Prediction of Methotrexate Response - A Pilot Study (MRS)
|ClinicalTrials.gov Identifier: NCT01726959|
Recruitment Status : Unknown
Verified February 2013 by Gordon Lam, Carolinas Healthcare System.
Recruitment status was: Recruiting
First Posted : November 15, 2012
Last Update Posted : February 6, 2013
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.
|Condition or disease|
|Rheumatoid Arthritis Rheumatic Diseases|
|Study Type :||Observational|
|Study Start Date :||December 2011|
Methotrexate for rheumatic diseases, 2.5 - 25 mg weekly
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01726959
|Contact: Sheri Brosnahan, RN, OCN, CCRCfirstname.lastname@example.org|
|United States, North Carolina|
|Carolinas Medical Center - NorthEast||Recruiting|
|Concord, North Carolina, United States, 28025|
|Contact: Sheri Brosnahan, RN, OCN, CCRC 704-403-4165 email@example.com|
|Principal Investigator: Gordon K Lam, MD|
|Principal Investigator:||Gordon K. Lam, MD||Carolinas Medical Center - NorthEast Rheumatology|