Immunogenetic Mechanisms in Behcet's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01109433|
Recruitment Status : Recruiting
First Posted : April 23, 2010
Last Update Posted : March 29, 2018
|First Submitted Date||April 22, 2010|
|First Posted Date||April 23, 2010|
|Last Update Posted Date||March 29, 2018|
|Study Start Date||April 15, 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||Establishing evidence for serum biomarkers associated with BD and establishing demethylation differences between ocular and non-ocular BD participants and controls. [ Time Frame: Ongoing ]|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT01109433 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures
||To explore associations between disease severity and treatment response with observed epigenetic modifications and biomarkers. [ Time Frame: Ongoing ]|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Immunogenetic Mechanisms in Behcet's Disease|
|Official Title||Immunogenetic Mechanisms in Behcet's Disease|
- Uveitis, the inflammation of the interior of the eye, is responsible for numerous new cases of legal blindness every year. Uveitis can be caused by Beh(SqrRoot)(Beta)et s disease (BD), a chronic inflammatory disorder that can affect the eye, mucous membranes, and other body organs such as the joints, intestinal tract, blood vessels, and central nervous system.
The purpose of this study is to see how genes affect Beh(SqrRoot)(Beta)et s disease and if there are differences in Beh(SqrRoot)(Beta)et s disease among people of different backgrounds.
Uveitis is responsible for approximately 30,000 cases of new legal blindness in the United States and 2.8-10% of all cases of blindness. Beh(SqrRoot)(Beta)et s disease (BD) is a chronic relapsing multisystem inflammatory disorder of unknown etiology that is characterized by intraocular inflammation, oral and mucosal ulcerations, cutaneous lesions and inflammation that may affect other body organs such as the joints, intestinal tract, epididymis, blood vessels and the central nervous system (2). The need for a safer and more effective therapy for patients with ocular manifestations of BD refractory to or intolerant of systemic immunosuppressive therapy warrants further investigation. Reports define a specific role for interleukin (IL)-17A in the pathogenesis of Beh(SqrRoot)(Beta)et s disease.
This protocol will evaluate immune mediators including cytokine profiles (soluble and intracellular), lymphocyte phenotyping and regulatory T-cells in participants with BD. Epigenetic modifications will also be studied.
Additionally, it has been suggested that American/Western BD patients may have different disease characteristics than their Mediterranean counterparts. The disease characteristics of American/Western and Mediterranean BD patients will be compared and evaluated. Blood samples from BD participants that have participated in other NIH protocols where participants consented for other or future use of samples has been obtained will be collected (particularly from current participants of NIH protocol 03-AR-0173 in which NEI is a collaborator). In summary, the results will be analyzed with respect to disease in different ethnic groups, and clinical features of the disease (e.g., ocular vs. non-ocular involvement, active vs. quiescent disease).
Anonymous blood samples (matched for race, age and sex) will be obtained from the NIH clinical center (CC) blood bank and will be compared to the diseased samples.
|Study Design||Observational Model: Case-Control
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Estimated Enrollment
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
One of the following must be true:
Eligible participants who do not wish to donate their blood sample or undergo a blood draw for the purposes of this research study.
|Ages||Child, Adult, Senior|
|Accepts Healthy Volunteers||No|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||100093
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )|
|Study Sponsor||National Eye Institute (NEI)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||December 22, 2017|