A Comparative Study Between PF-06410293 and Humira® in Combination With Methotrexate in Participants With Active Rheumatoid Arthritis

Phase 3 Completed 455 enrolled Pfizer

RandomizedParallel-groupOpen-labelTreatment

Summary

The study will assess the impact of pharmacokinetics (PK), safety and immunogenicity after switches between PF-06410293 and adalimumab and with continuous dosing with adalimumab in combination with methotrexate in subjects with moderately to severely active rheumatoid arthritis.

Timeline

Start: 2020-01-13
Primary completion: 2021-06-22
Completion: 2021-06-22

Outcome

Met primary endpoint

paper Geometric mean ratios and 90% CIs for AUCτ (105·31, 89·16-124·39) and Cmax (102·56, 89·78-117·17) were within prespecified equivalence margins. PMID 38251497 ↗

Publications

Fleischmann RM, Saikali W, Lakhanpal S, Alvarez DF, Cox DS, Ianos CA, Zhang W, Cronenberger C, Wang K. Multiple switching between the biosimilar adalimumab PF-06410293 and reference adalimumab in patients with active rheumatoid arthritis: a phase 3, open-label, randomised, parallel-group study. Lancet Rheumatol. 2023 Sep;5(9):e532-e541. doi: 10.1016/S2665-9913(23)00161-3. Epub 2023 Aug 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Adalimumab	Monoclonal antibody	40 mg	Subcutaneous
Subject	PF-06410293	Protein / enzyme biologic	40 mg	Subcutaneous