A Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will investigate the safety and efficacy of an investigational drug, PF-04171327 on the signs and symptoms of rheumatoid arthritis in patients that require glucocorticoids while on background methotrexate. This study will also look at the response of chemical and biological markers in rheumatoid arthritis patients. Lastly, this study will measure the PK (amount of drug in the blood) of methotrexate while patients may be taking PF-04171327.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Prednisone

Criteria

Inclusion Criteria:

• Patients ≥ 18 years of age, diagnosed with rheumatoid arthritis for a minimum duration of 3 months

• On stable dose of methotrexate for at least 6 weeks prior to screening

• Patient must have minimum disease activity level of ≥ 6 tender/painful joints, ≥ 6 swollen joints and CRP ≥ 0.7 mg/dL

• Not currently receiving steroid medication

Exclusion Criteria:

• Pregnant or nursing women

• Patients that have active infections, TB, HIV and/or Hepatitis B or C

• Patients that have a history of intolerance or significant adverse effects with the use of glucocorticoids