Applications for Methotrexate Optimization in Rheumatoid Arthritis

NCT01038349 | Completed

• 1 other identifier: CYP-D-001
• Study Type: observational
• Target: 256
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (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.

  Outcome is determined following the receipt of Avise PG test result

Interventions

Avise PG - Diagnostic test OTHER

Eligible patients will receive an Avise PG test

Also known as: Measure of methotrexate polyglutamates test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary Care and Rheumatology Clinics

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cypress Bioscience, Inc.: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

• R. Michael Gendreau, M.D., Ph.D.

  Cypress Bioscience, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 9, 2009
• First Posted: December 23, 2009
• Study Start: June 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: February 1, 2010
• Last Updated: June 2, 2011

Record last verified: 2011-06