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Article History

Received: 28 November 2017

Accepted: 8 February 2018

First Online: 23 March 2018

Authors’ information

: RW and AK were the principal investigators of the MTX-add on study and monotherapy study, respectively. PH was the medical lead, and AV the clinical study lead, for both studies.

: Written approval was obtained before initiation of the study from the Medical Ethical Committee of University Hospitals KU Leuven (reference ML9437; study site of the Principal Investigator for DARWIN 1) and the University of California San Diego Human Research Protections Program (reference 140642; study site of the Principal Investigator for DARWIN 2), and from the appropriate independent ethics committee or institutional review board for each of the 106 study centers in DARWIN 1 and 59 study centers in DARWIN 2. Both phase 2b studies were conducted in accordance with the ethical principles of the Declaration of Helsinki, International Council on Harmonisation good clinical practice guidelines, and all applicable national and local laws and regulatory requirements. All patients provided written, informed consent prior to study participation.

: Not applicable.

: L.M., A.V., P.H., and C.T. are employees of Galapagos NV, Belgium. M.G. has received grants from Pfizer, Gilead, Astellas, Vertex, and Eli Lilly and has consulted for Pfizer, Gilead, Astellas, Vertex, Eli Lilly, and Galapagos NV. R.W. received unrestricted research grant from Roche to his institution and was advisor for Jansen (Golimumab) and part of the speakers’ bureau of BMS. A.K. has received compensation for consultancy work, or has been involved in the conduct of clinical research studies, for AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, and UCB and has consulted for Galapagos NV.

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