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

Concept

This multicenter, international longitudinal study will recruit JIA patients (according to ILAR classification criteria) with active disease according to JADAS 10 and 27 scoring prior starting recommended treatment. All JIA relevant data (demographics, duration, disease activity, medication usage and treatment efficacy) will be collected and parent/guardian written consent obtained. At enrolment and during predefined scheduled follow up visits (at 3 months up to 12 months) all JIA patients will be clinically evaluated by JADAS 10 and 27 scoring, examined by ultrasound gray-scale (GS) and Power Doppler (PD) in (44 joints) using OMERACT synovitis scoring system by an expert in pediatric ultrasound. At each visit blood samples will be obtained for evaluation of inflammatory markers (such as cytokines, chemokines and S100A8, S100A9 and S100A12). In the case of disease worsening, the same parameters will be performed as unscheduled visit.

Facts and figures

Project lead
D Lazarevic
Clinic of Pediatrics
lazarevic.gaga@gmail.com
FOREUM research grant: € 125,000
2019–2022

Meet the team

D Lazarevic
Clinic of Pediatrics
J Vojinovic
Pediatric Rheumatology Department
C Malattia
Istituto Giannina Gaslini
S Lanni
Milano Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
S Magni Manzoni
Roma Ospedale Pediatrico Bambino Gesu
L Rossi
CeRéMAIA, Bicêtre (Hôpital Bicêtre AP-HP)
B Sözeri
Umraniye Education and Research Hospital
T Herlin
Aarhus University
E Tsitsami
Aghia Sophia Children’s Hospital
D Windschall
St. Josef-Stift Sendenhorst

Objectives

  • 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

Patient voice

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.

Interim results

  • 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 / in preparation Italy (Milano), Denmark and Germany
  • 20 patients recruited (12 Servia, 3 Italy, 2 France, 3 Turkey)

Goals/Milestones

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