Articular Damage in Patients With Juvenile Idiopathic Arthritis After Transition to Adult Care

NCT06895278 | Not Yet Recruiting

• 2 other identifiers: RC 35/241709
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

Juvenile idiopathic arthritis (JIA) is the most common childhood chronic rheumatic disease, encompassing all forms of arthritis that persist for more than 6 weeks, with onset before age 16, after exclusion of other causes of arthritis. It is a heterogeneous disease, whose complexity is only partially encompassed by the actual classification criteria and it is characterized by prolonged synovial inflammation that can lead to joint destruction. Whilst the assessment of structural joint damage is part of the routinary evaluation of disease severity and progression in patients with rheumatoid arthritis (RA), to the extent that it is considered a key end-point outcome in treatment efficacy studies, this is not the same for JIA. Some recommendations have been elaborated based on expert opinion, but only recently they have been translated into clinical practice. Such a discrepancy in approaching chronic arthritis has been for many years due to the lack of articular damage radiographic scoring system validated for pediatric age. Actually, joint space narrowing, bone erosions and demineralization, which is typical of adult articular damage, are not the same changes observed in pediatric population where early growth plate closure, epiphyseal deformity and growth asymmetries can be the major signs. The transition process from the pediatric to the adult health care team is a critical moment in the clinical history of patients with JIA, often hampered by the absence of specific criteria for the assessment of disease activity, the lack of specific treatment recommendations for JIA adult patients, the poor adolescent-specific training for adult rheumatologists, and the lack of communication between pediatric and adult centers. Adult patients with JIA have their own specific identity and should not be inappropriately re-categorized as having RA, ankylosing spondylitis or another condition once transitioned to the adult rheumatologist. The aim of this study is to quantify the articular damage of adult patient with JIA after closure of growth plates. This represent a sort of starting burden carried by the patients who receive transition to the adult rheumatologist care and which should be minimized in order to reduce long-term complications. Furthermore, the study aims to analyze possible correlations between the presence of articular damage, therapies taken in pediatric age, and characteristics of JIA at the onset and during the clinical course of the disease

Conditions

Juvenile Chronic Arthritis

Keywords

Juvenile idiopathic arthritis; JIA; transition to adult; articular damage

Outcome Measures

Primary Outcomes (2)

• Mean difference between groups in the radiographic Sharp/Van der Heijde score

  Radiological examinations of small joints (hands/wrists) will be pseudo-anonymized and centralized to a blinded radiologist to evaluate damage using the Sharp/Van der Heijde score, evaluating joint space narrowing and erosion with a range from 0 to 4 and from 0 to 5, respectively. The total Sharp/van der Heijde score is calculated as the sum of the scores for joint space narrowing (range 0-120) and erosion (range 0-160) and ranges from 0 to 280.

  At transition from pediatric to adult care, on average at the age of 18

• Mean difference between groups in the radiographic Larsen score

  Radiological examinations of knees and hips will be pseudo-anonymized and centralized to a blinded radiologist to evaluate damage using the Larsen score. The grading scale ranges from 0 to 5 (0=intact bony outlines and normal joint space, 5=mutilating changes). The Larsen score ranges from 0 to 120.

  At transition from pediatric to adult care, on average at the age of 18

Secondary Outcomes (2)

• Associations between the radiographic Sharp/Van der Heijde score and clinical characteristics

  At transition from pediatric to adult care, on average at the age of 18

• Associations between the radiographic Larsen score and clinical characteristics

  At transition from pediatric to adult care, on average at the age of 18

Study Arms (2)

Methotrexate group

Patients who underwent transition from pediatric to adult rheumatology care who spent most of their disease time on methotrexate therapy

Drug: Methotrexate

Biologic therapy group

Patients who underwent transition from pediatric to adult rheumatology care who spent most of their disease time on biologic therapy

Drug: Biological Drug

Interventions

Methotrexate DRUG

Prevalent use of methotrexate in pediatric age

Methotrexate group

Biological Drug DRUG

Prevalent use of biological drugs in pediatric age

Biologic therapy group

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All patients with Juvenile Idiopathic Arthritis who started transition process from a pediatric to an adult rheumatology center in the last 10 years will be enrolled

You may qualify if:

• Patients aged between 16 to 25 years who received a diagnosis of JIA in pediatric age according to International League of Associations for Rheumatology criteria (2001) and who have begun the process of transition to adult care.
• Young adults undergoing healthcare transition process from the the pediatric to adult rheumatology since 2016.
• Patients with radiological evidence of joint plates closure.
• X-ray images of hands, hips, and knees available

You may not qualify if:

• Patients cared at the adult rheumatology clinic who received a diagnosis of arthritis in the adult age.
• Patients with other orthopedic conditions or affected by other diseases leading to osteoporosis or skeletal deformities.
• Patients affected by other rheumatological conditions who underwent healthcare transition process from the the pediatric to adult rheumatology center.

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (3)

Azienda sanitaria di Reggio Emilia - Arcispedale Santa Maria Nuova

Reggio Emilia, Italia, 42122, Italy

Location

IRCCS Materno Infantile "Burlo Garofolo"

Trieste, Italia, 34100, Italy

Location

Istituto Azienda sanitaria universitaria Friuli Occidentale - Ospedale "Santa Maria della Misericordia"

Udine, Italia, 33100, Italy

Location

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

Methotrexate; Biological Products

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Complex Mixtures

Central Study Contacts

Serena Pastore, Pediatric rheumatologist

CONTACT

0039-040-3785-477; serena.pastore@burlo.trieste.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 26, 2025
• Study Start: April 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: December 31, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)