Prediction of Methotrexate Response - A Pilot Study (MRS)

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. 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
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Gordon Lam, Carolinas Healthcare System

Brief Summary:

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
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Methotrexate for rheumatic diseases, 2.5 - 25 mg weekly

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with rheumatic disease being newly treated with methotrexate, recruited from a single rheumatology practice

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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01726959

Contact: Sheri Brosnahan, RN, OCN, CCRC 704-403-4165

United States, North Carolina
Carolinas Medical Center - NorthEast Recruiting
Concord, North Carolina, United States, 28025
Contact: Sheri Brosnahan, RN, OCN, CCRC    704-403-4165   
Principal Investigator: Gordon K Lam, MD         
Sponsors and Collaborators
Carolinas Healthcare System
University of North Carolina, Chapel Hill
Principal Investigator: Gordon K. Lam, MD Carolinas Medical Center - NorthEast Rheumatology

Responsible Party: Gordon Lam, Principle Investigator, Carolinas Healthcare System Identifier: NCT01726959     History of Changes
Other Study ID Numbers: MRS1
First Posted: November 15, 2012    Key Record Dates
Last Update Posted: February 6, 2013
Last Verified: February 2013

Keywords provided by Gordon Lam, Carolinas Healthcare System:

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Rheumatic Diseases
Collagen Diseases
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors