AMORA: Applications for Methotrexate Optimization in Rheumatoid Arthritis

Sponsor

Cypress Bioscience, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01038349

Collaborator

(none)

256

Enrollment

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Other: Avise PG - Diagnostic test

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 Design

Study Type:

Observational

Actual Enrollment :

256 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Applications for Methotrexate Optimization in Rheumatoid Arthritis

Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Feb 1, 2010

Outcome Measures

Primary Outcome Measures

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. [Outcome is determined following the receipt of Avise PG test result]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cypress Bioscience, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01038349

Other Study ID Numbers:

CYP-D-001

First Posted:

Dec 23, 2009

Last Update Posted:

Jun 2, 2011

Last Verified:

Jun 1, 2011

Additional relevant MeSH terms:

Arthritis

Arthritis, Rheumatoid

Methotrexate

Study Results

No Results Posted as of Jun 2, 2011