SLENCT00275899
Role of DcR3 in T Cell Activation in SLE and RA
An observational study of SLE and Rheumatoid Arthritis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SLE, Rheumatoid Arthritis
- How many people
- 450 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2006to Dec 2007
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- SLE, RA
Who cannot join
- nil
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Ping-Ning Hsu, MD, PhD, +886-223123456 ext. 8635, phsu@ha.mc.ntu.edu.tw
Ping-Ning Hsu, MD, PhD
About this study
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.
Read the detailed description
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.
- 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.
- The gene sequencing and single nucleotide polymorphism (SNP) analysis of DcR3 genes.
- The association of clinical manifestation of SLE and RA with genetic polymorphism on DcR3 genes.
- Conditions
- SLE, Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2006 (estimated)
- Study startJan 2006
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SLEStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 450 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ping-Ning Hsu, MD, PhD, Principal investigator, Department of Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00275899
- Sponsor's protocol ID
- 9461701220
- Status last verified
- Dec 2005
- First submitted
- 11 Jan 2006
- Last updated
- 12 Jan 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of DcR3 in T Cell Activation in SLE and RA
- ClinicalTrials.gov ID
- NCT00275899
- Acronym / sponsor ID
- 9461701220
- Conditions
- SLE, Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Dec 2007
- First posted
- 12 Jan 2006 (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.
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.
Detailed description
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.
- 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.
- The gene sequencing and single nucleotide polymorphism (SNP) analysis of DcR3 genes.
- The association of clinical manifestation of SLE and RA with genetic polymorphism on DcR3 genes.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- SLE, RA
Key exclusion criteria (1 listed)
- nil
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2006.
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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.
Ping-Ning Hsu, MD, PhD principal investigator
Department of Immunology
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 SLE and Rheumatoid Arthritis, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 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: status not confirmed, as of the sponsor's last update on 12 Jan 2006. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ping-Ning Hsu, PhD (886-2-23123456 ext. 8635, phsu@ha.mc.ntu.edu.tw), or a site near the patient. 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 12 Jan 2006.