Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Adalimumab-Pfizer
PF-06410293 · 2 trials · 1 indication
Cmax refers to maximum observed serum concentration of drug. The geometric coefficient of variation is expressed in percentage.
Area under the serum concentration curve from time 0 to end of dosing interval (tau), where dosing interval was once every two weeks. The geometric coefficient of variation is expressed in percentage.
ACR20 is a categorical variable indicating a 20% or greater improvement in tender and swollen joint counts and 20% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).
| Arm | Type | Description |
|---|---|---|
| Treatment Arm 1 | EXPERIMENTAL | Subcutaneous (SC) injection given every other week |
| Treatment Arm 2 | ACTIVE_COMPARATOR | SC injection given every other week |
| PF-06410293 | EXPERIMENTAL | - |
| Adalimumab | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| PF-06410293 | DRUG | SC injection |
| adalimumab | DRUG | SC injection |
Inclusion Criteria: * Diagnosis of RA based on 2010 ACR/EULAR for RA for at least a 4 month duration. * Moderately to severely active RA based on local standard of care. Exclusion Criteria: -Evidence of untreated or inadequately treated latent or active TB.
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PF-06410293 is being developed for the treatment of rheumatoid arthritis. It is studied in adults with active rheumatoid arthritis and is given in combination with methotrexate. Both of its Phase 3 trials enrolled participants 18 years and older with active disease.
PF-06410293 is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the sponsor of both Phase 3 trials evaluating the drug in rheumatoid arthritis.
PF-06410293 is in Phase 3 development. It is investigational and has been studied in two completed Phase 3 trials in rheumatoid arthritis. Both trials are now finished, and neither is currently recruiting or active.
PF-06410293 has been evaluated in two completed Phase 3 trials. NCT02480153, also called REFLECTIONS B538-02, enrolled 597 participants, and NCT04230213 enrolled 455 participants. Both studied the drug with methotrexate in active rheumatoid arthritis across multiple countries.
PF-06410293 is a small molecule developed as a proposed adalimumab biosimilar. It is designed to correspond to adalimumab, the active ingredient in Humira, and is studied in combination with methotrexate in patients with active rheumatoid arthritis.
Yes. PF-06410293 is also referred to as adalimumab-pfizer. That alternative name appears in the title of the Phase 3 trial NCT02480153, which evaluated PF-06410293 and adalimumab (Humira) with methotrexate in participants with active rheumatoid arthritis.