Rheumatoid ArthritisNCT01285336
The Genetic and the Functional Study of DNA Repair System and the Susceptibility to Rheumatoid Arthritis
A study of Rheumatoid Arthritis, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
This study is valuable for the understanding the role of DNA repair system plays in the progression of rheumatoid arthritis and for the development of new therapeutic modality in the future. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteTaiwan
- Study dates
- Aug 2010to not given
- Phase
- Interventional
- 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
- Participant has sang a consent form.
Who cannot join
- Participant is under 18 years old.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
The Institutional Review Board China Medical University Hospital
Taichung
About this study
Official title: The Genetic and the Functional Study of DNA Repair System and the Susceptibility to Rheumatoid Arthritis.
This study is valuable for the understanding the role of DNA repair system plays in the progression of rheumatoid arthritis and for the development of new therapeutic modality in the future.
Read the detailed description
Rheumatoid arthritis (RA) is a symmetric polyarticular arthritis that primarily affects the small diarthrodial joints of the hands and feet. In addition to inflammation in the synovium, which is the joint lining, the aggressive front of tissue called pannus invades and destroys local articular structures. The synovium is normally a relatively acellular structure with a delicate intimal lining. RA is also a chronic autoimmune disease and can lead to deformities and severe disabilities, due to irreversible damage of tendons, joints, and bones. It is known that RA can be considered as a complex genetic disease and many "disease-risk" genes or "disease-protective" genes can be involved. Numerous studies reported the association of IL-6, IL-8 genes with systemic lupus erythematosus (SLE) and the association of HLA-DR gene polymorphisms with RA. In addition, the chronic inflammatory process of RA is mediated through cytokines network, which leads to induce some destructive enzymes, like matrix metalloprotieases, in the cellular synovial tissue of joints. Although RA is a common arthritis with a prevalence of 1% in Taiwan, the pathogenesis is still incompletely studied, especially in DNA repair relative genes.
In this proposal, we would like to perform the following experiments:
- Study the associations of the polymorphisms of DNA repair relative genes and the susceptibility to RA;
- Study the associations of the copy number variation (CNV) of DNA repair relative genes and the susceptibility to RA;
- Functional assay in DNA repair relative genes and compare it with the copy number variation (CNV), genotype and/or haplotype in RA patients; So far, we have analyzed the association between RA and several SNPs of MUTYH in DNA repair systems. We also analyzed the relationship between the SNPs results and RA using the pathological features. These data are helpful to clarify the susceptibility of RA patients with the genotype and/or haplotype in DNA repair system.
This study is valuable for the understanding the role of DNA repair system plays in the progression of rheumatoid arthritis and for the development of new therapeutic modality in the future.
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis (RA), DNA repair system, polymorphism, susceptibility, copy number variation (CNV)
- Medical subject headings
- Arthritis, Rheumatoid, Disease Susceptibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic
| Study group | Role | What they receive |
|---|---|---|
| The genetic and the functional study | Experimental | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2011 (estimated)
- Study startAug 2010
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 China Medical 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285336
- Sponsor's protocol ID
- DMR98-IRB-309-1
- Other IDs
- NSC99-2314-B-039-005-MY3
- Status last verified
- Jan 2012
- First submitted
- 26 Jan 2011
- Last updated
- 28 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Genetic and the Functional Study of DNA Repair System and the Susceptibility to Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT01285336
- Acronym / sponsor ID
- DMR98-IRB-309-1
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis (RA), DNA repair system, polymorphism, susceptibility, copy number variation (CNV)
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Aug 2010
- First posted
- 28 Jan 2011 (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.
This study is valuable for the understanding the role of DNA repair system plays in the progression of rheumatoid arthritis and for the development of new therapeutic modality in the future.
Detailed description
Rheumatoid arthritis (RA) is a symmetric polyarticular arthritis that primarily affects the small diarthrodial joints of the hands and feet. In addition to inflammation in the synovium, which is the joint lining, the aggressive front of tissue called pannus invades and destroys local articular structures. The synovium is normally a relatively acellular structure with a delicate intimal lining. RA is also a chronic autoimmune disease and can lead to deformities and severe disabilities, due to irreversible damage of tendons, joints, and bones. It is known that RA can be considered as a complex genetic disease and many "disease-risk" genes or "disease-protective" genes can be involved. Numerous studies reported the association of IL-6, IL-8 genes with systemic lupus erythematosus (SLE) and the association of HLA-DR gene polymorphisms with RA. In addition, the chronic inflammatory process of RA is mediated through cytokines network, which leads to induce some destructive enzymes, like matrix metalloprotieases, in the cellular synovial tissue of joints. Although RA is a common arthritis with a prevalence of 1% in Taiwan, the pathogenesis is still incompletely studied, especially in DNA repair relative genes.
In this proposal, we would like to perform the following experiments:
- Study the associations of the polymorphisms of DNA repair relative genes and the susceptibility to RA;
- Study the associations of the copy number variation (CNV) of DNA repair relative genes and the susceptibility to RA;
- Functional assay in DNA repair relative genes and compare it with the copy number variation (CNV), genotype and/or haplotype in RA patients; So far, we have analyzed the association between RA and several SNPs of MUTYH in DNA repair systems. We also analyzed the relationship between the SNPs results and RA using the pathological features. These data are helpful to clarify the susceptibility of RA patients with the genotype and/or haplotype in DNA repair system.
This study is valuable for the understanding the role of DNA repair system plays in the progression of rheumatoid arthritis and for the development of new therapeutic modality in the future.
Study design
- Primary purpose
- Health services research
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The genetic and the functional study | Experimental | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participant has sang a consent form.
Key exclusion criteria (1 listed)
- Participant is under 18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic | The genetic and the functional study |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Rheumatoid Arthritis, run by China Medical 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: finished, as of the sponsor's last update on 28 Jan 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 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?
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 28 Jan 2011.