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Randomised, double-blind, phase III study comparing the infliximab biosimilar, PF-06438179/GP1111, with reference infliximab: efficacy, safety and immunogenicity from week 30 to week 54.
Alten R, Batko B, Hala T, Kameda H, Radominski SC, Tseluyko V, Babic G, Cronenberger C, Hackley S, Rehman M, von Richter O, Zhang M, Cohen S. Alten R, et al. Among authors: rehman m. RMD Open. 2019 Mar 28;5(1):e000876. doi: 10.1136/rmdopen-2018-000876. eCollection 2019. RMD Open. 2019. PMID: 30997153 Free PMC article. Clinical Trial.
A randomized controlled trial comparing PF-06438179/GP1111 (an infliximab biosimilar) and infliximab reference product for treatment of moderate to severe active rheumatoid arthritis despite methotrexate therapy.
Cohen SB, Alten R, Kameda H, Hala T, Radominski SC, Rehman MI, Palaparthy R, Schumacher K, Schmitt S, Hua SY, Ianos C, Sewell KL. Cohen SB, et al. Arthritis Res Ther. 2018 Jul 27;20(1):155. doi: 10.1186/s13075-018-1646-4. Arthritis Res Ther. 2018. PMID: 30053896 Free PMC article. Clinical Trial.
Long-term Efficacy, Safety, and Immunogenicity of the Infliximab (IFX) Biosimilar, PF-06438179/GP1111, in Patients with Rheumatoid Arthritis After Switching from Reference IFX or Continuing Biosimilar Therapy: Week 54-78 Data From a Randomized, Double-Blind, Phase III Trial.
Cohen SB, Radominski SC, Kameda H, Kivitz AJ, Tee M, Cronenberger C, Zhang M, Hackley S, Rehman MI, von Richter O, Alten R. Cohen SB, et al. Among authors: rehman mi. BioDrugs. 2020 Apr;34(2):197-207. doi: 10.1007/s40259-019-00403-z. BioDrugs. 2020. PMID: 31939063 Free PMC article. Clinical Trial.
A comparative study of PF-06438179/GP1111 (an infliximab biosimilar) and reference infliximab in patients with moderate to severe active rheumatoid arthritis: A subgroup analysis.
Kameda H, Uechi E, Atsumi T, Abud-Mendoza C, Kamei K, Matsumoto T, Ponce de Leon D, Rehman MI, Zhang M, Radominski SC. Kameda H, et al. Among authors: rehman mi. Int J Rheum Dis. 2020 Jul;23(7):876-881. doi: 10.1111/1756-185X.13846. Epub 2020 May 31. Int J Rheum Dis. 2020. PMID: 32476277 Free PMC article. Clinical Trial.
The 'totality-of-the-evidence' approach in the development of PF-06438179/GP1111, an infliximab biosimilar, and in support of its use in all indications of the reference product.
McClellan JE, Conlon HD, Bolt MW, Kalfayan V, Palaparthy R, Rehman MI, Kirchhoff CF. McClellan JE, et al. Therap Adv Gastroenterol. 2019 Jun 13;12:1756284819852535. doi: 10.1177/1756284819852535. eCollection 2019. Therap Adv Gastroenterol. 2019. PMID: 31223341 Free PMC article. Review.
1,423 results