Routine Assessment of Patient Index Data 3 (RAPID3) in Patients with Rheumatoid Arthritis Treated with Long-Term Upadacitinib Therapy in Five Randomized Controlled Trials

Funding

AbbVie Inc. (North Chicago, IL, USA) funded this study and the journal’s Rapid Service Fee and Open-Access Fee, and participated in the study design, research, analysis, data collection, interpretation of data, review, and approval of the publication.

Medical Writing, Editorial, and Other Assistance

Medical writing support was provided by Dan Booth, PhD, on behalf of 2 the Nth (Cheshire, UK), and was funded by AbbVie.

Authorship

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Authorship Contributions

Martin Bergman, Maya H. Buch, Yoshiya Tanaka, Gustavo Citera, Sami Bahlas, Ernest Wong, Yanna Song, Patrick Zueger, Mira Ali, and Vibeke Strand were all involved in study conception and design, data collection, analysis and interpretation, drafting the manuscript and revising it for critically important intellectual content, and approving the final version.

Disclosures

Martin Bergman has received consulting fees from AbbVie, Amgen, GSK, Janssen, Novartis, Pfizer, Sanofi, and Scipher; speaking fees from AbbVie, Amgen, GSK, Novartis, and Sanofi; and is a shareholder of Johnson & Johnson and Merck. Maya H. Buch has received research grants from Pfizer, Roche, and UCB; and consulting fees from AbbVie, Eli Lilly, Merck Serono, Pfizer, Sandoz, and Sanofi. She is supported by the National Institute for Health Research (NIHR) Manchester Biomedical Research Centre, and has been awarded NIHR Senior Investigator Status. Yoshiya Tanaka declares speaking fees and/or honoraria from AbbVie, Asahi Kasei, Astellas, Bristol-Myers Squibb, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, GSK, Janssen, Mitsubishi Tanabe, Novartis, Pfizer, Sanofi, Takeda, UCB, and YL Biologics; and research grants from AbbVie, Astellas, Bristol-Myers Squibb, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi Tanabe, MSD, Ono, Taisho Toyama, and Takeda. Gustavo Citera has received consulting fees from AbbVie, Bristol-Myers Squibb, Eli Lilly, Genzyme, Pfizer, and Roche. Sami Bahlas declares no conflicts of interest. Ernest Wong has received research grants from AbbVie, Chugai, Novartis, and UCB; and consulting fees from AbbVie, Chugai, Eli Lilly, MSD, Novartis, Pfizer, Roche, and UCB. Yanna Song, Patrick Zueger, and Mira Ali are employees of AbbVie and may own stock or options. Vibeke Strand declares consulting fees from AbbVie, Amgen, Arena, AstraZeneca, Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Celltrion, Eli Lilly, Gilead, Ichnos, Inmedix, Janssen, Kiniksa, MSD, Novartis, Pfizer, Regeneron, Rheos, Samsung, Sandoz, Sanofi, Scipher, Setpoint, Spherix, and UCB.

Compliance with Ethics Guidelines

All SELECT trials were conducted according to the International Conference on Harmonization guidelines and the principles of the Declaration of Helsinki of 1964 and its later amendments. All patients provided written informed consent. The trial protocols were approved by the relevant independent ethics committees and institutional review boards of all participating institutions, and were sponsored by AbbVie. All authors have provided their approval for this version to be published. The study reports a post hoc analysis of data from five previously published clinical trials. Ethics approval was obtained for each of those trials, and is reported in the published papers.

Data Availability

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual, and trial-level data (analysis datasets), as well as other information (e.g., protocols and clinical study reports), provided the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. 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 https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html.

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