Clinical trial NCT01584778: Behçet's Disease and Eosinophil Cationic Protein
Official title: The Serum Eosinophil Cationic Protein Levels in Behçet's Disease and Its Relation to the Clinical Activity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Behçet's Disease
Keywords: Behçet's disease
Eosinophil cationic protein
Eosinophils
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2012-04-25
Enrollment: 47
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive Behçet patients of the outpatient clinic of the Rheumatology-Immunology Department of University Hospital

Brief summary: Eosinophil cationic protein (ECP) is a matrix protein of eosinophils and has been reported to reflect eosinophil activity. Few studies have examined the role of eosinophils in the pathogenesis of Behçet's disease. The purpose of the present study is to investigate the serum ECP levels in BD and its relation to clinical activity.

Detailed description: Behçet's disease (BD) is a systemic vasculitis, characterized by recurrent oral aphthae, genital ulcers, uveitis, skin lesions, arthritis, gastrointestinal and neurologic manifestations. There has been a growing interest in research on the pathogenesis of the disease. Eosinophils has been implicated in the vascular injury associated with several vasculitis syndromes like Churg Strauss syndrome, temporal arteritis and Henoch-Schonlein purpura. In Behçet patients, serum IgE and eosinophils have been reported to be comparable with the controls but eosinophil activity has not been studied extensively. Eosinophil cationic protein (ECP) is a matrix protein of specific granules of eosinophils with considerable capacity to damage tissue and cells and has been reported to reflect eosinophil activity. Increased serum levels of ECP has been reported in patients with seasonal allergic rhinitis. Several immunomodulatory features of ECP has been reported, such as inhibition of the proliferative T-lymphocyte response to antigen, immunoglobulin production, proliferation of plasma cell lines and upregulation of ICAM-1. Procoagulant effects of ECP has also been reported. The present study was conducted in patients without usage of any confounding drugs that can effect serum ECP levels. The purpose of this study was to investigate the serum ECP levels in BD and its relation to the clinical activity.

Forty-seven consecutive patients with BD (22 active, 25 inactive) meeting International Study Group Criteria , 21 age and sex matched patients with allergic rhinitis and 21 apparently healthy controls were evaluated prospectively in Rheumatology-Immunology Outpatient Clinic. Clinical activity was defined according to the criteria proposed by "Behcet's Disease Research Committee of Japan" . Activity scoring was made according to the "Behçet's Disease Research Committee of Japan" which was proposed in 1994. Organ involvements of the patients were summarized.

Patients on corticosteroids or immunosuppressives were excluded. Colchicine was stopped 10 days prior to the blood collection in inactive patients. Blood was drawn from the active patients before starting treatment. Cases with any allergy history or parasitosis were excluded.

Eligibility criteria: Inclusion Criteria:

* Consecutive Behçet patients who gave the written informed consent were included.

Exclusion Criteria:

* Patients on corticosteroids or immunosuppressives were excluded.Cases with any allergy history or parasitosis were excluded.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University, Faculty of Medicine, Rheumatology-Immunology Department
Study officials:
affiliation: Cukurova University, Faculty of Medicine, Rheumatology-Immunology Department
name: Hüseyin TE Ozer, Assoc. Prof.
role: STUDY_CHAIR
affiliation: Cukurova University, Faculty of Medicine, Rheumatology-Immunology Department
name: Eren Erken, Prof. Dr.
role: STUDY_DIRECTOR
References: