Status:
COMPLETED
Study Of The Safety Of CE 224,545 And Methotrexate In Patients With Rheumatoid Arthritis
Lead Sponsor:
Pfizer
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
End Date :
August 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00446784
Start Date
April 1 2007
End Date
August 1 2007
Last Update
May 23 2011
Active Locations (5)
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1
Pfizer Investigational Site
Miami, Florida, United States, 33169
2
Pfizer Investigational Site
Ocala, Florida, United States, 34471
3
Pfizer Investigational Site
Ocala, Florida, United States, 34474
4
Pfizer Investigational Site
Kalamazoo, Michigan, United States, 49007