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Also known as Infliximab-Pfizer
PF-06438179 · 1 trial · 1 indication
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 | - |
| 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. |
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 being developed for the treatment of rheumatoid arthritis. It is a monoclonal antibody studied in adults with active rheumatoid arthritis, specifically in combination with methotrexate. The clinical program has focused on this immunology indication, and the drug remains investigational.
PF-06438179 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of the clinical program for this monoclonal antibody in rheumatoid arthritis.
PF-06438179 has completed a Phase 3 clinical trial in rheumatoid arthritis. It is an investigational monoclonal antibody and has not been approved by the FDA for any indication. The Phase 3 study has finished, and no active trials are currently listed for this asset.
PF-06438179 was evaluated in the Phase 3 REFLECTIONS B537-02 study, registered as NCT02222493. That randomized, double-blind, active-controlled trial enrolled 650 adults with active rheumatoid arthritis and tested PF-06438179 plus methotrexate against infliximab plus methotrexate. The study is completed and ran across the United States, Europe, Asia, Latin America, Africa, and Australia.
PF-06438179 is also known as infliximab-Pfizer. It is a proposed biosimilar candidate referencing infliximab, studied in rheumatoid arthritis. The REFLECTIONS B537-02 trial compared PF-06438179 plus methotrexate with infliximab plus methotrexate in adults with active rheumatoid arthritis.