Dalbeth, Nicola
Jones, Graeme
Terkeltaub, Robert
Khanna, Dinesh
Fung, Maple
Baumgartner, Scott
Perez-Ruiz, Fernando
Funding for this research was provided by:
Ardea Biosciences (none)
Article History
Received: 12 September 2018
Accepted: 4 December 2018
First Online: 7 January 2019
Ethics approval and consent to participate
: Institutional review boards (IRBs)/ethics committees (ECs) from each country reviewed and approved the protocol. The central IRBs/ECs were Schulman Associates Institutional Review Board, Inc., Cincinnati, OH, USA; Health and Disability Ethics Committees, Wellington, New Zealand; and Komisja Bioetyczna przy Okregowej Izbie Lekarskiej w Gdańsku, Gdańsk, Poland. The study was performed in compliance with the ethical principles of good clinical practice and according to the International Conference on Harmonisation Harmonised Tripartite Guideline. Patients provided written informed consent to participate in the extension study and had the right to withdraw at any time.
: Not applicable.
: ND has received grant support from AstraZeneca and Amgen and consulting fees for AstraZeneca, Takeda, Horizon, and Kowa. GJ has received grant support from AbbVie, Ardea, Novartis, and Auxilium and has served on advisory boards for Pfizer, Roche, Hospira, and Janssen and speaker’s bureaus for UCB, Roche, Janssen, AbbVie, Novartis, Mundipharma, Amgen, BMS, and Pfizer. RT has received a research grant from AstraZeneca that was transferred to Ironwood for continued funding and has served as consultant to Selecta, Relburn, and SOBI and on advisory boards for Horizon. DK has no conflicts to report. FPR has received grant support from the Spanish Rheumatology Foundation and Cruces Hospital Rheumatologists Association. FPR is a member of the Pharmacy Advisory Commission of the Health Department, Basque Government. FPR has served on speaker’s bureaus for AstraZeneca and Menarini and advisory boards for Amgen, AstraZeneca, Menarini, Metabolex, Novartis, Pfizer, and SOBI. MF and SB are former employees of Ardea Biosciences, Inc., a member of the AstraZeneca group.
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