The authors thank Leslie Whitehead for her editorial assistance. Corrona would like to thank the participating rheumatologists and their patients for contributing data.
This study is sponsored by Corrona, LLC. The Corrona RA registry has been supported through contracted subscriptions in the last 2 years by AbbVie, Amgen, Astra Zeneca, BMS, Crescendo, Genentech, Horizon Pharma USA, Janssen, Eli Lilly, Novartis, Pfizer, and UCB.
Availability of data and materials
The data that support the findings of this study are available through Corrona, LLC but restrictions apply to the availability of these data, which were used under a subscription agreement for the current study, and so are not publicly available.
LRH and GWR had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. LRH was involved in study design, study management, study analysis and interpretation, and preparing the outline of the first draft of the manuscript, and was responsible for the overall conduct of the study. GWR was involved in study design, conduction of the study, supervision of the statistical analysis, and interpretation and presentation of the results. ML was involved in study design, study analyses, interpretation of the results, and presentation of the results. DHS was involved in the study design, study analyses, and interpretation and presentation of the results. JRC was involved in the study design, study analyses, interpretation of the results, and presentation of the results. JDG was involved in data collection and data interpretation. JMK was involved in data collection and data interpretation. All authors were involved in the drafting, critical review, and approval of all versions of the manuscript, its content and its submission, and take public responsibility for appropriate portions of the content.
LRH received grant funding from Pfizer; is consultant to Roche; and is a Corrona, LLC employee with stock options and employee of University of Massachusetts Medical School. GWR received financial support from Corrona, LLC and is an employee with stock options; and has an appointment at the University of Massachusetts Medical School. DHS received research grants from Amgen, Lilly, and Corrona; and has unpaid positions in a trial sponsored by Pfizer, Novartis, Lilly, and BMS. JRC received grant/research support from Roche/Genentech, UCB, Janssen, Corrona, Amgen, Pfizer, BMS, Crescendo, and AbbVie; and is a consultant for Roche/Genentech, UCB, Janssen, Corrona, Amgen, Pfizer, BMS, Crescendo, and AbbVie. ML is a Corrona, LLC employee. JDG received financial support from Corrona, LLC and is an employee and shareholder; and is a consultant to AstraZeneca, Celgene, Genentech, Janssen, Novartis, and Pfizer. JMK is a Corrona, LLC employee with stock options; and a consultant for AbbVie, Amgen, BMS, Genentech, Lilly, and Pfizer.
Consent for publication
All results presented in this manuscript are in aggregate form and no personal identifiable information was used for this study.
Ethics approval and consent to participate
All participating investigators were required to obtain full board approval for conducting research involving human subjects. Sponsor approval and continuing review was obtained through a central IRB (New England Independent Review Board, NEIRB No. 02-021). For academic investigative sites that did not receive a waiver to use the central IRB, full board approval was obtained from the respective governing IRBs and documentation of approval was submitted to the Sponsor prior to initiating any study procedures. All registry subjects were required to provide written informed consent prior to participating. The Principal Investigator or designee at each site will inform patients of the purposes of this registry. Patients who express a willingness to consider participation will be given a consent form to review. If patients have any questions related to participation in the registry these will be answered by the Principal Investigator or designee. Patients will sign the voluntary consent form. Patients who consent to participate in the registry will receive a signed and dated copy of the consent form. Informed consent must be obtained before any assessments are performed.