Predicting the course of early-onset juvenile idiopathic arthritis using a multidimensional model
Official title: Development of a Multidimensional Prediction Model for the Course and Outcome of Early-Onset Juvenile Idiopathic Arthritis (JIA)
Run by Istituto Giannina Gaslini · NCT07882667 · Data updated 2026-11-12
Researchers are testing a comprehensive model to predict how early-onset JIA will progress in affected children and how a small control group with iridocyclitis compares.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 2 Years to 17 Years |
| Sex | All |
| Enrollment | 130 (estimated) |
| Sponsor | Istituto Giannina Gaslini Academic / other |
| Locations | 2 sites (Genova and 1 other locations) |
| Status | Recruiting |
| Started | July 30, 2024 |
| Main results expected | July 30, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT07882667 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children diagnosed with JIA per ILAR criteria, onset within 6 months, and age at onset under 6 years, plus a control group of kids with non-JIA iridocyclitis up to age 17.
✕Probably not a fit
Patients whose JIA does not follow predictable patterns or whose data do not contribute to model development may not receive direct benefits.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational, multicenter study enrolling at least 100 children with early-onset JIA and 30 control patients with iridocyclitis not related to JIA. Participants will be assessed at baseline and at 3, 6, 12, 18, and 24 months using clinical disease activity scores, ultrasound of 10 joints, ophthalmologic exams, and various biospecimen analyses. The study will perform multiomic profiling, immune characterization, and extracellular-vesicle analyses to identify predictors of disease course and outcome. Data from family members may undergo whole-exome sequencing to explore genetic predispositions. The design is translational and no-profit, aligning observational data with potential biomarker discovery.
Why it matters
Potential benefit: If successful, the model could help clinicians forecast disease trajectories and tailor treatment plans for children with early-onset JIA.
How similar studies have gone: Previous research in pediatric rheumatic diseases has shown that multiomic and immunophenotyping approaches can reveal predictive markers, though this exact model is a novel integration for early-onset JIA.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * For patients with JIA * A diagnosis of JIA according to the ILAR criteria by the treating pediatric rheumatologist * Classification in one of the following ILAR JIA categories: oJIA, RF-pJIA, PsA, or undifferentiated arthritis * Age \< 6 years at onset * Onset of JIA symptoms no more than 6 months before enrolment * Duly executed, written, informed consent/assent obtained from the parents/patient. For control subjects * A diagnosis of Iridocyclitis not correlated to JIA by the treating pediatric ophtalmologist * Age ≤ 17 years at diagnosis * Duly executed, written, informed consent/assent obtained from the parents/patient. Exclusion Criteria: * For patients with JIA * Classification in one of the following ILAR JIA categories: systemic arthritis, RF-positive polyarthritis, enthesitis-related arthritis * Previous treatment with any synthetic or biologic DMARD before biologic sample collection. For control subjects ● Previous treatment with any synthetic or biologic DMARD before biologic sample collection.
Where it's running
-
IRCCS Istituto Giannina Gaslini
Genova, Italy Recruiting -
Ospedale Vito Fazzi
Lecce, Italy Recruiting
Study contacts
- Study coordinator: Alessandro Consolaro, MD, PhD
- Email: alessandroconsolaro@gaslini.org
- Phone: +39 01056362729
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.