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) for private practices, and from respective Research Ethics Boards for institutional sites. 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.
Philip Baer has received consultant fees from AbbVie, Amgen, Janssen, Lilly, Novartis, Boehringer Ingelheim, Pfizer Inc, Sanofi-Genzyme and Merck and speaker’s fees from Amgen, Janssen, Abbvie, Pfizer Inc and Lilly. Ed Keystone received funding for research from AbbVie, Amgen, Gilead Sciences, Lilly Pharmaceuticals, Merck, Pfizer Pharmaceuticals, PuraPharm, Sanofi; consulting agreements/advisory board membership from AbbVie, Amgen, AstraZeneca Pharma, Bristol-Myers Squibb Company, Celltrion, Myriad Autoimmune, F. Hoffmann-La Roche Inc, Genentech Inc, Gilead, Janssen Inc, Lilly Pharmaceuticals, Merck, Pfizer Pharmaceuticals, Sandoz, Sanofi-Genzyme, Samsung Bioepsis; speaker honoraria from Amgen, AbbVie, Bristol-Myers Squibb, Hoffmann-La Roche Inc., Janssen Inc., Merck, Pfizer Pharmaceuticals, Sanofi Genzyme and UCB. Denis Choquette has received consulting and speaking fees from Bristol-Myers Squibb, Abbvie, Amgen, Celgene, Genentech, Amgen, Pfzer, Roche and Novartis. Boulos Haraoui received advisory boards/consulting, and/or received research grants from AbbVie, Amgen, BMS, Celgene, Janssen, Eli Lilly, Merck, Novartis, UCB Pharma and Pfizer. Andrew Chow received advisory boards/consulting, and/or received research grants: AbbVie, Amgen, AstraZeneca, BMS, Celgene, Eli Lilly, Genzyme, GSK, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi Aventis and UCB Pharma. Rafat Faraawi received consultant and speaker fees from Janssen Inc. Wojciech Olszynski received speaker/consultant fees for Amgen, Merck, Novartis, and Warner Chilcott. JPB: research grants, consulting fees, or speakers’ bureau fees from Abbott, Amgen, Bristol Myers Squibb, Eli Lilly, Merck, Novartis, Pfizer, Roche, Sanofi-Aventis, Servier, Takeda, and Warner Chilcott. John Kelsall reports personal fees from Abbott, AstraZeneca, BMS, Merck-Schering, Lilly, Pfizer, Wyeth, Roche, Takeda and UCB. 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), Merck (from 2010-2012) and Janssen Inc. (from 2012-present).
Authors' contributions: PR, PB, EK, CT, DC, BH, AC, RF, WO and JK were involved in recruitment. ER was involved in biostatistical analysis. ER, AJL and ER 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 rheumatoid arthritis who shared their time in the study to help us better understand the impact of their disease.