Rheumatoid ArthritisNCT00944320
Pharmacogenetics of Antifolate Disease Modifying Anti-Rheumatic Drugs in Rheumatoid Arthritis in Taiwan
An observational study of Rheumatoid Arthritis, run by National Chung Hsing University.
Trial summary
Polymorphisms occur in several genes encoding key enzymes in the folate pathway may affect drug metabolism in patients with rheumatoid arthritis. Whether these genetic variations contribute to differential responses to antifolate drug in patients with rheumatoid arthritis (RA) remains to be investigated in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Feb 2006to Feb 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
- Adult, Older adult
Study population: A cross-sectional study involving 100 patients with RA were enrolled from TCVGH.
Who may be able to join
- Male/female age >18
- Clinical diagnosis of Rheumatoid Arthritis
Who cannot join
- Must not be pregnant/breastfeeding
- Other conditions may lead to exclusion from the trial (e.g. Diabetes mellitis, malignant melanoma, cardiac conduction disorders, hepatic/renal insufficiency.
About this study
Polymorphisms occur in several genes encoding key enzymes in the folate pathway may affect drug metabolism in patients with rheumatoid arthritis. Whether these genetic variations contribute to differential responses to antifolate drug in patients with rheumatoid arthritis (RA) remains to be investigated in the Taiwanese population.
Objective. The goal of the present study is to investigate the interactions between genetic variations in folate genes and the efficacy/side effects of anti-folate disease-modifying antirheumatic drug in Taiwan.
DESIGN. A cross-sectional study involving 100 patients with RA were enrolled from TCVGH. Genotypes in methylenetetrahydrofolate reductase (MTHFR677C>T), tandem repeat polymorphism in thymidylate synthase enhancer region (TSER) and folylpoly-gamma-glutamate synthetase (FPGS1901T>C) were determined by RFLP or pyrosequencing.
- Conditions
- 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 posted23 Jul 2009 (estimated)
- Study startFeb 2006
- Primary completionFeb 2007
- Study completionFeb 2007
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.
- 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
- Cross-sectional
Sponsor and investigators
- Lead sponsor
- National Chung Hsing University
- Sponsor type
- University, hospital or other
- Collaborators
- Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944320
- Sponsor's protocol ID
- C05133
- Status last verified
- Jul 2009
- First submitted
- 22 Jul 2009
- Last updated
- 23 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenetics of Antifolate Disease Modifying Anti-Rheumatic Drugs in Rheumatoid Arthritis in Taiwan
- ClinicalTrials.gov ID
- NCT00944320
- Acronym / sponsor ID
- C05133
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Chung Hsing UniversityUniversity, hospital or other
- Collaborators
- Taichung Veterans General Hospital
- Study start
- Feb 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 23 Jul 2009 (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.
Polymorphisms occur in several genes encoding key enzymes in the folate pathway may affect drug metabolism in patients with rheumatoid arthritis. Whether these genetic variations contribute to differential responses to antifolate drug in patients with rheumatoid arthritis (RA) remains to be investigated in the Taiwanese population.
Objective. The goal of the present study is to investigate the interactions between genetic variations in folate genes and the efficacy/side effects of anti-folate disease-modifying antirheumatic drug in Taiwan.
DESIGN. A cross-sectional study involving 100 patients with RA were enrolled from TCVGH. Genotypes in methylenetetrahydrofolate reductase (MTHFR677C>T), tandem repeat polymorphism in thymidylate synthase enhancer region (TSER) and folylpoly-gamma-glutamate synthetase (FPGS1901T>C) were determined by RFLP or pyrosequencing.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A cross-sectional study involving 100 patients with RA were enrolled from TCVGH.
Key inclusion criteria (2 listed)
- Male/female age >18
- Clinical diagnosis of Rheumatoid Arthritis
Key exclusion criteria (2 listed)
- Must not be pregnant/breastfeeding
- Other conditions may lead to exclusion from the trial (e.g. Diabetes mellitis, malignant melanoma, cardiac conduction disorders, hepatic/renal insufficiency.
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
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 23 Jul 2009.
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by National Chung Hsing University.
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 2 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 23 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
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 23 Jul 2009.