Applications for Methotrexate Optimization in Rheumatoid Arthritis (AMORA)

June 1, 2011 updated by: Cypress Bioscience, Inc.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

256

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary Care and Rheumatology Clinics

Description

Inclusion Criteria:

  • Able to read, understand, and sign the informed consent form
  • Able to read, write, and speak English
  • ≥18 years of age
  • Diagnosed with RA within past 24 months (waiver)
  • Taking oral methotrexate therapy for a minimum of 3 months
  • Considered to have an insufficient response to methotrexate and therefore a candidate for change to therapy, including changing MTX dose or changing route of delivery, or adding or switching DMARDs (including but not limited to biologic DMARDs)

Exclusion Criteria:

  • Prior exposure of the study center, study physician or study patient to the Avise PG laboratory test
  • Patients with known abnormal hepatic and or hematological parameters
  • Use of prednisone >10mg/day (or its equivalent)
  • Rheumatologic diagnosis other than primary RA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Outcome is determined following the receipt of Avise PG test result

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cypress Bioscience, Inc.

Investigators

  • Study Director: R. Michael Gendreau, M.D., Ph.D., Cypress Bioscience, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

December 9, 2009

First Submitted That Met QC Criteria

December 18, 2009

First Posted (Estimate)

December 23, 2009

Study Record Updates

Last Update Posted (Estimate)

June 2, 2011

Last Update Submitted That Met QC Criteria

June 1, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYP-D-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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