Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-04171327 · 2 trials · 1 indication
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...
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PF-04171327 is an investigational small molecule developed by Pfizer for the treatment of rheumatoid arthritis. It is described as an experimental glucocorticoid compound and has been studied in Phase 2 clinical trials. It is not an approved medicine and remains in clinical development.
PF-04171327 was studied for the treatment of the signs and symptoms of rheumatoid arthritis. Both of its Phase 2 trials enrolled adults with rheumatoid arthritis, and one trial compared different doses of the compound against prednisone and placebo. It has not been approved for any use.
Pfizer, Inc. develops PF-04171327. The company trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored both Phase 2 trials of the compound in rheumatoid arthritis, which together enrolled 409 participants.
PF-04171327 is in Phase 2 development. Both of its clinical trials were Phase 2 studies in rheumatoid arthritis, and both are now completed. No active trials are ongoing, and the compound is investigational rather than approved.
PF-04171327 has been studied in two completed Phase 2 trials. NCT01393639 compared doses of the compound to prednisone and placebo in 323 participants with rheumatoid arthritis. NCT00938587 evaluated the compound in the signs and symptoms of rheumatoid arthritis in 86 participants. Both were randomized, double-blind, and placebo-controlled.