Pharmacogenetics of Antifolate Drugs in Autoimmune Diseases in Taiwan

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT00944255
• Lead Sponsor: National Chung Hsing University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2009-07
• Study First Submitted: 2009-07-22
• Study First Submitted QC: 2009-07-22
• Last Update Submitted: 2009-07-22
• Study First Posted: 2009-07-23
• Last Update Posted: 2009-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified