Ethics and Consent to participate: Prior to enrollment, patients were required to provide written informed consent to participate. Ethics approval was obtained from a central Research Ethics Board (IRB Service, Ontario, Canada now under the name of Advarra) for private practices (registered with OHRP and FDA as follows: ON IRB registration #IRB00000776, QC IRB registration #IRB00005290, and from respective Research Ethics Boards for institutional sites (Sunnybrook Health Sciences Centre REB, Winnipeg Clinical Ethics Committee , Mount Sinai Hospital REB, University of BC BCCA REB, CHUS Centre de Recherche, HREA, HREBA (Health Research Ethics Board of Alberta), Horizon Health Network REB, Hopital Maisonneuve Rosemont. The study was conducted in accordance with the Declaration of Helsinki.
Consent for Publication: Not applicable
Availability of data and material: Janssen has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for CSRs and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. For more information on this process or to make a request, please go to https://yoda.yale.edu/.
Competing Interests: Proton Rahman has received consulting fees for Abbott, AbbVie, Amgen, BMS, Celgene, Janssen, Novartis, Pfizer and Roche; and received research grant from Janssen. Michael Starr received consultant fees from Janssen, AbbVie, Novartis, Sanofi, Pfizer, BMS and Lilly. Derek Haaland received grant/research support, sponsored study funding and speaker fees from Janssen. Louis Bessette received speaker fees from Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Lilly and Novartis; consultant fees from Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Celgene, Lilly and Novartis and research grants from Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly and Novartis. Michelle Teo received research support and consulting fees from Janssen. Allen Lehman and Francois Nantel are employees of Janssen Inc. and are JNJ stockholders.
Funding: This study was financed in its entirety and managed by Schering-Plough (from 2002-2010; study design and data collection), Merck (from 2010-2012; study amendment, design and data collection) and Janssen Inc. (from 2012-present; study amendment, design, data collection, analysis, interpretation and writing).
Authors’ contributions: PR, MS, DH, LB and MT were involved in recruitment. ER was involved in biostatistical analysis. ER, AJL and FN were involved in the study design and FN wrote the manuscript. All authors were involved in data analysis, reviewed and edited the manuscript and approved the final version.
Acknowledgements: This study is dedicated to the memory of William G. Bensen MD, who was BioTRAC’s primary investigator from its inception in 2002 until his premature passing on March 15th, 2017. The authors are indebted to the BioTRAC investigators, nurses, study coordinators and to the individuals who were involved in its design, management, data generation and dissemination: Vincent Letourneau, John Leombruno, Hayssam Khalil, Chad Mitchell, Sophie-Elise Michaud, Frank Hack, Nader Khabboul, Heidi Imhoff, Susan Otawa, May Shawi, Kathy Tkaczyk, Karina Maslova, Brendan Osborne, Odalis Asin-Milan, Meagan Rachich, John S. Sampalis, Eliofotisti Psaradellis, Nadia Longo, Julie Vaillancourt, Angela Karellis, Saliha Boumaza, Patricia Bandeira, Karen Landers, Clara Fehrmann, Julie Dinniwell, Debra Mitchell and Sandra Sitar. We also wish to thank all the people living with ankylosing spondylitis who shared their time in the study to help us better understand the impact of their disease.