Overview

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

Status:
Completed
Trial end date:
2007-08-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Treatments:
Methotrexate
Criteria
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