Study Of The Safety Of CE 224,545 And Methotrexate In Patients With Rheumatoid Arthritis
Phase 1
Completed
- Conditions
- Arthritis, Rheumatoid
- Registration Number
- NCT00446784
- Lead Sponsor
- Pfizer
- Brief Summary
CE 224,535 is being developed for the treatment of rheumatoid arthritis. The purpose of this study is to evaluate the safety and tolerability of CE 224,535 after 4 weeks of treatment in subjects with rheumatoid arthritis already receiving methotrexate
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Adults patients with rheumatoid arthritis
- Patients who have received stable weekly doses of oral methotrexate (5 to 25 mg/week administered as a single dose) for a minimum of 28 days (4 weeks/4 doses)
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Exclusion Criteria
- History of chronic infectious disease such as genitourinary, pulmonary or sinus infections.
- Any current or known malignancy or history of malignancy within the previous 5 years
- Pregnant or lactating women; women of child-bearing potential who are unwilling to unable to use an acceptable method of birth control during the study
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence and severity of adverse events throughout the study
- Secondary Outcome Measures
Name Time Method Pharmacokinetics of CE 224,535 on Days 7 and 8 Pharmacokinetics of Methotrexate on Days 1 and 8
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Ducansville, Pennsylvania, United States