A Study To Evaluate The Safety And Pharmacokinetic Profile Of A P38 Inhibitor (PH-797804) In Subjects With Rheumatoid Arthritis Who Are Also Taking Methotrexate
- Registration Number
- NCT00620685
- Lead Sponsor
- Pfizer
- Brief Summary
The hypothesis of this study is that the p38 inhibitor (PH-797804) will be safe and well tolerated in subjects with rheumatoid arthritis who are taking methotrexate and will not effect the blood levels of methotrexate.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
Inclusion Criteria
- Adult with RA for at least 6 months
- Stable weekly dosage of oral methotrexate 12.5- 25 mg/week
Exclusion Criteria
- Severe, progressive and/or uncontrolled other disease
- Chronic or recent serious infection; current infection
- Concomitant use of RA therapy other than methotrexate with some exceptions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Placebo - 2 PH-797804 - 3 PH-797804 -
- Primary Outcome Measures
Name Time Method Adverse events, laboratory data, vital signs, 12-lead ECGs and physical examination findings 6 weeks
- Secondary Outcome Measures
Name Time Method Estimate the effects of multiple doses of PH-797804 on the pharmacokinetic profile of methotrexate in subjects with RA taking a stable dose of MTX 6 weeks
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Duncansville, Pennsylvania, United States