Applications for Methotrexate Optimization in Rheumatoid Arthritis (AMORA)
|ClinicalTrials.gov Identifier: NCT01038349|
Recruitment Status : Completed
First Posted : December 23, 2009
Last Update Posted : June 2, 2011
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.
|Condition or disease||Intervention/treatment|
|Rheumatoid Arthritis||Other: Avise PG - Diagnostic test|
|Study Type :||Observational|
|Actual Enrollment :||256 participants|
|Official Title:||Applications for Methotrexate Optimization in Rheumatoid Arthritis|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||February 2010|
- Other: Avise PG - Diagnostic test
Eligible patients will receive an Avise PG testOther Name: Measure of methotrexate polyglutamates test
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01038349
|Study Director:||R. Michael Gendreau, M.D., Ph.D.||Cypress Bioscience, Inc.|