Clinical, Laboratory and Ultrasound Stratification of Patients With Juvenile Idiopathic Arthritis

Clinical, Laboratory and Ultrasound Stratification of Patients With Juvenile Idiopathic Arthritis and Outcomes Evaluation During Transition to Adult Care

Juvenile Idiopathic Arthritis (JIA), the most common rheumatologic chronic disease in children, is defined as arthritis persisting for at least 6 weeks with no known cause in a patient under the age of 16. The term JIA is an umbrella that includes very different diseases. The current International League of Associations for Rheumatology (ILAR) classification divides JIA patients into 7 categories based on number of involved joints and time of involvement, presence of systemic symptoms, psoriatic findings and spondyloarthritis. This classification groups together patients with different disease and divides patients with the same disease. In the first case, unifying distinct diseases could lead to undifferentiated therapeutic choices, moving away from the modern concept of therapeutic personalization. In the second case, similarities between paediatric and adult arthritis could not be found. This involves both a loss of collaboration with the adult rheumatologist and the difficulty in accessing possibly effective therapies approved only for adult arthritis.

In clinical practice, it is increasingly evident that the number of affected joints and the speed of joint involvement are not useful criteria for defining the type and severity of disease. Joint counts lead to underestimate the importance of joint distribution in the identification of distinct forms of arthritis. A recent study found that patterns of joint involvement represent prognostic features, so grouping patients by joint pattern and degree of localization may help clinicians tailor treatments based on predicted disease trajectories. Another important point to differentiate some forms of arthritis is the presence of enthesitis and tenosynovitis. Sometimes tendon inflammation can be not clinically evident, so ultrasound evaluation is useful to detect it. Musculoskeletal ultrasound (MSUS) has been used worldwide by adult rheumatologist, but it is beginning a useful tool also in patients with JIA. Recent studies underline the important role of MSUS findings to assess disease activity and assist disease classification. In recent years, the need has emerged to replace the ILAR criteria with a new nomenclature based on the disease biology. This approach could help clinicians to choose a personalized therapeutic strategy for patients with arthritis.

Study Overview

• Status: Recruiting
• Conditions: Juvenile Idiopathic Arthritis

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Serena Pastore, MD; Phone Number: +390403785477; Email: serena.pastore@burlo.trieste.it

Study Locations

• Italy
  • Trieste, Italy, 34137
    • Recruiting
    • IRCCS Burlo Garofolo
    • Contact: Serena Pastore, MD; Phone Number: +390403785477; Email: serena.pastore@burlo.trieste.it
  • Udine, Italy
    • Recruiting
    • (Department of Medical and Biological Sciences, Rheumatology Clinic, University of Udine
    • Contact: Alen Zabotti; Email: alen.zabotti@asufc.sanita.fvg.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects with JIA during the transition to adult care

Description

Inclusion Criteria:

• Subjects under the age of 18 years
• Arthritis persisting for at least 6 weeks with no known cause

Exclusion Criteria:

• No consent from the patients' guardians
• Patients with Systemic onset Juvenile Idiopathic Arthritis
• Patients who developed arthritis on a pre-existing inflammatory disorder such as Inflammatory Bowel Disease, and had received previous treatments

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients at onset of juvenile arthritis; New diagnosis of JIA
Patients with juvenile arthritis in follow up; Subjects with JIA already followed at Rheumatologic Service

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate disease activity by the Juvenile Arthritis Disease score during the transition to adult care	The Juvenile Arthritis Disease score (JADAS) includes 4 measures: physician's global assessment of disease activity, measured on a 0-10 visual analog scale (VAS) (0=no activity-10=maximum activity); parent global assessment of well-being, measured on a 0-10 VAS (0=very well-10=very poor); the erythrocyte sedimentation rate, normalized to a 0 to 10 scale; and a count of joints with active disease. The final score is calculated as the sum of the scores of these four components (higher scores indicate higher disease activity).	Between 14-17 years of age
To evaluate disease activity by the Health Assessment Questionnaire - Disability Index during the transition to adult care	The Health Assessment Questionnaire - Disability Index (HAQ-DI) includes 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities, with 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section. The 8 scores of the 8 sections are summed and divided by 8.	Between 14-17 years of age
To assess joint damage by radiological examination during the transition to adult care	Radiographs will be performed to assess the presence of joint damage	Between 14-17 years of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate non-inflammatory pain by the widespread pain index scale during transition to adult care	Pain will be evaluated through the widespread pain index (WPI) scale that assesses the presence of pain in 19 designated body locations over the past 7 days. Each location is equal to a score of 1. The WPI indicates the total number of areas that are painful, giving a maximum value of 19. WPI score can range from 0 to 19.	Between 14-17 years of age

Collaborators and Investigators

• Sponsor: IRCCS Burlo Garofolo
• Investigators: Study Director: Serena Pastore, MD, IRCCS Materno Infantile Burlo Garofolo

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Estimated): September 15, 2024
• Study Completion (Estimated): March 15, 2026

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: August 22, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: JIA; classification; transition of care
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Juvenile
• Other Study ID Numbers: RC 23/22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No