Behcet's DiseaseNCT01109433
Immunogenetic Mechanisms in Behcet's Disease
An observational study of Behcet's Disease and Uveitis, run by National Eye Institute (NEI) at 1 site in United States.
Trial summary
Background: 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Behcet's Disease, Uveitis
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2010to 17 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- One of the following must be true:
- Participants must have a diagnosis of BD according to the International Study Group for BD criteria or modified Japanese criteria, be enrolled in another NIH study and be willing to donate their blood for the purposes of this research study.
- Participants must be willing to have their blood stored for future/other research.
Who cannot join
- Eligible participants who do not wish to donate their blood sample or undergo a blood draw for the purposes of this research study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Background:
- 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.
Read more
Objectives:
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.
Eligibility:
- Individuals who have a diagnosis of BD and are enrolled in another NIH study.
- Individuals who are willing to donate blood for the purposes of this research study and who are willing to have their blood stored for possible future/other research purposes.
Design:
- As part of the study, blood samples will be drawn from participants when an exacerbation in disease activity occurs and before and after any significant change in treatment for BD.
- No treatments will be provided in this study.
Read the detailed description
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.
- Conditions
- Behcet's Disease, Uveitis
- Keywords
- Behcet's Disease, Intermediate Uveitis, Uveitis, Immunogenetics
- Medical subject headings
- Behcet Syndrome, Uveitis, Uveitis, Intermediate
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishing evidence for serum biomarkers associated with BD and establishing demethylation differences between ocular and non-ocular BD participants and controls.
Measured: Ongoing
Secondary outcomes (1)
To explore associations between disease severity and treatment response with observed epigenetic modifications and biomarkers.
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study start15 Apr 2010
- Study completion17 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Behcet's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Hatice N Sen, M.D., Principal investigator, National Eye Institute (NEI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109433
- Sponsor's protocol ID
- 100093
- Other IDs
- 10-EI-0093
- Status last verified
- 17 Dec 2018
- First submitted
- 22 Apr 2010
- Last updated
- 4 Nov 2019
- Results posted
- No
Publications
Gritz DC, Wong IG. Incidence and prevalence of uveitis in Northern California; the Northern California Epidemiology of Uveitis Study. Ophthalmology. 2004 Mar;111(3):491-500; discussion 500. doi: 10.1016/j.ophtha.2003.06.014.
PubMed 15019324Chamberlain MA. Behcet's syndrome in 32 patients in Yorkshire. Ann Rheum Dis. 1977 Dec;36(6):491-99. doi: 10.1136/ard.36.6.491.
PubMed 596943Jankowski J, Crombie I, Jankowski R. Behcet's syndrome in Scotland. Postgrad Med J. 1992 Jul;68(801):566-70. doi: 10.1136/pgmj.68.801.566.
PubMed 1437955
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenetic Mechanisms in Behcet's Disease
- ClinicalTrials.gov ID
- NCT01109433
- Acronym / sponsor ID
- 100093
- Conditions
- Behcet's Disease, Uveitis
- Keywords
- Behcet's Disease, Intermediate Uveitis, Uveitis, Immunogenetics
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 15 Apr 2010
- Study completion
- 17 Dec 2018
- First posted
- 23 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- 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.
Objectives:
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.
Eligibility:
- Individuals who have a diagnosis of BD and are enrolled in another NIH study.
- Individuals who are willing to donate blood for the purposes of this research study and who are willing to have their blood stored for possible future/other research purposes.
Design:
- As part of the study, blood samples will be drawn from participants when an exacerbation in disease activity occurs and before and after any significant change in treatment for BD.
- No treatments will be provided in this study.
Detailed description
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
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must have a diagnosis of BD according to the International Study Group for BD criteria or modified Japanese criteria, be enrolled in another NIH study and be willing to donate their blood for the purposes of this research study.
- Participants must be willing to have their blood stored for future/other research.
Key exclusion criteria (1 listed)
- Eligible participants who do not wish to donate their blood sample or undergo a blood draw for the purposes of this research study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Establishing evidence for serum biomarkers associated with BD and establishing demethylation differences between ocular and non-ocular BD participants and controls.
Time frame: Ongoing
1 secondary outcome
To explore associations between disease severity and treatment response with observed epigenetic modifications and biomarkers.
Time frame: Ongoing
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Background: PubMed 15019324Gritz DC, Wong IG. Incidence and prevalence of uveitis in Northern California; the Northern California Epidemiology of Uveitis Study. Ophthalmology. 2004 Mar;111(3):491-500; discussion 500. doi: 10.1016/j.ophtha.2003.06.014.
- Background: PubMed 596943Chamberlain MA. Behcet's syndrome in 32 patients in Yorkshire. Ann Rheum Dis. 1977 Dec;36(6):491-99. doi: 10.1136/ard.36.6.491.
- Background: PubMed 1437955Jankowski J, Crombie I, Jankowski R. Behcet's syndrome in Scotland. Postgrad Med J. 1992 Jul;68(801):566-70. doi: 10.1136/pgmj.68.801.566.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hatice N Sen, M.D. principal investigator
National Eye Institute (NEI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Behcet's Disease and Uveitis, run by National Eye Institute (NEI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishing evidence for serum biomarkers associated with BD and establishing demethylation differences between ocular and non-ocular BD participants and controls. (time frame: Ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01109433, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2019.