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Article History

First Online: 16 September 2019

Compliance with Ethical Standards

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: This study was sponsored by Merck KGaA, Darmstadt, Germany.

: Daniela Willen, Wolfgang Uhl and Peter Wolna were employees of Merck KGaA, Darmstadt, Germany at the time of this study. Özkan Yalkinoglu is an employee of Merck KGaA, Darmstadt, Germany. Orestis Papasouliotis is an employee of Merck Institute for Pharmacometrics, Lausanne, Switzerland, an affiliate of Merck KGaA, Darmstadt, Germany.

: The protocol was approved by the Office for Research Ethics Committees Northern Ireland and the study was conducted at the Quintiles Drug Research Unit, Guy’s Hospital, in the UK (EudraCT ID: 2013-002703-34; study: EMR 700461-022), in accordance with the International Conference on Harmonization Guidelines for Good Clinical Practice, the Declaration of Helsinki, the European Union Clinical Trial Directive, and all applicable local regulatory requirements.

: Atacicept is under clinical investigation and has not yet been approved in any sought-after indication by any health authority worldwide. Therefore, there is no plan for data sharing at this point in time. Please note that for all new products or new indications approved in both the European Union and the United States after January 1, 2014, Merck will share patient level, study level data after de-identification, as well as redacted study protocols and clinical study reports from clinical trials in patients. These data will be shared with qualified scientific and medical researchers, upon researcher’s request, as necessary for conducting legitimate research. Such requests must be submitted in writing to the company’s data sharing portal and will be internally reviewed regarding criteria for researcher qualifications and legitimacy of the research purpose ().