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Efficacy and safety of guselkumab in biologic-na\u00efve patients with active axial psoriatic arthritis: study protocol for STAR a phase 4 randomized double-blinded placebo-controlled trial. 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Access to study data was limited to CorEvitas; CorEvitas statisticians completed all analyses, and all authors contributed to the interpretation of the results. CorEvitas has been supported through contracted subscriptions in the last 2 years by AbbVie, Amgen, Arena, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Chugai, Eli Lilly and Company, Genentech, Gilead, GlaxoSmithKline, Janssen, LEO, Novartis, Ortho Dermatologics, Pfizer Inc., Regeneron, Sanofi, Sun, and UCB.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"Philip J. Mease reports research support, consulting fees, and\/or speaker bureau support from AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Galapagos, Gilead, GlaxoSmithKline, Janssen, Lilly, Novartis, Pfizer, SUN Pharma, and UCB. Alexis Ogdie reports consultant fees from AbbVie, Amgen, Bristol Myers Squibb, Celgene, CorEvitas, Gilead, Global Health Living Foundation, Janssen, Lilly, Novartis, Pfizer, and UCB and has received grants to the University of Pennsylvania from AbbVie, Pfizer, and Novartis and to Forward from Amgen. Dr. Ogdie\u2019s spouse has received royalties from Novartis. Soumya D. Chakravarty and Iris Lin are employees of Janssen Scientific Affairs, LLC, and shareholders in Johnson & Johnson, of which Janssen Scientific Affairs, LLC is a wholly owned subsidiary. Natalie J. Shiff is an employee of Janssen Scientific Affairs, LLC, a wholly owned subsidiary of Johnson & Johnson,\u00a0and owns stock in Johnson & Johnson,\u00a0AbbVie, and Gilead. Robert R. McLean and\u00a0Wendi Malley are employees of CorEvitas, LLC. Rebecca L. Spitzer was employed by CorEvitas, LLC when the work was conducted.\u00a0Arthur Kavanaugh reports consulting fees from AbbVie, Amgen, Bristol Myers Squibb, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, and UCB. Joseph Merola reports consultant and\/or investigator fees from AbbVie, Arena, Biogen, Bristol Myers Squibb, Dermavant, Janssen, Lilly, Novartis, Pfizer, Sun Pharma, and UCB.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The study was performed following Good Pharmacoepidemiology Practice. All participating investigators were required to obtain full board approval for conducting noninterventional research involving human subjects with a limited dataset. Sponsor approval and continuing review were obtained through a central institutional review board, the New England Independent Review Board (no. 120160610). For academic investigative sites that did not receive a waiver to use the central institutional review board, full board approval was obtained from the respective governing institutional review boards and documentation of approval was submitted to CorEvitas, LLC prior to the initiation of any study procedures. All patients in the registry were required to provide written informed consent and authorization prior to participating.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"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.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"All the results presented in the article are in aggregate form and no personal identifiable information was used for this study.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Data are available from CorEvitas, LLC through a commercial subscription agreement and are not publicly available. No additional data are available from the authors.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"Conceptualization: SDC, IL, RRM, WM, and RLS; data curation: RRM, WM, and RLS; analysis and interpretation of data: PJM, AO, SDC, IL, RRM, WM, RLS, AK, and JM; writing, original draft: SDC, NJS, IL, LC; writing, review and editing: all authors. All authors have read and approved the final version of the manuscript.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}