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| Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid Arthritis |
| 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. |
| Not Provided |
| Interventional |
| Phase 2 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment |
| Rheumatoid Arthritis |
- Drug: PF-04171327
1 mg tablet once daily (QD) for 8 weeks - Drug: PF-04171327
5 mg tablet once daily (QD) for 8 weeks - Drug: PF-04171327
10 mg tablet once daily (QD) for 8 weeks - Drug: PF-04171327
15 mg tablet once daily (QD) for 8 weeks - Drug: prednisone
5 mg capsule once daily for 8 weeks - Other: prednisone
10 mg capsule once daily for 8 weeks - Other: placebo
placebo (tablet or capsule) once daily (QD) for 8 weeks
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- Experimental: PF-04171327 1 mg QD
Intervention: Drug: PF-04171327 - Experimental: PF-04171327 5 mg QD
Intervention: Drug: PF-04171327 - Experimental: PF-04171327 10 mg QD
Intervention: Drug: PF-04171327 - Experimental: PF-04171327 15 mg QD
Intervention: Drug: PF-04171327 - Active Comparator: prednisone 5 mg QD
Intervention: Drug: prednisone - Active Comparator: prednisone 10 mg QD
Intervention: Other: prednisone - Placebo Comparator: placebo
Intervention: Other: placebo
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| Buttgereit F, Strand V, Lee EB, Simon-Campos A, McCabe D, Genet A, Tammara B, Rojo R, Hey-Hadavi J. Fosdagrocorat (PF-04171327) versus prednisone or placebo in rheumatoid arthritis: a randomised, double-blind, multicentre, phase IIb study. RMD Open. 2019 Apr 16;5(1):e000889. doi: 10.1136/rmdopen-2018-000889. eCollection 2019. |
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| Completed |
| 323 |
| 315 |
| June 2014 |
| June 2014 (Final data collection date for primary outcome measure) |
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.
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| Sexes Eligible for Study: | All |
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| 18 Years and older (Adult, Older Adult) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Bulgaria, Colombia, Czechia, Germany, Hungary, India, Korea, Republic of, Malaysia, Mexico, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Ukraine, United States |
| Canada, Czech Republic |
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| NCT01393639 |
A9391010
2010-023782-22 ( EudraCT Number ) |
| Yes |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
|
| Pfizer |
| December 2018 |
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