Harrold, Leslie R. https://orcid.org/0000-0002-0170-2747
Wittstock, Keith
Kelly, Sheila
Han, Xue
Zhuo, Joe
Schrader, Amy
Middaugh, Nicole
Moore, Page C.
Khaychuk, Vadim
Article History
Received: 9 February 2023
Accepted: 9 January 2024
First Online: 19 January 2024
Declarations
:
: The study was performed in accordance with the Declaration of Helsinki and the Guidelines for Good Pharmacoepidemiology Practice (GPP). All participating investigators were required to obtain full board approval for conducting noninterventional research involving human subjects with a limited dataset. Sponsor approval and continuing review was obtained through a central Institutional Review Board (IRB), the New England Independent Review Board (NEIRB; no. 120160610). For academic investigative sites that did not receive authorization to use the central IRB, full board approval was obtained from their respective governing IRBs, and documentation of approval was submitted to CorEvitas, LLC before the site’s participation and initiation of any study procedures. All patients in the registry were required to provide written informed consent and authorization before participating.
: All the results presented in the manuscript are in aggregate form and no personal identifiable information was used for this study.
: A portion of this data was presented at ACR Convergence 2021, Virtual, November 5–9, 2021.
: Leslie R. Harrold: employee, shareholder: CorEvitas, LLC; consulting fees: AbbVie, Bristol Myers Squibb, Roche; Speakers Bureau: Bristol Myers Squibb; Keith Wittstock, Vadim Khaychuk: employees: Bristol Myers Squibb. Sheila Kelly, Joe Zhou: employees, shareholders; Bristol Myers Squibb. Xue Han former employee of Bristol Myers Squibb; Amy Schrader, Nicole Middaugh, Page C. Moore employees: CorEvitas, LLC.