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NCT00944320 Clinical Trial

Pharmacogenetics of Antifolate Disease Modifying Anti-Rheumatic Drugs in Rheumatoid Arthritis in Taiwan

Rheumatoid Arthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00944320
Other study ID # C05133
Secondary ID
Status Completed
Phase N/A
First received July 22, 2009
Last updated July 22, 2009
Start date February 2006
Est. completion date February 2007

Study information
Verified date July 2009
Source National Chung Hsing University
Contact n/a
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Observational

Clinical 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 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date February 2007
Est. primary completion date February 2007
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Male/female age >18

- Clinical diagnosis of Rheumatoid Arthritis

Exclusion Criteria:

- 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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
National Chung Hsing University Taichung Veterans General Hospital
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