Behçet's Disease and Eosinophil Cationic Protein

NCT ID: NCT01584778

Last Updated: 2012-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-01-31

Study Completion Date

2002-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Behçet's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Behçet patients

eosinophil cationic protein

Intervention Type OTHER

Serum eosinophil cationic protein levels

Healthy controls

eosinophil cationic protein

Intervention Type OTHER

Serum eosinophil cationic protein levels

Allergic rhinitis (diseased) controls

eosinophil cationic protein

Intervention Type OTHER

Serum eosinophil cationic protein levels

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

eosinophil cationic protein

Serum eosinophil cationic protein levels

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ECP

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cukurova University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Didem Arslan Tas

Dr. Didem Arslan Tas

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hüseyin TE Ozer, Assoc. Prof.

Role: STUDY_CHAIR

Cukurova University, Faculty of Medicine, Rheumatology-Immunology Department

Eren Erken, Prof. Dr.

Role: STUDY_DIRECTOR

Cukurova University, Faculty of Medicine, Rheumatology-Immunology Department

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cukurova University, Faculty of Medicine, Rheumatology-Immunology Department

Adana, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TF.00.U.32.

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

38 Week Extension Study to CAIN457C2303
NCT01093846 TERMINATED PHASE3