy

RECRUITING

Rheumatology Unit, Policlinico Le Scotte, University of Siena

Siena, Italy

RECRUITING

Clinical Immunology Unit, Centro Hospitalar do Porto, Universidade do Porto

Porto, Portugal

RECRUITING

Neurology Department, Hospital Santo Antonio, Centro Hospitalar do Porto

Porto, Portugal

RECRUITING

Department of Autoimmune Diseases, Hospital Clinic, University of Barcelona

Barcelona, Spain

RECRUITING

Eye Institute at Cleveland Clinic

Abu Dhabi, United Arab Emirates

ACTIVE NOT RECRUITING

Related Publications (6)

• Hatemi G, Merkel PA, Hamuryudan V, Boers M, Direskeneli H, Aydin SZ, Yazici H. Outcome measures used in clinical trials for Behcet syndrome: a systematic review. J Rheumatol. 2014 Mar;41(3):599-612. doi: 10.3899/jrheum.131249. Epub 2014 Feb 1.

  PMID: 24488418 BACKGROUND

• Hatemi G, Meara A, Ozguler Y, Direskeneli H, Mahr A, Easley E, Gurcan M, Davis T, Gul A, Yazici Y, Zottenberg K, Esatoglu SN, Erer B, Kamali S, Yazici H, Cronholm PF, Merkel PA. Developing a Core Set of Outcome Measures for Behcet Disease: Report from OMERACT 2016. J Rheumatol. 2017 Nov;44(11):1750-1753. doi: 10.3899/jrheum.161352. Epub 2017 Apr 1.

  PMID: 28365574 BACKGROUND

• Piga M, Mathieu A. The origin of Behcet's disease geoepidemiology: possible role of a dual microbial-driven genetic selection. Clin Exp Rheumatol. 2014 Jul-Aug;32(4 Suppl 84):S123-9. Epub 2014 Jan 20.

  PMID: 24447390 BACKGROUND

• Kirwan JR, Boers M, Tugwell P. Updating the OMERACT filter at OMERACT 11. J Rheumatol. 2014 May;41(5):975-7. doi: 10.3899/jrheum.131306.

  PMID: 24788466 BACKGROUND

• Wells G, Beaton DE, Tugwell P, Boers M, Kirwan JR, Bingham CO 3rd, Boonen A, Brooks P, Conaghan PG, D'Agostino MA, Dougados M, Furst DE, Gossec L, Guillemin F, Helliwell P, Hewlett S, Kvien TK, Landewe RB, March L, Mease PJ, Ostergaard M, Simon L, Singh JA, Strand V, van der Heijde DM. Updating the OMERACT filter: discrimination and feasibility. J Rheumatol. 2014 May;41(5):1005-10. doi: 10.3899/jrheum.131311. Epub 2014 Apr 1.

  PMID: 24692522 BACKGROUND

• Exley AR, Bacon PA, Luqmani RA, Kitas GD, Gordon C, Savage CO, Adu D. Development and initial validation of the Vasculitis Damage Index for the standardized clinical assessment of damage in the systemic vasculitides. Arthritis Rheum. 1997 Feb;40(2):371-80. doi: 10.1002/art.1780400222.

  PMID: 9041949 BACKGROUND

MeSH Terms

Conditions

Behcet Syndrome

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular

Study Officials

• Matteo Piga, MD

  Azienda Ospedaliero Universitaria Cagliari

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matteo Piga, MD

CONTACT

+390706754069; matteopiga@unica.it

Alberto Floris, MD

CONTACT

+3907051093348; albertofloris1@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 14, 2019
• Study Start: August 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 15, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: .Within 6 months of study completion.
• Access Criteria: Upon request

Locations

IT (5); AE (1); GR (1); PT (2); ES (1)