An observational study in Rheumatoid Arthritis and Rheumatic Diseases, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-02.
Sponsored by Wake Forest University Health Sciences · Observational
The objective of this study is to identify genetic predictors of individual methotrexate (MTX) response in patients with rheumatic diseases by determining genetic and metabolomic factors related to nutrient metabolism and drug transport.
The development of better genetic predictors of individual MTX treatment response would provide invaluable prognostic information prior to initiating treatment, which would allow more appropriate choice of therapy, decreased adverse events, and more efficient dose-escalation of the drug, with ultimate benefits of improved effectiveness and tolerability rates in patients being treated with MTX for autoimmune diseases.
Despite being the gold-standard therapy for rheumatoid arthritis and other types of chronic autoimmune diseases since 1951, MTX's efficacy and safety profile limit its use: MTX is discontinued in greater than 50% of patients secondary to inefficacy or poor tolerability. Upon initial treatment, discontinuation rates approach 12% because of drug toxicity, despite prophylactic measures such as the co-administration of folic acid. The causes of primary failure, secondary failure, and adverse events of MTX may be related to genetic variation of dihydrofolate reductase (DHFR) and other genes involved in folate metabolism, one-carbon transfer, and drug transport. The purpose of this study is to identify genetic variations involved in methotrexate response so that we may better understand the pharmacodynamics of MTX metabolism in patients with rheumatic diseases.
377 studies on the registry are indexed under Rheumatic Diseases; 79 are open to participants now.
This study's enrollment of 36 is below the median of 245 across 157 observational studies indexed under Rheumatic Diseases.
Browse Rheumatic Diseases studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patient with rheumatic disease being newly treated with methotrexate, recruited from a single rheumatology practice
Exclusion Criteria:
Methotrexate for rheumatic diseases, 2.5 - 25 mg weekly
lymphocyte proliferation
Time frame: 9 days in culture
dihydrofolate reductase expression
Time frame: 9 days in culture
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences