Observation on the Treg in the Uveitis Patients (OTUP)

This study has been completed.
Sponsor:
Information provided by:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01306474
First received: February 28, 2011
Last updated: March 2, 2011
Last verified: March 2011
  Purpose

AIM: To study the expression of CD4+CD25+ high regulatory T cells in peripheral blood of patients with uveitis and to explore its role in the development of uveitis.


Condition
Uveitis

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Clinical Study on the Regulatory T Cells in the Uveitis Patients Treated by Methotrexate

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Biospecimen Retention:   Samples Without DNA

Experimental:A Drug: prednisone profess to convinced 1-1.5mg/Kg.d Experimental:B Drug: methotrexate profess to convinced 7.5-15mg/w, concoction prednisone profess to convinced 0.5-1mg/Kg.d


Enrollment: 30
Study Start Date: July 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Prednisone
profess to convinced 1-1.5mg/Kg.d
methotrexate to band prednisone
profess to convinced 7.5-15mg/w, concoction prednisone profess to convinced 0.5-1mg/Kg.d

Detailed Description:

Uveitis describes inflammation that exists in the uveal tract, but the disease course has such a variety of manifestations. Uveitis (intraocular inflammatory diseases) includes sight-threatening diseases such as Behcet disease, birdshot retinochoroidopathy, Vogt-Koyanagi-Harada, sympathetic ophthalmia and ocular sarcoidosis, and may be of infectious or autoimmune etiology.

CD4+ CD25+ Tr cells play a key role in the maintenance of peripheral self-tolerance by inhibiting the activation and proliferation of unreactive T cells. In addition to a direct suppressor effect on CD4+CD25+ Tr cells. CD4+CD25+ Tr cells may regulate the immune response through dendritic cell. Like cytotoxic T-lymphocytes and natural killer cells,activated human CD4+CD25+ Tr cells display perforin-dependent cytoxicity against autologous target cell, including activated CD4+ and CD8+ T cells.

Experimental autoimmune uveoretinitis (EAU) is a model of uveitis. Regulatory T cells in the uveitis are currently thought to be the etiologic agent of uveitis because IFN-γ,IL-2(interleukin-2),TNF(Tumor Necrosis Factor alpha) levels are elevated in the retina during uveitis Following stimulation with IL-2 expression was upregulated in PBMC(peripheral blood mononuclear cell) of healthy subjects and patients with scleritis or uveitis. By ELISA, we confirmed that IL-2 induced the secretion of the protein in human PBMC and in mouse CD4+T cells. Experiment found, by an intracellular cytokine analysis assay, that the IFN-γ,IL-2,TNF expressing cells were predominantly CD4+T cells with a memory phenotype. Consistent with our RNA data, the percentage of CD4+T cells was higher in scleritis patients than in healthy subjects.

We analyzed peripheral blood of thirty uveitis patients enrolled in Department of Ophthalmology, Xijing Hospital clinical trials. The demographics of the patients, including age, sex, diagnosis and medications at time of sample collection .

Biospecimen Description:

Experimental: A Drug: prednisone profess to convinced 1-1.5mg/Kg.d Experimental: B Drug: methotrexate profess to convinced 7.5-15mg/w, concoction prednisone profess to convinced 0.5-1mg/Kg.d Methods CD4+CD25+ Tr cells, CTLA-4 and an intracellular cytokine analysis assay that the IFN-γ,IL-2,TNF expressing cells were measured in 30 uveitis patients before and after 1 month,3 months of prednisone and methotrexate.

Cytokine assays. For intracellular cytokine detect, CD4+T cells were cultured as indicated above and restimulated for 5h with 1mg/ml phorbol 12-myristate 13-acetate (PMA) and ionomycin (1mg/ml) in the presence of Golgistop, we added antibodies (IFN-γ,IL-2,TNF). We performed cytokine staining using BD Biosciences and analyzed samples by flow cytometry.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Ages eligible for Study:18 Years to 60 Years. Study Population had two eye attacks in a year.

Criteria

Inclusion Criteria:

  • between 18 to 60 years
  • the first episode

Exclusion Criteria:

  • had other intracranial pathologies (e.g.tumor,infection)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01306474

Locations
China, Shaanxi
Department of Ophthalmology, Xijing Hosptial
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital
Investigators
Study Chair: li cai, MD the ophthalmology department, xijing Hospital
  More Information

No publications provided

Responsible Party: licai/the eye department of xijing hospital, no
ClinicalTrials.gov Identifier: NCT01306474     History of Changes
Other Study ID Numbers: xjyy090706
Study First Received: February 28, 2011
Last Updated: March 2, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Xijing Hospital:
CD4/CD25 Tr cell,TNF,IFN-γ,IL-2

Additional relevant MeSH terms:
Chorioretinitis
Uveitis
Choroid Diseases
Choroiditis
Eye Diseases
Panuveitis
Retinal Diseases
Retinitis
Uveal Diseases
Uveitis, Posterior

ClinicalTrials.gov processed this record on October 23, 2014