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

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

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

Indications