Rheumatoid ArthritisAMORANCT01038349
Applications for Methotrexate Optimization in Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Cypress Bioscience, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Avise PG - Diagnostic test
- How many people
- 256 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Feb 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary Care and Rheumatology Clinics
Who may be able to join
- 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)
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Avise PG - Diagnostic test
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avise PG - Diagnostic testOther
Also called Measure of methotrexate polyglutamates test
Eligible patients will receive an Avise PG test
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Outcome is determined following the receipt of Avise PG test result
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cypress Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- R. Michael Gendreau, M.D., Ph.D., Study director, Cypress Bioscience, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038349
- Sponsor's protocol ID
- CYP-D-001
- Acronym
- AMORA
- Status last verified
- Jun 2011
- First submitted
- 9 Dec 2009
- Last updated
- 2 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applications for Methotrexate Optimization in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01038349
- Acronym / sponsor ID
- AMORA / CYP-D-001
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Cypress Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 23 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care and Rheumatology Clinics
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avise PG - Diagnostic testAlso: Measure of methotrexate polyglutamates testEligible patients will receive an Avise PG test | Other | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R. Michael Gendreau, M.D., Ph.D. study director
Cypress Bioscience, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Cypress Bioscience, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2011.