Prediction of Methotrexate Response - A Pilot Study (MRS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Carolinas Healthcare System
Sponsor:
Collaborator:
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Gordon Lam, Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT01726959
First received: November 12, 2012
Last updated: February 5, 2013
Last verified: February 2013

November 12, 2012
February 5, 2013
December 2011
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Complete list of historical versions of study NCT01726959 on ClinicalTrials.gov Archive Site
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Prediction of Methotrexate Response - A Pilot Study
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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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patient with rheumatic disease being newly treated with methotrexate, recruited from a single rheumatology practice

  • Rheumatoid Arthritis
  • Rheumatic Diseases
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Methotrexate
Methotrexate for rheumatic diseases, 2.5 - 25 mg weekly
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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Inclusion Criteria:

  • All adult patients (i.e. >18 years of age) who are enrolled at NorthEast Rheumatology at the Carolinas Medical Center - NorthEast who will be initiating MTX as standard treatment for their particular rheumatic disease, which may include (but not be limited to) conditions such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, inflammatory-bowel disease related arthropathies, lupus (systemic lupus erythematosus, cutaneous lupus erythematosus), Sjogren's syndrome, Behcet's disease, systemic sclerosis, and vasculitides.
  • No prior enrollment into this study
  • Enrollment and initial blood sample collection prior to first MTX administration
  • Written informed consent

Exclusion Criteria:

  • NONE
Both
18 Years and older
No
Contact: Sheri Brosnahan, RN, OCN, CCRC 704-403-4165 sheri.brosnahan@carolinashealthcare.org
United States
 
NCT01726959
MRS1
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Gordon Lam, Carolinas Healthcare System
Carolinas Healthcare System
University of North Carolina, Chapel Hill
Principal Investigator: Gordon K. Lam, MD Carolinas Medical Center - NorthEast Rheumatology
Carolinas Healthcare System
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP