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UveitisOTUPNCT01306474

Observation on the Treg in the Uveitis Patients

An observational study of Uveitis, run by Xijing Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Uveitis
How many people
30 participants
Where
1 siteChina
Study dates
Jul 2009to Aug 2010
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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

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

Who may be able to join

  • between 18 to 60 years
  • the first episode

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site
  • Department of Ophthalmology, Xijing Hosptial

    Xi'an, Shaanxi, 710032

Other trials in China

About this study

Official title: Clinical Study on the Regulatory T Cells in the Uveitis Patients Treated by Methotrexate

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.

Read the 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.

Conditions
Uveitis
Keywords
CD4/CD25 Tr cell,TNF,IFN-γ,IL-2
Medical subject headings
Uveitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01306474
Study groupRoleWhat they receive
Prednisoneprofess to convinced 1-1.5mg/Kg.d
methotrexate to band prednisoneprofess to convinced 7.5-15mg/w, concoction prednisone profess to convinced 0.5-1mg/Kg.d

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2011 (estimated)
  2. Study startJul 2009
  3. Primary completionAug 2010
  4. Study completionAug 2010

Resources

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
Family based
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01306474
Sponsor's protocol ID
xjyy090706
Acronym
OTUP
Status last verified
Mar 2011
First submitted
28 Feb 2011
Last updated
3 Mar 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Uveitis, run by Xijing Hospital at 1 site in China.

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 2 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: finished, as of the sponsor's last update on 3 Mar 2011. 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 China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

Where can I read the original study information?
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 3 Mar 2011.

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