Funding for this research was provided by:
Stichting Vermeer 14 (not applicable)
WM de Hoop Stichting (not applicable)
Reade (not applicable)
Reade Foundation (not applicable)
Received: 12 June 2021
Accepted: 4 October 2021
First Online: 18 October 2021
: The study protocol was approved by the Medical Ethical Committee of the Amsterdam University Medical Center, location VUmc, on April 26 2019 with protocol identification number NL66649.048.18. The trial was prospectively registered in the Netherlands Trial Register (ExternalRef removed) with identification numbers NL7800, NL7801, and NL7802 for the RA, MSOA, and APCA-positive arthralgia trials respectively. The trial registry includes all items from the World Health Organization Trial Registration Set and keeps an audit trail. All participants give written informed consent (including consent for collection and use of participant data) to the involved researchers or research associate. Subjects are informed about data storing and handling and are guaranteed on the discrete handling of their data (including pseudonymisation of body materials).The trial was classified as “low-risk” by the Medical Ethical Committee and does not involve ancillary and post-trial care or compensation for any harm from those who suffer from trial participation. Medical care as needed will be supplied to the subject who discontinues the study. For subjects who discontinue the study due to the occurrence of adverse events potentially related to the intervention, follow-up will take place until the adverse event has abated, or until a stable situation has been reached, with findings being recorded in CASTOR (the digital case report form). However, given the nature of the intervention, this is not expected.Due to the low risk level of this study monitoring is not mandatory. To ensure quality of this study, monitoring of source data handling will be performed locally. The monitoring will follow and check the standard operating procedure (SOP) of the Amsterdam University Medical Centers.Serious adverse events need to be reported till end of study within the Netherlands. The investigator will report all serious adverse events to the sponsor without undue delay after obtaining knowledge of the events. All other adverse events will be followed until they have abated, or until a stable situation has been reached. Depending on the event, follow-up may require additional tests or medical procedures as indicated and/or referral to the general physician or a medical specialist.Patients can discontinue participation at any time. The general practitioner of the patient receives information on participation of the patient during start of the program. Patients will decide with their physician whether discontinuation is necessary. Subjects can leave the study at any time for any reason if they wish to do so without any consequences. The investigator can decide to withdraw a subject from the study for urgent medical reasons.The investigator/sponsor will notify the accredited ethical medical committee of the (premature) end of the study or of a temporary halt (including the reason) within a period of 8 weeks. Within 1 year after the end of the study, the investigator/sponsor will submit a final study report with the results of the study, including any publications/abstracts of the study, to the accredited ethical medical committee.
: The authors declare no competing interests.