- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01584778
Behçet's Disease and Eosinophil Cationic Protein
The Serum Eosinophil Cationic Protein Levels in Behçet's Disease and Its Relation to the Clinical Activity
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Adana, Turkey, 01330
- Cukurova University, Faculty of Medicine, Rheumatology-Immunology Department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy controls
|
Serum eosinophil cationic protein levels
Other Names:
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Behçet patients
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Serum eosinophil cationic protein levels
Other Names:
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Allergic rhinitis (diseased) controls
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Serum eosinophil cationic protein levels
Other Names:
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Hüseyin TE Ozer, Assoc. Prof., Cukurova University, Faculty of Medicine, Rheumatology-Immunology Department
- Study Director: Eren Erken, Prof. Dr., Cukurova University, Faculty of Medicine, Rheumatology-Immunology Department
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Eye Diseases
- Genetic Diseases, Inborn
- Stomatognathic Diseases
- Mouth Diseases
- Uveitis, Anterior
- Panuveitis
- Uveitis
- Uveal Diseases
- Vasculitis
- Hereditary Autoinflammatory Diseases
- Skin Diseases, Genetic
- Skin Diseases, Vascular
- Behcet Syndrome
- Physiological Effects of Drugs
- Immunologic Factors
- Eosinophil Cationic Protein
Other Study ID Numbers
- TF.00.U.32.
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