Behçet Disease Clinical Trial
— BODIOfficial title:
Development and Preliminary Validation of the Behçet's Disease Overall Damage Index
NCT number | NCT03803462 |
Other study ID # | BODI |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 1, 2017 |
Est. completion date | December 2019 |
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).
Status | Recruiting |
Enrollment | 210 |
Est. completion date | December 2019 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - unable to adhere to the protocol requirements. |
Country | Name | City | State |
---|---|---|---|
Greece | Department of Rheumatology, Clinical Immunology and Allergy, University of Crete | Heraklion | |
Italy | Rheumatology Unit, University of Bari | Bari | |
Italy | Rheumatology Unit, Department of Clinical Sciences, AOU Sant'Anna University of Ferrara | Ferrara | |
Italy | Patient Association Delegates | Iglesias | |
Italy | Azienda Ospedaliero Universitaria Cagliari | Monserrato | |
Italy | Rheumatology Unit, Policlinico Le Scotte, University of Siena | Siena | |
Portugal | Clinical Immunology Unit, Centro Hospitalar do Porto, Universidade do Porto | Porto | |
Portugal | Neurology Department, Hospital Santo Antonio, Centro Hospitalar do Porto | Porto | |
Spain | Department of Autoimmune Diseases, Hospital Clinic, University of Barcelona | Barcelona | |
United Arab Emirates | Eye Institute at Cleveland Clinic | Abu Dhabi |
Lead Sponsor | Collaborator |
---|---|
University of Cagliari |
Greece, Italy, Portugal, Spain, United Arab Emirates,
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. — View Citation
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 Behçet Disease: Report from OMERACT 2016. J Rheumatol. 2017 Nov;44(11):1750-1753. doi: 10.3899/jrheum.161352. Epub 2017 Apr 1. — View Citation
Hatemi G, Merkel PA, Hamuryudan V, Boers M, Direskeneli H, Aydin SZ, Yazici H. Outcome measures used in clinical trials for Behçet syndrome: a systematic review. J Rheumatol. 2014 Mar;41(3):599-612. doi: 10.3899/jrheum.131249. Epub 2014 Feb 1. Review. — View Citation
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. — View Citation
Piga M, Mathieu A. The origin of Behçet'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. Review. — View Citation
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, Landewé 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Behçet's disease Overall Damage Index | Prevalence and type of organ damage in Behçet's Disease assessed by experimental tool | Baseline | |
Secondary | Vasculitis Damage Index | Prevalence and type of organ damage in Behçet's Disease assessed by non specific tool different | Baseline | |
Secondary | Disease activity (Behçet disease actvity form) | Prevalence and level of disease activity | Baseline | |
Secondary | Health Related Quality of Life (HRQoL) | Health Related Quality of Life measured by the eight scaled scores of the SF-36: 1) vitality; 2) physical functioning; 3) bodily pain; 4) general health perceptions; 5) physical role functioning; 6) emotional role functioning; 7) social role functioning; 8) mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability | Baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04528082 -
Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease
|
Phase 3 | |
Recruiting |
NCT04101604 -
Biomarkers of Common Eye Diseases
|
||
Terminated |
NCT04609397 -
A Study to Evaluate the Efficacy and Safety of Hemay005 in the Treatment of Behçet Disease
|
Phase 2 | |
Not yet recruiting |
NCT05128357 -
IMPACT_BD (IMProving AdherenCe to Treatment in Behçet's Disease)
|
||
Not yet recruiting |
NCT04126850 -
Pilot Project: The Amplicon and Metatranscriptomic Study of Intra and Extra Intestinal Microbiome in Non-infectious Uveitis Disease
|
||
Recruiting |
NCT05879419 -
Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases
|
Phase 4 | |
Completed |
NCT03209219 -
Interferon α2a Versus Cyclosporine for Refractory Behçet's Disease Uveitis
|
Phase 3 | |
Completed |
NCT04386824 -
Erectile Dysfunction in Patients With Non Ocular Behçet's Disease
|
||
Completed |
NCT02648581 -
Efficacy and Safety of Ustekinumab, a Human Monoclonal Anti-IL-12/IL-23 Antibody, in Patients With Behçet Disease
|
Phase 2 | |
Recruiting |
NCT06451575 -
Thrombophilia and Thrombosis in Behçet's Disease
|
||
Recruiting |
NCT04530461 -
Serologic Profile of SARS CoV2 in COVID-19 Patients With Systemic Diseases
|
||
Not yet recruiting |
NCT06386744 -
Dusquetide for the Treatment of Behcet's Disease
|
Phase 2 | |
Recruiting |
NCT04334031 -
Deployment o the Multidisciplinary Prospective Cohort Imminent
|
N/A | |
Not yet recruiting |
NCT04105439 -
Plasma Soluble Urokinase Plasminogen Activator Receptor and Behçet's Disease .
|
||
Not yet recruiting |
NCT05715294 -
The Effect of Music on Sleep Quality in Behçet's Patients
|
N/A | |
Active, not recruiting |
NCT06266247 -
How Sirtuin Levels Change During Behçet Disease
|
N/A | |
Recruiting |
NCT04959435 -
Understanding the Role of Oral Microbiota in Behçet's Disease (BEHCETBIOT)
|
||
Recruiting |
NCT03837236 -
Inactivity Behavior and Exercise Bariers in Patients With Behçet Disease
|
N/A |