Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-04171327 · 6 trials · 3 indications
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 | - |
| Single dose | EXPERIMENTAL | - |
| Multiple dose | EXPERIMENTAL | - |
| (Part 1) 25 mg PF-04171327 predosed at -8 hours prior to OGTT | EXPERIMENTAL | - |
| (Part 1) 25 mg PF-04171327 predosed at -12 hours prior to OGTT | EXPERIMENTAL | - |
| (Part 1) 5 mg Prednisone | ACTIVE_COMPARATOR | 5 mg prednisone tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT) |
| (Part 2) 3 mg PF-04171327 | EXPERIMENTAL | - |
| (Part 2) 10 mg PF-04171327 | EXPERIMENTAL | - |
| (Part 2) 5 mg Prednisone | ACTIVE_COMPARATOR | - |
| (Part 2) 20 mg Prednisone | ACTIVE_COMPARATOR | - |
| PF-04171327 and Midazolam | OTHER | - |
| PF-04173127 | EXPERIMENTAL | - |
| Prednisolone | ACTIVE_COMPARATOR | - |
| Solution Placebo | SHAM_COMPARATOR | - |
| PF-04171327 Tablet | EXPERIMENTAL | - |
| 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 |
| Midazolam 2 mg | DRUG | Midazolam oral syrup 2mg dose administered once on Day 1 and once on Day 15 |
| Prednisolone | DRUG | Oral doses of prednisolone (5, 10, and 20 mg) will be administered to the first three cohorts. The fourth cohort will receive between 1 and 20 mg to be determined after the third cohort completes dosing. If an additional cohort is required, the dose selected will not exceed 40 mg. Prednisolone tablets will be administered once daily for 14 days |
| Placebo Solution | DRUG | Placebo solution will be administered to those volunteers who are randomized to the placebo or prednisolone arms. This will be administered orally each day for 14 days. |
| PF-04171327 Tablet | DRUG | A single 10 mg dose of PF-04171327 tablet formulation will be administered orally to volunteers in Part 2 of this study. |
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 being developed by Pfizer for rheumatoid arthritis. It has been studied in healthy volunteers to evaluate its safety, tolerability, and pharmacokinetics. The drug is in Phase 1 clinical development and is not approved for any indication.
PF-04171327 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical trials.
PF-04171327 is in Phase 1 clinical development. It has completed two Phase 1 trials in healthy volunteers, with a total enrollment of 409 participants across all studies. The drug is investigational and has not been approved by regulatory authorities.
PF-04171327 has been studied in four Phase 1 clinical trials: NCT00812825, NCT00987038, NCT01199900, and NCT01362673. These trials evaluated multiple-dose escalation, drug interactions with midazolam, effects on carbohydrate metabolism, and pharmacokinetics in Japanese and Western subjects.
No, PF-04171327 is not the same as prednisone. In one clinical trial, PF-04171327 was compared with prednisone to assess their effects on carbohydrate metabolism. PF-04171327 is a separate investigational compound being developed by Pfizer.