Rheumatoid ArthritisNCT00172666
Decoy Receptor 3 (DcR3) Polymorphisms in Rheumatoid Arthritis (RA) and Systemic Lupus Erythematosus (SLE)
An observational study of Rheumatoid Arthritis and Systemic Lupus Erythematosus, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Although SLE and RA are correlated with genetic predisposing factors such as human leukocyte antigen (HLA) class II, both diseases and other genetic factors might have contributed to the development of dysregulated lymphocyte activation and autoimmunity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Systemic Lupus Erythematosus
- How many people
- 450 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2005to Jul 2006
- 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, or healthy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chung-Yi Hu
Taipei, 100
Chung-Yi Hu, PhD, 886-2-23123456 ext. 6914, cyhu@ha.mc.ntu.edu.tw
Ping-Ning Hsu, 886-2-23123456 ext. 8635, phsu@ha.mc.ntu.edu.tw
About this study
Official title: Investigating Genetic Polymorphism of Decoy Receptor 3 (DcR3) Gene in Rheumatoid Arthritis and Systemic Lupus Erythematosus
Although SLE and RA are correlated with genetic predisposing factors such as human leukocyte antigen (HLA) class II, both diseases and other genetic factors might have contributed to the development of dysregulated lymphocyte activation and autoimmunity.
Decoy receptor 3 (DcR3)/TR6 is a secreted protein belonging to the tumor necrosis factor (TNF) receptor family. It binds to Fas ligand (FasL), LIGHT, and TL1A that are all TNF family members. It was noted that soluble or solid phase DcR3-Fc co-stimulated proliferation, lymphokine production and cytotoxicity of mouse and human T cells upon T-cell receptor (TCR) ligation. Recently, the investigators found that the serum level of soluble DcR3 was higher in SLE patients than in healthy control subjects (unpublished data). Taken together, the investigators propose that in autoimmune diseases, such as RA and SLE, activated T cells secrete more DcR3 than non-autoimmune controls, which may, in turn, costimulate T cells further and cause dysregulated lymphocyte activation. With the aim to establish the possible correlation between DcR3 genetic polymorphisms, DcR3 expressions, and autoimmune phenotypes, the investigators offer this proposal. They plan to investigate the single nucleotide polymorphisms (SNPs) in the DcR3 gene. The genetic polymorphisms on the DcR3/TR6 gene and circulating DcR3 level will be compared between RA, SLE and non-autoimmune control subjects.
Read the detailed description
Abnormal immune responses permit sustained production of pathogenic subsets of autoantibodies such as anti-DNA, and anti-RNP, anti-RBC, anti-platelet. T cell help is critical to development of full-blown disease; CD4+, CD8+, CD4-, CD8- lymphocytes all help autoantibody production in SLE. There are multiple abnormalities that permit hyper-activated self-reactive B and T cells to dominate the immune repertoire. Defects in cell activation, tolerance, apoptosis, idiotypic networks, immune complex clearance and generation of regulatory cells are all accounted for. SLE may involve only one organ system at disease onset or may be multi-systemic. Rheumatoid inflammation reflexes cause persistent stimulation of T cells by synovial-derived antigens that cross-react with determinants introduced during antecedent exposure to foreign antigens or infectious agents.
Decoy receptor 3 (DCR3/TR6) is a soluble, secreted factor that lacks a trans-membrane domain. It belongs to the TNFR family and is capable of binding to TNF family members FasL, LIGHT and TL1A. DcR3/TR6 mRNA is expressed at high levels in lymph nodes, the spleen and activated T cells. DcR3/TR6 binds to FasL and inhibits the Fas-FasL interaction and FasL-mediated apoptosis of lymphocytes and several tumor cell lines. LIGHT is highly expressed on surface of activated T lymphocytes and macrophages, CD8+ tumor-infiltrating lymphocyte, granulocytes and monocytes but not in the thymus and several human tumor cell lines. LIGHT protein triggers apoptosis of several tumor cells expressing both lymphotoxin β receptor (LTβR) and TR2. It was postulated that DcR3/TR6 modulated LIGHT-triggered costimulation via TR2 in T cells. Human PBMCs secrete DcR3/TR6 after PHA or anti-CD3. The leukocyte aggregation in mixed lymphocyte reaction was inhibited by adding soluble form DcR3. On the other hand, it was shown that DcR3/TR6, TR2, LIGHT displayed complexity in their interaction. The DcR3/TR6 expressed in solid phase actually transduced reverse, costimulatory signals into the activated T cells. Soluble DcR3-Fc or solid-phase DcR3-Fc was found to costimulate proliferation, lymphokine production and cytotoxicity of murine and human T cells in the presence of suboptimal TCR ligation. Furthermore, cross linking Th1 and Th2 cells with solid-phase DcR3-Fc along with suboptimal concentration of anti-CD3 enhanced proliferation of both Th1 and Th2 cells, and augmented Th1 but not Th2 cytokine production. These strongly suggest that DcR3/TR6 delivers costimulation through its ligand(s) on T cells, at least part of the costimulation is transduced via LIGHT. Recently, we found that soluble DcR3/TR6 level in circulating plasma in SLE patients was significantly higher than that of non-autoimmune control subjects. Plate-bound form DcR3 enhanced proliferation of T cells under suboptimal anti-CD3 stimulation in both normal and SLE patients. Addition of soluble DcR3-Fc reduced activation-induced cell death in T cells subjected to anti-CD3 re-stimulation (unpublished data). Taken together, it raises the possibility that genetic polymorphism in DcR3/TR6 locus might influence the expression level or function of DcR3, which in turn is implicated in dysregulated lymphocyte activation and autoimmunity. With the aim to establish the possible correlation between DcR3 genetic polymorphism, DcR3 expression, and autoimmune phenotypes, we give this proposal. We plan to investigate the single nucleotide polymorphisms (SNPs) in DcR3 gene. The genetic polymorphisms on DcR3/TR6 gene and circulating DcR3 level will be compared between RA, SLE and non-autoimmune control subjects.
The specific aims of this project are the following:
- To study the allelic distribution of DcR3 genetic polymorphisms among the population in Taiwan.
- To investigate if there is any DcR3 allele correlate to serum level of DcR3.
- To investigate if the genetic polymorphism on DcR3 gene be associated with autoimmune diseases RA and SLE.
- Conditions
- Rheumatoid Arthritis, Systemic Lupus Erythematosus
- Keywords
- SLE, healthy subjects
- Medical subject headings
- Arthritis, Rheumatoid, Lupus Erythematosus, Systemic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startAug 2005
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Chung-Yi Hu, PhD, Principal investigator, Department of Clinical Laboratory Sciences and Medical Biotechnology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00172666
- Sponsor's protocol ID
- 9361701218
- Other IDs
- NSC 94-2320-B-002-085
- Status last verified
- Dec 2004
- First submitted
- 12 Sep 2005
- Last updated
- 30 Mar 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Genetic Polymorphism of Decoy Receptor 3 (DcR3) Gene in Rheumatoid Arthritis and Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT00172666
- Acronym / sponsor ID
- 9361701218
- Conditions
- Rheumatoid Arthritis, Systemic Lupus Erythematosus
- Keywords
- SLE, healthy subjects
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2005
- Study completion
- Jul 2006
- First posted
- 15 Sep 2005 (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.
Although SLE and RA are correlated with genetic predisposing factors such as human leukocyte antigen (HLA) class II, both diseases and other genetic factors might have contributed to the development of dysregulated lymphocyte activation and autoimmunity.
Decoy receptor 3 (DcR3)/TR6 is a secreted protein belonging to the tumor necrosis factor (TNF) receptor family. It binds to Fas ligand (FasL), LIGHT, and TL1A that are all TNF family members. It was noted that soluble or solid phase DcR3-Fc co-stimulated proliferation, lymphokine production and cytotoxicity of mouse and human T cells upon T-cell receptor (TCR) ligation. Recently, the investigators found that the serum level of soluble DcR3 was higher in SLE patients than in healthy control subjects (unpublished data). Taken together, the investigators propose that in autoimmune diseases, such as RA and SLE, activated T cells secrete more DcR3 than non-autoimmune controls, which may, in turn, costimulate T cells further and cause dysregulated lymphocyte activation. With the aim to establish the possible correlation between DcR3 genetic polymorphisms, DcR3 expressions, and autoimmune phenotypes, the investigators offer this proposal. They plan to investigate the single nucleotide polymorphisms (SNPs) in the DcR3 gene. The genetic polymorphisms on the DcR3/TR6 gene and circulating DcR3 level will be compared between RA, SLE and non-autoimmune control subjects.
Detailed description
Abnormal immune responses permit sustained production of pathogenic subsets of autoantibodies such as anti-DNA, and anti-RNP, anti-RBC, anti-platelet. T cell help is critical to development of full-blown disease; CD4+, CD8+, CD4-, CD8- lymphocytes all help autoantibody production in SLE. There are multiple abnormalities that permit hyper-activated self-reactive B and T cells to dominate the immune repertoire. Defects in cell activation, tolerance, apoptosis, idiotypic networks, immune complex clearance and generation of regulatory cells are all accounted for. SLE may involve only one organ system at disease onset or may be multi-systemic. Rheumatoid inflammation reflexes cause persistent stimulation of T cells by synovial-derived antigens that cross-react with determinants introduced during antecedent exposure to foreign antigens or infectious agents.
Decoy receptor 3 (DCR3/TR6) is a soluble, secreted factor that lacks a trans-membrane domain. It belongs to the TNFR family and is capable of binding to TNF family members FasL, LIGHT and TL1A. DcR3/TR6 mRNA is expressed at high levels in lymph nodes, the spleen and activated T cells. DcR3/TR6 binds to FasL and inhibits the Fas-FasL interaction and FasL-mediated apoptosis of lymphocytes and several tumor cell lines. LIGHT is highly expressed on surface of activated T lymphocytes and macrophages, CD8+ tumor-infiltrating lymphocyte, granulocytes and monocytes but not in the thymus and several human tumor cell lines. LIGHT protein triggers apoptosis of several tumor cells expressing both lymphotoxin β receptor (LTβR) and TR2. It was postulated that DcR3/TR6 modulated LIGHT-triggered costimulation via TR2 in T cells. Human PBMCs secrete DcR3/TR6 after PHA or anti-CD3. The leukocyte aggregation in mixed lymphocyte reaction was inhibited by adding soluble form DcR3. On the other hand, it was shown that DcR3/TR6, TR2, LIGHT displayed complexity in their interaction. The DcR3/TR6 expressed in solid phase actually transduced reverse, costimulatory signals into the activated T cells. Soluble DcR3-Fc or solid-phase DcR3-Fc was found to costimulate proliferation, lymphokine production and cytotoxicity of murine and human T cells in the presence of suboptimal TCR ligation. Furthermore, cross linking Th1 and Th2 cells with solid-phase DcR3-Fc along with suboptimal concentration of anti-CD3 enhanced proliferation of both Th1 and Th2 cells, and augmented Th1 but not Th2 cytokine production. These strongly suggest that DcR3/TR6 delivers costimulation through its ligand(s) on T cells, at least part of the costimulation is transduced via LIGHT. Recently, we found that soluble DcR3/TR6 level in circulating plasma in SLE patients was significantly higher than that of non-autoimmune control subjects. Plate-bound form DcR3 enhanced proliferation of T cells under suboptimal anti-CD3 stimulation in both normal and SLE patients. Addition of soluble DcR3-Fc reduced activation-induced cell death in T cells subjected to anti-CD3 re-stimulation (unpublished data). Taken together, it raises the possibility that genetic polymorphism in DcR3/TR6 locus might influence the expression level or function of DcR3, which in turn is implicated in dysregulated lymphocyte activation and autoimmunity. With the aim to establish the possible correlation between DcR3 genetic polymorphism, DcR3 expression, and autoimmune phenotypes, we give this proposal. We plan to investigate the single nucleotide polymorphisms (SNPs) in DcR3 gene. The genetic polymorphisms on DcR3/TR6 gene and circulating DcR3 level will be compared between RA, SLE and non-autoimmune control subjects.
The specific aims of this project are the following:
- To study the allelic distribution of DcR3 genetic polymorphisms among the population in Taiwan.
- To investigate if there is any DcR3 allele correlate to serum level of DcR3.
- To investigate if the genetic polymorphism on DcR3 gene be associated with autoimmune diseases RA and SLE.
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, or healthy
Key exclusion criteria (0 listed)
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 30 Mar 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.
Chung-Yi Hu, PhD principal investigator
Department of Clinical Laboratory Sciences and Medical Biotechnology
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 Rheumatoid Arthritis and Systemic Lupus Erythematosus, 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 0 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 30 Mar 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 Chung-Yi Hu, PhD (886-2-23123456 ext. 6914, cyhu@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 30 Mar 2006.