Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06895278

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

16 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda sanitaria di Reggio Emilia - Arcispedale Santa Maria Nuova, Reggio Emilia, Italia, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

methotrexate

Drug

Prevalent use of methotrexate in pediatric age

Biological Drug

Drug

Prevalent use of biological drugs in pediatric age

Primary outcomes

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

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

    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.

  2. Mean difference between groups in the radiographic Larsen score

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

    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.

Secondary outcomes

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

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

    The following variables will be included in multivariate analysis: age, age at onset, gender, family history of autoimmunity; clinical features of the disease during pediatric age (i.e., number and type of involved joints, JIA category according to 2001 International League of Associations for Rheumatology classification criteria, presence of enthesitis, tenosynovitis, psoriasis and uveitis in the patients' history); laboratory data (i.e., blood count, inflammation indexes, immunoglobulin levels, predisposing HLA, antinuclear antibodies, rheumatoid factor; disease activity score (JADAS-27 score) in the period closest to the radiography execution; therapies taken during the pediatric disease course.

  2. Associations between the radiographic Larsen score and clinical characteristics

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

    The following variables will be included in multivariate analysis: age, age at onset, gender, family history of autoimmunity; clinical features of the disease during pediatric age (i.e., number and type of involved joints, JIA category according to 2001 International League of Associations for Rheumatology classification criteria, presence of enthesitis, tenosynovitis, psoriasis and uveitis in the patients' history); laboratory data (i.e., blood count, inflammation indexes, immunoglobulin levels, predisposing HLA, antinuclear antibodies, rheumatoid factor; disease activity score (JADAS-27 score) in the period closest to the radiography execution; therapies taken during the pediatric disease course.

Study contacts

Contact information is provided by the study sponsor or research team.

Serena Pastore, Pediatric rheumatologist

CONTACT

[email protected]

0039-040-3785-477

Sponsors and collaborators

Lead sponsor

IRCCS Burlo Garofolo

Other

Registry information

Official study title

Evaluation of Articular Damage in Patients With Juvenile Idiopathic Arthritis (JIA) After Transition to Adult Care and Correlation With Disease Characteristics and Treatments.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 26, 2025
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.