D5.1 / Study initiation package (iPROLEPSIS-PDPID study)

Psoriatic arthritis (PsA) is an immune mediated inflammatory arthritis occurring in patients with psoriasis. Patients with PsA experience difficulties in dealing with unpredictable disease activity which can affect their quality of life. Development of a digital biomarker using smart devices such as smartphone and smartwatch would allow for an unobtrusive remote monitoring of disease activity in these patients. Besides, understanding what factors trigger flare would allow for a better disease control. The iPROLEPSIS-PDPID study is a multicentre observational cohort study that aims to develop an unobtrusive and affordable digital biomarker capable of detecting changes in disease activity including flare in patients with PsA, and to identify triggers of flare in these patients. The study will be conducted in four countries (Netherlands, UK, Portugal and Greece) and will involve patients with PsA. Therefore, an ethical approval will be required from each country to be able to initiate the study in. Application of ethical approval requires submission of multiple documents, such as country specific forms, study protocol, patient information file and consent form, patient assessment tools, and information on participating centers and principal investigators. By the time of writing, of the participating countries, ethical approval has been granted to initiate the study in the Netherlands (Erasmus MC), UK (University of Oxford), Greece (Hipokrateion Hospital Thessaloniki), and Portugal (local site: Hospital de Santa Maria). The Erasmus MC is the sponsor of the study. The deliverable D5.1 is the initial deliverable for Task T5.1 and Task T5.2, which are part of work package (WP) 5. In this report, we provide the study registration number in Netherlands and the forms that were required to obtain the ethical approval. Besides, we provide information on the eCRF management system of the study. Data obtained from task T5.2 (iPROLEPSIS-PDPID study) will be analysed in WP3.