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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: cronenberger c. 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 comparative clinical study of PF-06410293, a candidate adalimumab biosimilar, and adalimumab reference product (Humira®) in the treatment of active rheumatoid arthritis.
Fleischmann RM, Alten R, Pileckyte M, Lobello K, Hua SY, Cronenberger C, Alvarez D, Bock AE, Sewell KL. Fleischmann RM, et al. Among authors: cronenberger c. Arthritis Res Ther. 2018 Aug 15;20(1):178. doi: 10.1186/s13075-018-1676-y. Arthritis Res Ther. 2018. PMID: 30111357 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: cronenberger c. BioDrugs. 2020 Apr;34(2):197-207. doi: 10.1007/s40259-019-00403-z. BioDrugs. 2020. PMID: 31939063 Free PMC article. Clinical Trial.
Randomized, Open-Label, Single-Dose, Parallel-Group Pharmacokinetic Study of PF-06410293 (adalimumab-afzb), an Adalimumab Biosimilar, by Subcutaneous Dosing Using a Prefilled Syringe or a Prefilled Pen in Healthy Subjects.
Cox DS, Alvarez DF, Bock AE, Cronenberger CL. Cox DS, et al. Among authors: cronenberger cl. Clin Pharmacol Drug Dev. 2021 Oct;10(10):1166-1173. doi: 10.1002/cpdd.939. Epub 2021 Mar 25. Clin Pharmacol Drug Dev. 2021. PMID: 33765358 Free PMC article. Clinical Trial.
Randomised study of PF-06410293, an adalimumab (ADL) biosimilar, compared with reference ADL for the treatment of active rheumatoid arthritis: results from weeks 26-52, including a treatment switch from reference ADL to PF-06410293.
Fleischmann RM, Alvarez DF, Bock AE, Cronenberger C, Vranic I, Zhang W, Alten R. Fleischmann RM, et al. Among authors: cronenberger c. RMD Open. 2021 Apr;7(2):e001578. doi: 10.1136/rmdopen-2021-001578. RMD Open. 2021. PMID: 33883254 Free PMC article. Clinical Trial.
Long-term efficacy, safety, and immunogenicity of the adalimumab biosimilar, PF-06410293, in patients with rheumatoid arthritis after switching from reference adalimumab (Humira®) or continuing biosimilar therapy: week 52-92 data from a randomized, double-blind, phase 3 trial.
Fleischmann RM, Alvarez DF, Bock AE, Cronenberger C, Vranic I, Zhang W, Alten R. Fleischmann RM, et al. Among authors: cronenberger c. Arthritis Res Ther. 2021 Sep 25;23(1):248. doi: 10.1186/s13075-021-02626-4. Arthritis Res Ther. 2021. PMID: 34563243 Free PMC article. Clinical Trial.
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.
Fleischmann RM, Saikali W, Lakhanpal S, Alvarez DF, Cox DS, Ianos CA, Zhang W, Cronenberger C, Wang K. Fleischmann RM, et al. Among authors: cronenberger c. Lancet Rheumatol. 2023 Sep;5(9):e532-e541. doi: 10.1016/S2665-9913(23)00161-3. Epub 2023 Aug 21. Lancet Rheumatol. 2023. PMID: 38251497 Clinical Trial.
20 results