| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01393639 | Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid Arthritis | PHASE2 | COMPLETED | 323 | — | — | Sep 27, 2011 | Jun 9, 2014 | Sep 4, 2024 | 93 | United States, Bulgaria +16 |
| NCT00938587 | A Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis | PHASE2 | COMPLETED | 86 | — | — | Oct 7, 2009 | Jul 29, 2010 | Nov 22, 2023 | 41 | United States, Czechia +11 |
ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
Change from baseline in P1NP at week 8 is presented in this outcome measure.
Change from baseline in uNTx/uCr at week 8 is presented in this outcome measure.
DAS28-4 (CRP) examines progression or improvement of RA. It was assessed from swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, CRP (normal range of CRP is less than (\<) 10 milligram per liter \[mg/L\], decrease in the level of CRP indicates reduction in inflammation) and participant global assessment (PGA) of disease activity (participant global assessment of diseases condition scores ranging from 0 \[very well condition\] to 100 \[very poor condition\], higher scores indicated greater affectation due to disease activity). Total DAS28-4 (CRP) transformed score range: 0 (least severe) to 10 (most severe), higher scores indicate more severe disease activity. DAS28-4 (CRP) scores: less than equal to (\<=) 3.2 implied low disease activity; greater than (\>) 3.2 to 5.1 implied moderate to high disease activity.
| Arm | Type | Description |
|---|---|---|
| PF-04171327 1 mg QD | EXPERIMENTAL | - |
| PF-04171327 5 mg QD | EXPERIMENTAL | - |
| PF-04171327 10 mg QD | EXPERIMENTAL | - |
| PF-04171327 15 mg QD | EXPERIMENTAL | - |
| prednisone 5 mg QD | ACTIVE_COMPARATOR | - |
| prednisone 10 mg QD | ACTIVE_COMPARATOR | - |
| placebo | PLACEBO_COMPARATOR | - |
| PF-04171327 10 mg | EXPERIMENTAL | - |
| PF-04171327 25 mg | EXPERIMENTAL | - |
| Prednisone | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| PF-04171327 | DRUG | 1 mg tablet once daily (QD) for 8 weeks |
| prednisone | DRUG | 5 mg capsule once daily for 8 weeks |
| placebo | OTHER | placebo (tablet or capsule) once daily (QD) for 8 weeks |
| PF-04171327 10 mg | DRUG | PF-04171327 10 mg tablet every day for 14 days |
| Prednisone Placebo | OTHER | Placebo for Prednisone 5 mg tablet every day for 14 days |
| PF-04171327 25 mg | DRUG | PF-04171327 25 mg tablet every day for 14 days |
| Prednisone 5 mg | DRUG | Prednisone 5 mg tablet every day for 14 days |
| Placebo for PF-04171327 | OTHER | Placebo for PF-04171327 every day for 14 days |
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 an...