Applications for Methotrexate Optimization in Rheumatoid Arthritis

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Avise PG - Diagnostic test

Other

Eligible patients will receive an Avise PG test

Other names: Measure of methotrexate polyglutamates test

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Cypress Bioscience, Inc.

Industry

Registry information

Acronym: AMORA

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2010
First posted: Dec 23, 2009
Registry last updated: Jun 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed