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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00944320
Recruitment Status : Completed
First Posted : July 23, 2009
Last Update Posted : July 23, 2009
Taichung Veterans General Hospital
Information provided by:
National Chung Hsing University

Brief 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.

Condition or disease
Rheumatoid Arthritis

Study Type : Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Study Start Date : February 2006
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
A cross-sectional study involving 100 patients with RA were enrolled from TCVGH.

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.

Responsible Party: En-Pei Isabel Chiang, Department of Food Science and Biotechnology of National Chung Hsing University Identifier: NCT00944320     History of Changes
Other Study ID Numbers: C05133
First Posted: July 23, 2009    Key Record Dates
Last Update Posted: July 23, 2009
Last Verified: July 2009

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents