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

This study has been completed.
Sponsor:
Collaborator:
Taichung Veterans General Hospital
Information provided by:
National Chung Hsing University
ClinicalTrials.gov Identifier:
NCT00944320
First received: July 22, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

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
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Chung Hsing University:

Study Start Date: February 2006
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Sampling Method:   Probability Sample
Study Population

A cross-sectional study involving 100 patients with RA were enrolled from TCVGH.

Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: En-Pei Isabel Chiang, Department of Food Science and Biotechnology of National Chung Hsing University
ClinicalTrials.gov Identifier: NCT00944320     History of Changes
Other Study ID Numbers: C05133
Study First Received: July 22, 2009
Last Updated: July 22, 2009
Health Authority: Taiwan: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013