Applicability of standardized ultrasound examination to estimate disease activity in combination with JADAS and inflammation markers in JIA patients

• to establish minimal corset of representative joints to be assessed by clinical examination and ultrasound to be used as outcome tool in JIA
• to investigate if joint findings correlate with the panel of laboratory inflammation markers
• tо evaluate sensitivity and predictive value of the multi-biomarker panel (clinical examination of the joints, ultrasound and inflammatory biomarkers) in JIA patients
• to test if multi-biomarker panel could be applied in every day clinical practice to predict response to treatment and outcome tool in JIA
• to improve possibility to achieve optimized personalized tailored treatment

• Month 0-3: Ethics Committees Approval, ICF and CRF preparation, organization of web based ultrasound calibration exercise
• Month 0-12: Active enrolment of the patients (to be extended if necessary)
• Month 12-18: Longitudinal phase of the study and midterm analysis
• Month 18-24: Termination of the follow up phase
• Month 24-27: Shipment of the blood samples and analysis
• Month 27-36: Statistical analysis and publications

• Obtained Ethics Comittee approvals: home center (Niš, Serbia) and host center (Genoa, Italy) / participating centers: France, Greece, Turkey, Italy (Milano), Denmark, and Germany / Rome Italy still in process
• Prepared Daisy Study Webportal (built up PRINTO platform for data collection from the Pharmachild registry with study material of importance for investigators:
  1. Instructions for Ultrasonographers / Ultrasound Educative Modules / Pathological Ped MSUS Athlas / Test for Ultrasonographers
  2. Study Protocol
  3. Laboratory Instructions and Lab Kits
• ACTIVATED participating centers: FRANCE, TURKEY, GREECE, ITALY (Milano), DENMARK, GERMANY, LITHUANIA and CROATIA
• 101 RECRUITED PATIENTS: 31 from SERBIA (home center), 17 from ITALY (host center), 10 from FRANCE, 26 from TURKEY, 9 from LITHUANIA, 2 from ITALY (Milano), 1 from GREECE, 1 from DENMARK, 2 from GERMANY and 2 from CROATIA

• D. Lazarevic, J. Vojinovic, C. Malattia , L. Rossi-Semerano , B. Sozeri, M. Tsinti, et al. Internal consistency and interrater reliability in musculoskeletal ultrasound in children. Pediatric Rheumatology 2022, 20(Suppl 2):P204Proceedings of the 28th European Paediatric Rheumatology Congress (PReS 2022) : Prague, Czech Republic. 20-23 September 2022. Pediatr Rheumatol Online J. 2022 Sep 7;20(Suppl 2):75.
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• D. Lazarevic, C. Malattia, AI Rebollo-Gimenez L. Rossi-Semerano , B. Sozeri, M. Tsinti, et al. Aplicability of standardized ultrasound examination to estimate disease activity in combination with JADAS and inflammation markers in JIA patients – the DAISY study design (AB1431 EULAR 2023).

Patient participation from local patient organizations will be crucial to explore which questions of interest have the greatest impact on the patient disease outcomes and treatment response. Planned is to include patients organizations representatives from each participating center and give them possibility to ask all questions important for their future perspectives. Patients feedback will be used to create a brochure with all disease aspects that patients want to know. This will help JIA patients and their families to better understand disease course and treatment strategies. The project results will also be presented during World Arthritis day.  All of this information will  be available on patients organization website and will be shared via other available social media channels.