A Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis
Status: | Completed |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/6/2018 |
Start Date: | October 2009 |
End Date: | July 2010 |
A Phase 2a, Randomized, Double-Blind, Active And Placebo-Controlled Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis
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.
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.
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
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