Applications for Methotrexate Optimization in Rheumatoid Arthritis (AMORA)
The goal of this study is to enable the study sponsor to assess the impact of a marketed or validated blood test has on physicians' clinical treatment decision making when treating RA patients who have been taking methotrexate.
Ultimately, the blood test will allow treating physicians to modify current methotrexate therapy in partially responding Rheumatoid Arthritis (RA) patients' therapy, on an individualized basis, as a means of improving clinical outcomes.
The study requires a blood sample from RA patients who have been on methotrexate therapy for a minimum of 3 months and are having an inadequate response to therapy. Physicians will then be provided with the results of the test indicating the methotrexate polyglutamate (active metabolites of methotrexate) levels in the patient's red blood cells as a means to help determine whether a patient's exposure to methotrexate has been optimized.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Applications for Methotrexate Optimization in Rheumatoid Arthritis|
- To assess the impact of the Avise PG test on physician's clinical treatment decision making process when assessing RA patients having an inadequate response to current MTX therapy. [ Time Frame: Outcome is determined following the receipt of Avise PG test result ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Study Completion Date:||February 2010|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Other: Avise PG - Diagnostic test
This study is currently enrolling individuals who have an established diagnosis of RA and are receiving methotrexate as part of their therapy. Patients are required to submit a blood sample. There is no cost to volunteers who participate.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01038349
|Study Director:||R. Michael Gendreau, M.D., Ph.D.||Cypress Bioscience, Inc.|