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Pharmacogenetics of Antifolate Drugs in Autoimmune Diseases in Taiwan

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00944255
First Posted: July 23, 2009
Last Update Posted: July 23, 2009
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.
Information provided by:
National Chung Hsing University
  Purpose

BACKGROUND. 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 anti-rheumatic drug in Taiwan.

DESIGN. A cross-sectional study involving patients with RA were enrolled from TCVGH. Disease activity, drug efficacy and associated side-effects were assessed.

Genotypes in folylpoly-gamma-glutamate synthetase and reduced folate carrier 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:


Further study details as provided by National Chung Hsing University:

Study Start Date: February 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
RA with drug
RA without drug

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
A cross-sectional study involving 150 patients with RA were enrolled from TCVGH.
Criteria

Inclusion Criteria:

  • Male/female age >18
  • RA diagnosed

Exclusion Criteria:

  • Must not be pregnant/breastfeeding
  • Other conditions may lead to exclusion from the trial (e.g. Diabetes mellitus, malignant melanoma, cardiac conduction disorders, hepatic/renal insufficiency.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

ClinicalTrials.gov Identifier: NCT00944255     History of Changes
Other Study ID Numbers: C06289
First Submitted: July 22, 2009
First Posted: July 23, 2009
Last Update Posted: July 23, 2009
Last Verified: July 2009

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