Koehm, Michaela
McIntosh, Matthew J.
Hofmann, Michael W.
Abraham, Varghese
Gabay, Cem
Choy, Ernest H.
Kavanaugh, Arthur
Burkhardt, Harald
Behrens, Frank
Funding for this research was provided by:
Chugai Pharma Europe Ltd.
Article History
Received: 15 October 2019
Accepted: 6 January 2020
First Online: 10 February 2020
Compliance with ethical standards
:
: MK, CG, EHC, AK, HB, and FB received research grants or speaker fees from Chugai, which markets tocilizumab in some countries. MJM is an employee of Genentech, a corporate partner of Chugai, and VA is a former employee of Genentech. MWH is an employee of Chugai. EHC has received research grants and served as member of advisory boards and speaker bureaus of Abbvie, Amgen, Bio-Cancer, Biogen, Bristol Myer Scripps, Boehringer Ingelheim, Celgene, Chugai Pharma, Eli Lilly, Hospira, Janssen, Napp, Novimmune, Novartis, ObsEva, Pfizer, Regeneron, Roche, R-Pharm, Sanofi, SynAct Pharma, Synovate, Tonix. and UCB.
: These previously published studies were conducted in accordance with the Declaration of Helsinki and International Conference on Harmonisation Guidelines for Good Clinical Practice and were approved by an ethics committee or institutional review board at each center (ACT-iON: North Wales Research Ethics Committee, Nov. 25, 2011, REC reference 11/WA/0355; ADACTA: University Hospital of Geneva Ethics Committee WA19924). Because this was a retrospective analysis of previously collected anonymous data, additional ethics approval and consent were not required.
: Informed consent was obtained from all individual participants included in the study.
: Qualified researchers may request access to individual patient level data through the clinical study data request platform (ExternalRef removed). Further details on Roche's criteria for eligible studies are available here (ExternalRef removed). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (ExternalRef removed).