Study Of The Safety Of CE 224,545 And Methotrexate In Patients With Rheumatoid Arthritis

A Phase 1, Double Blind Study Of The Safety And Pharmacokinetics Of Multiple Doses Of CE 224,535 In Subjects With Rheumatoid Arthritis Receiving Methotrexate

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

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)

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