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Observation on the Treg in the Uveitis Patients (OTUP)

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. Read our disclaimer for details. Identifier: NCT01306474
Recruitment Status : Completed
First Posted : March 1, 2011
Last Update Posted : March 3, 2011
Information provided by:
Xijing Hospital

Brief Summary:
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 or disease

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.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Clinical Study on the Regulatory T Cells in the Uveitis Patients Treated by Methotrexate
Study Start Date : July 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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.

Inclusion Criteria:

  • between 18 to 60 years
  • the first episode

Exclusion Criteria:

  • had other intracranial pathologies (e.g.tumor,infection)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01306474

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China, Shaanxi
Department of Ophthalmology, Xijing Hosptial
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital
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Study Chair: li cai, MD the ophthalmology department, xijing Hospital
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Responsible Party: licai/the eye department of xijing hospital Identifier: NCT01306474    
Other Study ID Numbers: xjyy090706
First Posted: March 1, 2011    Key Record Dates
Last Update Posted: March 3, 2011
Last Verified: March 2011
Keywords provided by Xijing Hospital:
CD4/CD25 Tr cell,TNF,IFN-γ,IL-2
Additional relevant MeSH terms:
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Uveal Diseases
Eye Diseases