Lindgren, Luise Holberg https://orcid.org/0000-0002-9393-4405
Thomsen, Tanja https://orcid.org/0000-0002-7112-2318
Hetland, Merete Lund https://orcid.org/0000-0003-4229-6818
Aadahl, Mette https://orcid.org/0000-0001-5904-9747
de Thurah, Annette https://orcid.org/0000-0003-0103-4328
Christensen, Robin https://orcid.org/0000-0002-6600-0631
Esbensen, Bente Appel https://orcid.org/0000-0001-5331-8221
Funding for this research was provided by:
Novo Nordisk Fonden (0096696)
Lundbeck Foundation (Not yet recieved)
Gigtforeningen (R251-A9062)
Copenhagen University
Article History
Received: 19 December 2024
Accepted: 5 October 2025
First Online: 27 November 2025
Declarations
:
: The trial was approved by the Regional Committee on Health Research Ethics for the Capital Region of Denmark nr H-24046135. Furthermore, the RCT was approved by the Danish Data Protection Agency of the Capital Region of Denmark (Nr.: p-2024-15846) and was registered at ClinicalTrials.gov. nr.: NCT06533423. All data will be treated confidentially and in accordance with EU legislation and data security regulations, and legislation (GDPR). The principles of the Declaration of Helsinki will be followed. We will secure informed consent from participants. The trial sponsor and the project manager will ensure that all information collected during the study will be kept confidential in accordance with Danish Data Protection Agency rules.This trial protocol has been prepared as outlined in the PREPARE guide [ ], and reported according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist [ ].All potential patients will receive oral and written information about the trial. Participation is voluntary, and participants can at any time and without justification leave the trial without affecting their rheumatological treatment. The participants will give the primary investigator and project manager permission to obtain data from the patients’ journals in the informed consent. Informed consent material is available in Danish.
: The informed consent form is available from the corresponding author on request.
: The authors declare that they have no competing interests.