Study To Evaluate The Pharmacokinetic Interaction Between PLA-695 And Methotrexate In Adults With Rheumatoid Arthritis
An Open-Label Study To Evaluate The Potential Pharmacokinetic Interaction Between PLA-695 And Methotrexate When Coadministered Orally To Adult Subjects With Rheumatoid Arthritis
1 other identifier
interventional
N/A
2 countries
9
Brief Summary
The purpose of this study is to determine if PLA-695 changes the blood concentrations of methotrexate when administered together.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2006
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 23, 2007
CompletedFirst Posted
Study publicly available on registry
February 27, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedDecember 13, 2007
December 1, 2007
February 23, 2007
December 11, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
To evaluate the effect of PLA-695 on the blood concentrations of methotrexate when administered together.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Evidence of unstable clinically significant disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Unknown Facility
Los Angeles, California, 90048, United States
Unknown Facility
Palo Alto, California, 94304, United States
Unknown Facility
Lake Success, New York, 11042, United States
Unknown Facility
Rochester, New York, 14642, United States
Unknown Facility
Charlotte, North Carolina, 28208, United States
Unknown Facility
Columbus, Ohio, 43210, United States
Unknown Facility
Vancouver, British Columbia, V5Z 1M9, Canada
Unknown Facility
Mississauga, Ontario, L4W 1N2, Canada
Unknown Facility
Montreal, Quebec, H3P 3P1, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 23, 2007
First Posted
February 27, 2007
Study Start
December 1, 2006
Study Completion
November 1, 2007
Last Updated
December 13, 2007
Record last verified: 2007-12