Role of DcR3 in T Cell Activation in SLE and RA
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|ClinicalTrials.gov Identifier: NCT00275899|
Recruitment Status : Unknown
Verified December 2005 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : January 12, 2006
Last Update Posted : January 12, 2006
|First Submitted Date||January 11, 2006|
|First Posted Date||January 12, 2006|
|Last Update Posted Date||January 12, 2006|
|Study Start Date||January 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures||Not Provided|
|Original Primary Outcome Measures||Not Provided|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Role of DcR3 in T Cell Activation in SLE and RA|
|Official Title||Role of DcR3 in T Cell Activation in SLE and RA|
|Brief Summary||Decoy receptor 3 (DcR3), a new member of tumor necrosis factor receptor (TNFR) superfamily, is a decoy receptor for FasL and could inhibit FasL-induced apoptosis, has recently been shown to induce costimulation of T cells. Systemic lupus erythematosus (SLE) is an autoimmune disease with pathogenic autoantibodies and immune complexes results from abnormal immune responses including T and B lymphocyte hyperactivity, and formation of pathogenic subsets of autoantibodies. Rhematoid arthritis (RA) is a multi-systemic autoimmune disease characterized by persistent inflammatory synovitis. Activated T lymphocytes infiltration to synovium is strongly correlated with the symptoms. DcR3 mRNA is expressed in peripheral-blood T cells and is up-regulated after antigenic stimulation. The DcR3 gene has been demonstrated to be overexpressed in patients with sclerosis or SLE; however, role of DcR3 in SLE and RA as well as the effects of DcR3 on T cell immune response is still not clear. This study is to investigate role of DcR3-induced T cell activation in SLE and RA. The genetic polymorphisms of DcR3 in association with SLE and RA will be studied to elucidate the genetic factors associated with development of SLE and RA. For further explore the possible molecular mechanisms of elevated DcR3 in association with SLE, we attempt to study whether DcR3 could induce T cell activation via costimualtion and/or inhibit the activation induced cell death (AICD) of activated T cells in SLE and RA. This study will provide a new direction of therapy in reverse T cell hyper-reactivity in SLE and RA.|
Specific Aim 1. Study DcR3-induced T cell activation in SLE and RA. A. Patients and controls Patients with SLE and RA in Department of Internal Medicine, National Taiwan University Hospital will be studied. All patient meet the criteria of the American College of Rheumatologists for diagnosis of SLE and RA. As controls, 20 healthy age- and gender-matched volunteers will be used. All the studies including samples involving human is in accordance with institutional guidelines.
B. Detection of serum DcR3 protein in SLE and RA patients C. T cell proliferation assay
Specific Aim 2. Study effects of DcR3 on activation-induced cell death (AICD) in SLE and RA In order to understand whether DcR3 could reduce the AICD in activated T cells in SLE and RA patients, the T cells from these patients will be assayed their AICD in the presence and absence of soluble DcR3-Fc.
Specific Aim 3. To investigate the association of clinical manifestation of SLE and RA with genetic polymorphism on DcR3 genes.
A. The gene sequencing and single nucleotide polymorphism (SNP) analysis of DcR3 genes.
B. The association of clinical manifestation of SLE and RA with genetic polymorphism on DcR3 genes.
|Study Design||Observational Model: Case Control
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Retrospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status||Unknown status|
|Original Enrollment||Same as current|
|Study Completion Date||December 2007|
|Primary Completion Date||Not Provided|
|Ages||18 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||Taiwan|
|Removed Location Countries|
|Other Study ID Numbers||9461701220|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor||National Taiwan University Hospital|
|PRS Account||National Taiwan University Hospital|
|Verification Date||December 2005|