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
  Purpose

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
Rheumatoid Arthritis
Rheumatic Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Carolinas Healthcare System:

Study Start Date: December 2011
Groups/Cohorts
Methotrexate
Methotrexate for rheumatic diseases, 2.5 - 25 mg weekly

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726959

Contacts
Contact: Sheri Brosnahan, RN, OCN, CCRC 704-403-4165 sheri.brosnahan@carolinashealthcare.org

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

No publications provided

Responsible Party: Gordon Lam, Principle Investigator, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT01726959     History of Changes
Other Study ID Numbers: MRS1
Study First Received: November 12, 2012
Last Updated: February 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Carolinas Healthcare System:
methotrexate

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

ClinicalTrials.gov processed this record on October 23, 2014