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Applications for Methotrexate Optimization in Rheumatoid Arthritis

NCT01038349 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 256

Last updated 2011-06-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Avise PG - Diagnostic test

Eligible patients will receive an Avise PG test

Sponsors & Collaborators

  • Cypress Bioscience, Inc.

    lead INDUSTRY

Principal Investigators

  • R. Michael Gendreau, M.D., Ph.D. · Cypress Bioscience, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2009-12-31
Completion
2010-02-28

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01038349 on ClinicalTrials.gov