Výsledky vyhledávání - "Martin, Ullmann"

Akademický článek

Comparison of the efficacy and safety of a proposed biosimilar MSB11456 with tocilizumab reference product in subjects with moderate-to-severe rheumatoid arthritis: results of a randomised double-blind study

Autor: Peter Baker, Anna Zubrzycka-Sienkiewicz, Kamilla Klama, Martin Ullmann, Corinne Petit-Frere, Joëlle Monnet, Andras Illes

Publikováno v: RMD Open, Vol 10, Iss 1 (2024)

Objective To evaluate the efficacy, immunogenicity and safety of the proposed biosimilar MSB11456 versus European Union (EU)-approved tocilizumab reference product in patients with rheumatoid arthritis (RA) in a multicentre, randomised, double-blind,

Externí odkaz: https://doaj.org/article/34072ee0ff6a4c5cb76c4a8cc3281afd

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Akademický článek

Immunogenicity and safety of a proposed pegfilgrastim biosimilar MSB11455 versus the reference pegfilgrastim Neulasta® in healthy subjects: A randomized, double‐blind trial

Autor: Chris Wynne, Christian Schwabe, Emmanuelle Vincent, Armin Schueler, Janka Ryding, Martin Ullmann, Vishal Ghori, Radmila Kanceva, Michael Stahl

Publikováno v: Pharmacology Research & Perspectives, Vol 8, Iss 2, Pp n/a-n/a (2020)

Abstract MSB11455 is a proposed biosimilar to the currently licensed reference pegfilgrastim (Neulasta®). This study was designed primarily to compare the immunogenicity of MSB11455 and Neulasta®. As secondary objectives, the safety and tolerabilit

Externí odkaz: https://doaj.org/article/7beea784365047a58e0ab0cad4fdf7c7

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Pharmacokinetics and pharmacodynamics of a proposed tocilizumab biosimilar MSB11456 versus both the US-licensed and EU-approved products: a randomized, double-blind trial

Autor: Christian Schwabe, Andras Illes, Martin Ullmann, Vishal Ghori, Emmanuelle Vincent, Corinne Petit-Frere, Joelle Monnet, Anne Sophie Racault, Chris Wynne

Tocilizumab is a recombinant humanized monoclonal immunoglobulin G1 antibody against the interleukin-6 receptor (IL-6 R). MSB11456 is a proposed tocilizumab biosimilar. To assess the pharmacokinetic and pharmacodynamic similarity of MSB11456 to both

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5467200e265670149b1e8f673c90bc57

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AURIEL ‐PsO: a randomized, double‐blind phase III equivalence trial to demonstrate the clinical similarity of the proposed biosimilar MSB 11022 to reference adalimumab in patients with moderate‐to‐severe chronic plaque‐type psoriasis

Autor: V. Chyrok, Kim A. Papp, Jana Hercogová, Pantelis Vlachos, Martin Ullmann, Christopher J Edwards

Publikováno v: British Journal of Dermatology. 182:316-326

Background MSB11022 is a proposed adalimumab biosimilar. Objectives To compare the efficacy, safety and immunogenicity of MSB11022 with reference adalimumab. Methods AURIEL-PsO was a double-blind randomized controlled equivalence trial, in which pati

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::a459157e2db665325bad6890ec93a782
https://doi.org/10.1111/bjd.18220

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FRI0088 SAFETY, IMMUNOGENICITY AND EFFICACY OF THE PROPOSED BIOSIMILAR MSB11022 (MODIFIED FORMULATION) COMPARED WITH ADALIMUMAB REFERENCE PRODUCT IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS: AURIEL-RA, A RANDOMISED, DOUBLE-BLIND, PHASE III STUDY

Autor: Martin Ullmann, Joëlle Monnet, Christopher J Edwards, Pantelis Vlachos, Veronica Chyrok

Publikováno v: Poster Presentations.

Background: Adalimumab is a fully human anti-TNF monoclonal antibody indicated for the treatment of multiple inflammatory disorders, including rheumatoid arthritis (RA). MSB11022 is a proposed adalimumab biosimilar that has been shown to be structura

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::c80cc29f068f9bb31ec27174f47305b4
https://doi.org/10.1136/annrheumdis-2019-eular.4220

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Immunogenicity and safety of a proposed pegfilgrastim biosimilar MSB11455 versus the reference pegfilgrastim Neulasta® in healthy subjects: A randomized, double‐blind trial

Autor: Armin Schueler, Michael Stahl, Christian Schwabe, Radmila Kanceva, Vishal Ghori, Janka Ryding, Chris Wynne, Emmanuelle Vincent, Martin Ullmann

Publikováno v: Pharmacology Research & Perspectives, Vol 8, Iss 2, Pp n/a-n/a (2020)

MSB11455 is a proposed biosimilar to the currently licensed reference pegfilgrastim (Neulasta®). This study was designed primarily to compare the immunogenicity of MSB11455 and Neulasta®. As secondary objectives, the safety and tolerability of MSB1

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7ddea1919d30b7b20327a9db012f413e
https://doaj.org/article/7beea784365047a58e0ab0cad4fdf7c7

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AB0195 PHARMACOKINETIC AND PHARMACODYNAMIC EVALUATION OF A PROPOSED BIOSIMILAR MSB11456 VERSUS BOTH THE US-LICENSED AND EU-APPROVED TOCILIZUMAB: RESULTS OF A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, SINGLE-DOSE TRIAL IN HEALTHY ADULTS

Autor: A. S. Racault, C. Wynne, V. Ghori, Christian Schwabe, Martin Ullmann, A. Illes, C. Petit-Frere, I. Morin, E. Vincent

Publikováno v: Annals of the Rheumatic Diseases. 80:1121.2-1122

Background:Tocilizumab, a biologic disease-modifying antirheumatic drug, is a recombinant humanized monoclonal immunoglobulin G1 antibody against the interleukin-6 receptor (IL-6R). MSB11456 is a proposed biosimilar to the US-licensed tocilizumab and

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::167002b3aba5202af63d54e695ceb4c8
https://doi.org/10.1136/annrheumdis-2021-eular.74

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