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Applications for Methotrexate Optimization in Rheumatoid Arthritis (AMORA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01038349
Recruitment Status : Completed
First Posted : December 23, 2009
Last Update Posted : June 2, 2011
Sponsor:
Information provided by:

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
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 : June 2009
Primary Completion Date : December 2009
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Other: Avise PG - Diagnostic test
    Eligible patients will receive an Avise PG test
    Other Name: Measure of methotrexate polyglutamates test

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Care and Rheumatology Clinics
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01038349


Sponsors and Collaborators
Cypress Bioscience, Inc.
Investigators
Study Director: R. Michael Gendreau, M.D., Ph.D. Cypress Bioscience, Inc.
More Information

Responsible Party: R. Michael Gendreau, M.D., Ph.D, Vice President, Chief Medical Officer, Cypress Bioscience, Inc
ClinicalTrials.gov Identifier: NCT01038349     History of Changes
Other Study ID Numbers: CYP-D-001
First Posted: December 23, 2009    Key Record Dates
Last Update Posted: June 2, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors