Rheumatoid Arthritis Clinical Trial
— AMORAOfficial title:
Applications for Methotrexate Optimization in Rheumatoid Arthritis
Verified date | June 2011 |
Source | Cypress Bioscience, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 256 |
Est. completion date | February 2010 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Cypress Bioscience, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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