Mease, Phillip J.
Liu, Clive
Siegel, Evan
Richmond, Heather
Wu, Meijing
Chen, Liang
Douglas, Kevin
Lockshin, Benjamin
Funding for this research was provided by:
AbbVie
Article History
First Online: 14 October 2019
Compliance with Ethical Standards
:
: AbbVie funded the LOOP study, contributed to its design, and participated in data collection, analysis, and interpretation of the data, and in writing, review, and approval of the publication.
: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. Access is provided to anonymized patient and trial-level data (analysis datasets) as well as other information (e.g., protocols and clinical study reports) from AbbVie-sponsored phase II–IV global interventional clinical trials conducted in patients (completed as of May 2004, for products and indications approved in either the USA or the EU) as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. Access to these clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data-sharing agreement. Data requests can be submitted at any time, and the data will be accessible for 12 months, with possible extensions considered. For more information on the process or to submit a request, visit the following link:ExternalRef removed.
: P.J. Mease has received research grants, consulting fees, and/or speaker’s fees from AbbVie, Amgen, Bristol-Myers Squib, Celgene, Galapagos, Genentech, Gilead, Janssen, Lilly, Novartis, Pfizer, Sun Pharma, and UCB. B. Lockshin has received research grants, consulting fees, and speaker’s fees from AbbVie, Janssen, Lilly, and Novartis; has received research grants from Celgene and Strata; and is on the board of directors for the National Psoriasis Foundation. C. Liu has served as a speaker, on an advisory board, and/or as an investigator for AbbVie, Celgene, Janssen, Lilly, Novartis, Ortho, Regeneron, and Sanofi. E. Siegel has received research grants and acted as a speaker for and/or received consulting fees from AbbVie, Amgen, Celgene, Janssen, Lilly, Sanofi, and UCB. H. Richmond has received a research grant from AbbVie. M. Wu, L. Chen, and K. Douglas are employees of AbbVie and may own stock/options.
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committees and with the Declaration of Helsinki. All patients provided written informed consent.