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

Pfizer

Status and phase

Completed

Phase 1

Conditions

Arthritis, Rheumatoid

Treatments

Drug: Methotrexate

Drug: CE-224,535

Study type

Interventional

Funder types

Industry

Identifiers

NCT00446784

A6341006

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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