The authors thank the patients, the investigators, and the study personnel who made this trial possible. The authors also thank Michelle Perate, MS, and Mary Whitman, PhD, of Janssen Scientific Affairs, LLC, who helped prepare and submit the manuscript. The authors also thank the following institutional review boards/ethics committees: China Medical University Hospital Instituted Review of Board 9 F, Taichung, Taiwan, Republic of China; Comité de Protection des Personnes Ile-de-France III, Hôpital Tarnier-Cochin 89, Paris, France; Commissie Medische ethiek van de Universitaire Ziekenhuizen KU Leuven/U.Z. Gasthuisberg, Leuven, Belgium; Ethikkommission der ärztekammer Westfalen-Lippe und der Medizinischen Fakultät der WWU Münster, Münster, Germany; Human Experiment and Ethics Committee, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan, Republic of China; HUS Helsingin ja Uudenmaan sairaanhoitopiiri, Medisiininen eettinen toimikunta, Biomedicum Helsinki, HUS, Finland; Institutional Review Board, Biomedical Research Institute, Seoul National University Hospital, Jongro-gu, Seoul, South Korea; Institutional Review Board, Dong-A University Hospital Clinical Research Center, Seo-Gu, Busan, South Korea; Institutional Review Board, Guro Hospital, Korea University Medical Center, Guro-Gu, Seoul, South Korea; Institutional Review Board, Hanyang University Hospital, Sungdong-Ku, Seoul, South Korea; Institutional Review Board, Pusan National University Hospital, Seo-Gu, Busan, South Korea; Institutional Review Board, Seoul St. Mary’s Hospital/The Catholic University of Korea, Seocho-gu, Seoul, South Korea; Joint Institutional Review Board. No. 201, Taipei, Taiwan, Republic of China; METC azM/UM Maastricht, Maastricht, The Netherlands; and Western Institutional Review Board, Olympia, WA, USA.
Funding
This study was funded by Janssen Research & Development, LLC, and Merck/Schering-Plough.
Authors’ contributions
RDI made substantial intellectual contributions to the study conception and data interpretation, helped draft and revise the manuscript for important intellectual content, approved the final version to be published, and agreed to be accountable for all aspects of the work. XB made substantial intellectual contributions to the study conception and data interpretation, revised the manuscript for important intellectual content, approved the final version to be published, and agreed to be accountable for all aspects of the work. KGAH made substantial intellectual contributions to the study conception and data interpretation, revised the manuscript for important intellectual content, approved the final version to be published, and agreed to be accountable for all aspects of the work. JB made substantial intellectual contributions to the study conception and data interpretation, revised the manuscript for important intellectual content, approved the final version to be published, and agreed to be accountable for all aspects of the work. AD made substantial intellectual contributions to the study conception and data interpretation, revised the manuscript for important intellectual content, approved the final version to be published, and agreed to be accountable for all aspects of the work. DvdH made substantial intellectual contributions to the study conception and data interpretation, revised the manuscript for important intellectual content, approved the final version to be published, and agreed to be accountable for all aspects of the work. SX made substantial intellectual contributions to the data analysis and interpretation, helped to draft and revise the manuscript for important intellectual content, approved the final version to be published, and agreed to be accountable for all aspects of the work. BH made substantial intellectual contributions to the study conception and design, data acquisition, and data analysis/interpretation; helped to draft and revise the manuscript for important intellectual content; approved the final version to be published; and agreed to be accountable for all aspects of the work. All authors read and approved the final manuscript.
Competing interests
No nonfinancial conflicts of interest exist for any authors. RDI has received consulting fees from Janssen, Merck, AbbVie, Amgen, and UCB. XB has received honoraria for talks and serving on advisory boards as well as grants for studies from AbbVie, Amgen, Janssen Research & Development, MSD (Schering-Plough), Novartis, Pfizer (Wyeth), and UCB. KGAH has received honoraria for educational lectures from Abbott, Janssen Research & Development, MSD (Schering-Plough), Pfizer (Wyeth), and UCB. JB has received honoraria for talks and serving on advisory boards as well as grants for studies from Celltrion, Amgen, Abbott, Roche, Bristol-Myers Squibb, Janssen, Novartis, Pfizer (Wyeth), MSD (Schering-Plough), Sanofi-Aventis, and UCB. AD has received research grants and has served on the advisory boards of AbbVie, Amgen, Janssen, Pfizer, Novartis, and UCB. These potential conflicts of interest have been reviewed and managed by Oregon Health & Science University. DvdH has received consulting fees from AbbVie, Amgen, AstraZeneca, Augurex, Bristol-Myers Squibb, Celgene, Chugai Pharmaceutical Co., Covagen, Daiichi Sankyo, Eli Lilly, Galapagos, GSK, Janssen Biologics, Merck, Novartis, Novo Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, UCB, and Vertex, and is director of imaging rheumatology, Leiden University Medical Center. SX and BH are employees of Janssen Research & Development, LLC
Ethics approval and consent to participate
The GO-RAISE study protocol was reviewed and approved by the institutional review board or independent ethics committee at each site of this multicenter trial and was conducted according to the principles of the Declaration of Helsinki and good clinical practice. All patients provided written informed consent before the conduct of any study-related procedures.