Pappas, Dimitrios A. http://orcid.org/0000-0001-8338-027X
Litman, Heather J. http://orcid.org/0000-0003-3511-4078
Lesperance, Tamara
Kricorian, Greg http://orcid.org/0000-0002-9419-9836
Karis, Elaine http://orcid.org/0000-0001-8520-2549
Rebello, Sabrina http://orcid.org/0000-0002-0201-4030
Hua, Winnie http://orcid.org/0000-0002-5222-9187
Accortt, Neil A. http://orcid.org/0000-0003-0522-0769
Stryker, Scott http://orcid.org/0000-0002-0404-4487
Funding for this research was provided by:
Amgen Inc.
Article History
Received: 3 February 2020
Accepted: 28 July 2020
First Online: 2 September 2020
Compliance with ethical standards
:
: Dimitrios A. Pappas is an employee of Corrona, LLC; has been a consultant/received honoraria for Novartis, Genentech/Roche, Sanofi/Regeneron, and AbbVie; has equity interest in Corrona, LLC; and is on the board of directors for Corrona Research Foundation. Heather Litman is an employee and shareholder at Corrona, LLC; Tamara Lesperance is a contractor for and has received salary support from Amgen Inc.; Greg Kricorian is an employee and shareholder of Amgen Inc.; Elaine Karis is an employee and shareholder of Amgen Inc.; Sabrina Rebello is an employee of Corrona, LLC. Winnie Hua is an employee of Corrona, LLC. Neil A. Accortt is an employee and shareholder of Amgen Inc. Scott Stryker is an employee and shareholder of Amgen Inc.
: All participating investigators obtained full institutional review board (IRB) approval for human subject research. Sponsor approval and continuing review were obtained through a central IRB (New England Independent Review Board, NEIRB No. 120160610; approved annually on July 28, 2016; July 27, 2017; August 7, 2018; and July 30, 2019). For academic investigative sites without a waiver to use the central IRB, full board approval was obtained from the respective governing IRBs; documentation of approval was submitted to the Sponsor before initiating any study procedures.
: All registry participants provided written informed consent before participating.
: The Corrona dataset is based on a large US multicenter study adhering to a number of institutional review boards, with complex logistics. Patients did not provide consent to raw data sharing during the data collection for this purpose, and the Corrona data sharing policies do not permit raw data sharing for this purpose. An aggregated limited dataset from the current analyses is available to qualified investigators with an approved protocol. Data requests may be sent to Corrona, represented by Dr. Jeffrey D. Greenberg, MD, MPH, New York University School of Medicine, New York, NY, e-mail jgreenberg@corrona.org.