Feldman, Steven R.
Reznichenko, Nataliya
Pulka, Grazyna
Kingo, Külli
George Galdava,
Berti, Fausto
Sobierska, Joanna
Dias, Roshan
Guenzi, Eric
Hendrik Otto,
Haliduola, Halimu N.
Kay, Richard
Stroissnig, Heimo
Clinical trials referenced in this document:
Documents that mention this clinical trial
Efficacy, Safety and Immunogenicity of AVT02 Versus Originator Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis: A Multicentre, Double-Blind, Randomised, Parallel Group, Active Control, Phase III Study
https://doi.org/10.1007/s40259-021-00502-w
Article History
Accepted: 7 October 2021
First Online: 16 October 2021
Declarations
:
: The study was sponsored by Alvotech Swiss AG. Employees of the sponsor had a role in study design, data analysis and manuscript preparation. Employees of the funder had no role in data collection.
: FB, JS, RD, EG, HO, HNH and HS are employees at Alvotech. SF has received research grants from Abbvie, Janssen, Lilly and Novartis and speaker honoraria from Alvotech, Abbvie, Amgen, Lilly, Novartis and Janssen. RK's company has received consultancy fees in relation to this study and in other studies conducted by Alvotech, but no consultancy fees have been received in relation to the writing of this manuscript. NR, GP, KK, and GG declare that they have no conflicts of interest that might be relevant to this work.
: The datasets generated and/or analysed during the current study are available from the sponsor on reasonable request.
: Not applicable.
: The study was conducted in accordance with the Declaration of Helsinki, the International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines and the appropriate regulatory requirements in the countries in which the study was conducted. The protocol, its amendments and informed consent documentation were reviewed and approved by the institutional review board(s) or independent ethics committee(s) at each study site.
: All patients signed an Institutional Review Board/Independent Ethics Committee-approved informed consent form before any study-specific procedures were performed.
: Not applicable.
: SRF, FB, JS, EG, HO, HNH, RK and HS were involved in the conception and design of the study. NR, GP, KK, GG, JS and RD were involved in the provision of study materials and patients and acquisition of the data. SRF, FB, JS, HO, HNH and HS did the analysis and/or the interpretation of the data. All authors revised the report critically. All authors approved the final version.