Xue, Yu
Hu, Jiankang
Liu, Dongzhou
Li, Jingyang
Wu, Huaxiang
Tan, Chunyu
Dai, Lie
Sun, Lingyun
Li, Zhijun
Xiao, Zhengyu
Huang, Cibo
Yan, Yan
Ji, Fei
Chen, Rong
Zou, Hejian http://orcid.org/0000-0001-9762-2663
Clinical trials referenced in this document:
Documents that mention this clinical trial
Ixekizumab for Active Radiographic Axial Spondyloarthritis in Chinese Patients: 16- and 52-Week Results from a Phase III, Randomized, Double-Blind, Placebo-Controlled Study
https://doi.org/10.1007/s40259-023-00625-2
Funding for this research was provided by:
Eli Lilly and Company
Article History
Accepted: 11 September 2023
First Online: 22 September 2023
Declarations
:
: Sponsorship for this study was provided by Eli Lilly and Company.
: Dongzhou Liu and Cibo Huang received research grants from Eli Lilly and Company. Yan Yan and Rong Chen are employees and shareholders of Eli Lilly and Company. Fei Ji was an employee and shareholder of Eli Lilly and Company during the period of this work. Yu Xue, Jiankang Hu, Jingyang Li, Huaxiang Wu, Chunyu Tan, Lie Dai, Lingyun Sun, Zhijun Li, Zhengyu Xiao, and Hejian Zou have no conflicts of interest to declare in relation to this work.
: The study protocol was approved by local ethics committees and the study was conducted in accordance with the principles outlined in the Declaration of Helsinki and the Council of International Organizations of Medical Sciences International Ethical Guidelines.
: All patients gave written, informed consent before participating in the study.
: Not applicable.
: Lilly provides access to all individual participant data collected during the trial, after anonymization, with the exception of pharmacokinetic or genetic data. Data are available upon reasonable request. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data-sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, and blank or annotated case report forms, will be provided in a secure data-sharing environment. For details on submitting a request, see the instructions provided at ExternalRef removed.
: Not applicable.
: All named authors of this article meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship, take responsibility for the integrity of the work as a whole, and have provided approval for this version to be published. All authors contributed to the study conception and design. Hejian Zou, Yu Xue, Jiankang Hu, Dongzhou Liu, Jingyang Li, Huaxiang Wu, Chunyu Tan, Lie Dai, Lingyun Sun, Zhijun Li, Zhengyu Xiao and Cibo Huang contributed to the acquisition of data. Fei Ji contributed to data analysis. Substantial contributions to the interpretation of data were provided by all authors. The first draft of the manuscript was written by Jake Burrell, PhD, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.
: Partial results presented in this manuscript were presented as posters at the American College of Rheumatology (ACR) Congress 2022 (10–14 November 2022) and the Asia-Pacific League of Associations for Rheumatology (APLAR) congress 2022 (6–9 December 2022).