Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid Arthritis
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Rheumatoid Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/16/2018 |
| Start Date: | September 2011 |
| End Date: | June 2014 |
A Phase 2, Randomized, Double Blind Assessment Of Efficacy And Safety Of Pf 04171327(1, 5, 10, 15 Mg Dose, Daily) Compared To 5 Mg And 10 Mg Prednisone Daily And Placebo Daily In Subjects With Rheumatoid Arthritis Over An 8 Week Period Followed By A 4 Week Period Of Tapering Of Study Drug.
The purpose of this study is to compare the safety and efficacy of multiple doses of
PF-04171327, an experimental glucocorticoid drug, to prednisone at 5 mg or 10 mg and placebo
in the treatment of rheumatoid arthritis. All subjects will also be receiving background
treatment of methotrexate for their rheumatoid arthritis. Study medication will be given for
eight weeks followed by a 4 week period during which the dose of study medication will be
gradually reduced. The efficacy of the study medications will be determined by assessing
severity of the rheumatoid arthritis during the study and safety will be determined by
adverse event reporting, laboratory tests and biomarker analysis.
PF-04171327, an experimental glucocorticoid drug, to prednisone at 5 mg or 10 mg and placebo
in the treatment of rheumatoid arthritis. All subjects will also be receiving background
treatment of methotrexate for their rheumatoid arthritis. Study medication will be given for
eight weeks followed by a 4 week period during which the dose of study medication will be
gradually reduced. The efficacy of the study medications will be determined by assessing
severity of the rheumatoid arthritis during the study and safety will be determined by
adverse event reporting, laboratory tests and biomarker analysis.
Inclusion Criteria:
- Subjects must have documented rheumatoid arthritis with a duration of at least 3
months as determined by the investigator using standardly accepted criteria, must have
been receiving methotrexate for at least 3 months to treat their rheumatoid arthritis,
and must be free of any signs or symptoms of infection.
Exclusion Criteria:
- Subjects cannot enter the study if they have recently received treatment with certain
medications which might interfere with study medications;
- subjects cannot enter if they have abnormalities in certain blood tests, history of
cancer, recent bone fracture or other significant conditions.
We found this trial at
15
sites
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