Arthritis, RheumatoidPhase 1NCT00440492
Study To Evaluate The Pharmacokinetic Interaction Between PLA-695 And Methotrexate In Adults With Rheumatoid Arthritis
A Phase 1 study testing PLA-695 in people with Arthritis, Rheumatoid, run by Wyeth is now a wholly owned subsidiary of Pfizer at 9 sites in 2 countries.
Trial summary
The purpose of this study is to determine if PLA-695 changes the blood concentrations of methotrexate when administered together. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- PLA-695
- How many people
- Not given
- Where
- 9 sitesin 2 countries
- Study dates
- Dec 2006to Nov 2007
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women of nonchildbearing potential with rheumatoid arthritis (RA), aged 18 to 75 years
- RA disease onset after 16 years of age and has had the disease for at least 6 months
- Must be receiving a stable, well-tolerated oral dose of methotrexate (5 to 25 mg) taken once weekly for at least 3 months
Who cannot join
- Evidence of unstable clinically significant disease
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States6 sites
Study site
Charlotte, North Carolina, 28208
Study site
Columbus, Ohio, 43210
Study site
Lake Success, New York, 11042
Study site
Los Angeles, California, 90048
Study site
Palo Alto, California, 94304
Study site
Rochester, New York, 14642
Canada3 sites
Study site
Mississauga, Ontario, L4W 1N2
Study site
Montreal, Quebec, H3P 3P1
Study site
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: An Open-Label Study To Evaluate The Potential Pharmacokinetic Interaction Between PLA-695 And Methotrexate When Coadministered Orally To Adult Subjects With Rheumatoid Arthritis
The purpose of this study is to determine if PLA-695 changes the blood concentrations of methotrexate when administered together.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- PLA-695
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLA-695Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of PLA-695 on the blood concentrations of methotrexate when administered together.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2007 (estimated)
- Study startDec 2006
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440492
- Sponsor's protocol ID
- 3175A3-104
- Status last verified
- Dec 2007
- First submitted
- 23 Feb 2007
- Last updated
- 13 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study To Evaluate The Potential Pharmacokinetic Interaction Between PLA-695 And Methotrexate When Coadministered Orally To Adult Subjects With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00440492
- Acronym / sponsor ID
- 3175A3-104
- Conditions
- Arthritis, Rheumatoid
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Study completion
- Nov 2007 (actual)
- First posted
- 27 Feb 2007 (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 purpose of this study is to determine if PLA-695 changes the blood concentrations of methotrexate when administered together.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women of nonchildbearing potential with rheumatoid arthritis (RA), aged 18 to 75 years
- RA disease onset after 16 years of age and has had the disease for at least 6 months
- Must be receiving a stable, well-tolerated oral dose of methotrexate (5 to 25 mg) taken once weekly for at least 3 months
Key exclusion criteria (1 listed)
- Evidence of unstable clinically significant disease
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 |
|---|---|---|
| PLA-695 | Drug | – |
Primary outcome
To evaluate the effect of PLA-695 on the blood concentrations of methotrexate when administered together.
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 13 Dec 2007.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PLA-695 in people with Arthritis, Rheumatoid, run by Wyeth is now a wholly owned subsidiary of Pfizer at 9 sites in 2 countries.
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 3 inclusion and 1 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 13 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 evaluate the effect of PLA-695 on the blood concentrations of methotrexate when administered together.. 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 13 Dec 2007.