van der Schoot, Lara S. https://orcid.org/0000-0002-4127-1187
van den Reek, Juul M. P. A.
Grine, Lynda
Schots, Lisa
Kievit, Wietske
Lambert, Jo L. W.
de Jong, Elke M. G. J.
Funding for this research was provided by:
Belgian Health Care Knowledge Center (BeNeFIT call 2018, BeNeBio study – 18562)
ZonMw (BeNeFIT call 2018, BeNeBio study – 18562)
Article History
Received: 4 February 2021
Accepted: 4 October 2021
First Online: 16 October 2021
Declarations
:
: The study will be performed in accordance with the applicable national laws and regulations (the current version of the World Medical Association’s Declaration of Helsinki (59th WMA General Assembly, Seoul, 2008), the guidelines and guidance documents specifying Good Clinical Practice (“GCP”) and guidelines of competent national authorities; all applicable laws, rules, and legislation in relation to clinical trials, data protection and the processing of personal data, and patient’s rights, including but not limited to the General Data Protection Regulation 2016/679 (“GDPR”), the Medical Research Involving Human Subjects Act (WMO) for the Netherlands, and the Belgian law relating to experiments in humans dated May 7, 2004). For the Netherlands, the Medical Ethical Committee (Arnhem-Nijmegen) (reference number NL71920.091.19), the competent authority (Central Committee on Research Involving Human Subjects), as well as all ethical bodies of each participating site, approved the study. In Belgium, the study was approved by the competent authorities (FAMHP) and the Ethics Committee of Ghent University Hospital and University Ghent after consulting the Ethics Committees of each participating Belgian site. The trial protocol was developed according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement. Written informed consent will be obtained from each participant. Participants should give their permission for reuse of their data and biological specimens within the written informed consent form.
: Not applicable.
: LSS carries out clinical trials for Almirall, Janssen, and Novartis. All funding is not personal but goes to the independent Research Fund of the Department of Dermatology of the Radboud University Medical Centre Nijmegen, The Netherlands.JMPAR carried out clinical trials for AbbVie, Celgene, and Janssen and has received speaking fees/attended advisory boards from AbbVie, Janssen, BMS, and Eli Lilly and reimbursement for attending a symposium from Janssen, Pfizer, Celgene, and AbbVie. All funding is not personal but goes to the independent research fund of the department of dermatology of Radboud University Medical Center Nijmegen, the Netherlands.LG has received speaker fee from AbbVie. All funding is not personal and goes to an independent research account of the department of dermatology of Ghent University Hospital, Ghent, Belgium.LS has no competing interests.WK has no competing interests.EMGJJ has received research grants for the independent research fund of the department of dermatology of the Radboud university medical center Nijmegen, the Netherlands, from AbbVie, Pfizer, Novartis, Janssen Pharmaceuticals, and LEO Pharma and has acted as consultant and/or paid speaker for and/or participated in research sponsored by companies that manufacture drugs used for the treatment of psoriasis including AbbVie, Janssen Pharmaceutica, Novartis, Eli Lilly, Celgene, Leo Pharma, UCB, and Almirall. All funding is not personal but goes to the independent research fund of the department of dermatology of Radboud University Medical Centre Nijmegen (Radboudumc), the Netherlands.JLWL has received research grants from and/or acted as consultant/speaker for and has acted as consultant for AbbVie, Almirall, Amgen, Argenx, Eli Lilly, Janssen-Cilag, LEO Pharma, Novartis, Pfizer, and UCB. All funding is not personal and goes to an independent research account of the department of dermatology of Ghent University Hospital, Ghent, Belgium.