Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-06438179 · 2 trials · 2 indications
ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count (TJC); \>= 20% improvement in swollen joint count (SJC); and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity (PGA); physician global assessment of disease activity; self-assessed disability (health assessment questionnaire-disability index \[HAQ-DI\]); and C-Reactive Protein (CRP).
| Arm | Type | Description |
|---|---|---|
| PF-06438179 | EXPERIMENTAL | - |
| Infliximab | ACTIVE_COMPARATOR | - |
| A = PF-06438179 | EXPERIMENTAL | - |
| B = Infliximab-EU | ACTIVE_COMPARATOR | - |
| C = Infliximab-US | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| PF-06438179 | BIOLOGICAL | PF-06438179 will be administered by intravenous infusion at an initial dose of 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. |
| Infliximab | BIOLOGICAL | Infliximab will be administered by intravenous infusion at an initial dose of 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. |
| Remicade | BIOLOGICAL | Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1 |
Inclusion Criteria: Diagnosis of rheumatoid arthritis based on 2010 ACR/EULAR criteria for at least 4 months. At least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening and baseline. HS-CRP equal or greater than 10 mg/L. Must have received methotrexate for at least 12 ...
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PF-06438179 is an investigational monoclonal antibody being studied for use in rheumatoid arthritis and in healthy volunteers. In clinical trials, it is being evaluated in combination with methotrexate for active rheumatoid arthritis, and as a pharmacokinetics study in healthy subjects.
PF-06438179 is a monoclonal antibody that targets tumor necrosis factor (TNF). It is being developed as a potential biosimilar to infliximab, and its mechanism involves binding to TNF to modulate inflammatory responses.
PF-06438179 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug's safety and efficacy.
PF-06438179 is in Phase 1 clinical development. While one Phase 3 trial has been completed, the overall development program is currently in Phase 1, and the drug remains investigational and not yet approved.
PF-06438179 has been studied in two completed trials. NCT01844804 is a Phase 1 pharmacokinetics study in healthy volunteers, and NCT02222493 is a Phase 3 study in rheumatoid arthritis patients. Both trials are completed.
PF-06438179 is being studied as a potential biosimilar to infliximab, meaning it is designed to be highly similar to the reference product. However, it is a distinct investigational drug and has not been approved as interchangeable with infliximab.