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RecruitingNCT07882667Updated Oct 20, 2026

Development of a Multidimensional Prediction Model for the Course and Outcome of Early-Onset Juvenile Idiopathic Arthritis (JIA)

An observational study in Juvenile Idiopathic Arthritis (JIA), sponsored by Istituto Giannina Gaslini. Recruiting at 2 sites in Italy. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Istituto Giannina Gaslini · Observational

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 2 months later.
Updated Oct 20, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
130
Ages
2 Years to 17 Years
Sex
All
01

Study summary

This is a prospective-retrospective, translational, no profit, multicentric, observational study. A cohort of at least 100 early-onset JIA patients attending the Unit of Rheumatology and Autoinflammatory Diseases, Department of Pediatric Sciences, IRCCS Istituto Giannina Gaslini or selected Italian pediatric rheumatology centers, will be enrolled and evaluated at onset and at 5 time points of follow up to 24 months (month 3, month 6, month 12, month 18 and month 24) to monitor the course of the disease. A cohort of 30 patients with Iridocyclitis not correlated to JIA will be recruited in parallel at the time of disease diagnosis as a group of control for comparison.

Read the detailed description

Evaluations will include:

  1. Quantification of disease activity through standardized clinical scores;
  2. Standardized ultrasound examination of 10 index joints;
  3. Ophthalmological examination with slit lamp and search for inflammatory cells in the anterior segment with optical coherence tomography(OCT);
  4. Collection of blood, urine, tears, and, in the case of joint infiltration, synovial fluid (SF) samples for carrying out the following analyses:

    • Evaluation of routine hematologic laboratory parameters and known markers of disease activity
    • Whole exome sequencing (WGS) on patients and families to identify any predisposing genetic factors
    • Multiomic analyses (proteomic, metabolomic, and lipidomic)
    • Immunological characterization: leukocyte subset imunophenotyping, cytokine/chemokine profiling, NETosis quantification
    • Extracellular-vesicle analysis: miRNomic, proteomic, and phenotypic characterization
02

Conditions studied

  • Juvenile Idiopathic Arthritis (JIA)

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Keywords

  • predictive model
  • early onset JIA
03

In context

Arthritis, Juvenile

359 studies on the registry are indexed under Arthritis, Juvenile; 95 are open to participants now.

This study's planned enrollment of 130 is close to the median of 120 across 115 observational studies indexed under Arthritis, Juvenile.

Browse Arthritis, Juvenile studies →

Lead sponsor

Istituto Giannina Gaslini is the lead sponsor of 50 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pediatric patients followed in Italian centres specialised in Paediatric Rheumatic Diseases.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
130 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Early-onset JIA patients

    Early-onset Juvenile Idiopathic Arthritis (JIA) represents the most common form of arthritis in Western country, affecting the 70-80% of Italian children. It typically occurs before the age of 6, has female predilection, high frequency of positive antinuclear antibodies (ANA),and is characterized by a high risk (20-30% of cases) of chronic iridocyclitis

  • Iridocyclitis patients not correlated to JIA

    Group of control for comparison.

06

What researchers measure

Primary outcomes

  1. Construction of an integrated multiparametric prediction model

    In the 1st phase, data will be pre-processed to make them suitable to be analyzed by machine learning techniques (harmonized, filtered, imputed, and mapped). In the 2nd phase the most suitable machine learning approach will be designed. Model design will involve the selection of a suitable supervised learning approach such as multivariate time-series forecasting, and the identification of technical solutions to manage dataset sparseness, model overfitting, and class unbalancing. In the 3rd phase, the machine learning model will be implemented using open-source languages such as Python. Programming code will be tested in virtualized environment using synthetic and\\or real data collected in the previous phases of the project. In the 4th phase, the storage and computational resources will be acquired and set up to be employed. In the 5th phase, parts of the dataset will be randomly split in two groups. One group will be used to train the machine learning model and the second for testing.

    Time frame: 24 months

Secondary outcomes

  1. Evaluation of parameters for the prediction of polyarticular extension

    To evaluate the predictive ability of a wide range of clinical, ultrasound, genetic, multiomic, and immunological parameters for the prediction of polyarticular extension in patients with early-onset JIA.

    Time frame: 24 months

  2. Evaluation of parameters for the prediction of iridocyclitis

    To evaluate the predictive ability and specificity of clinical, ultrasound, genetic, multiomic, and immunological parameters for the prediction of iridocyclitis development in patients with early-onset JIA.

    Time frame: 24 months

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2024 (actual). Primary completion is estimated for Jul 2028, 48 months after the start.

Of 41 observational studies under Arthritis, Juvenile, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 186. This study's planned 48 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 12, 2026
First posted
Oct 20, 2026
StartActual
Jul 30, 2024
Primary completionEst.
Jul 30, 2028
CompletionEst.
Dec 31, 2028
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07882667
Lead sponsor
Istituto Giannina Gaslini
Responsible party
Sponsor
First posted
Oct 20, 2026
Start date
Jul 30, 2024
Primary completion
Jul 30, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Oct 20, 2026

Study contacts

Alessandro Consolaro, MD, PhD
Contact
alessandroconsolaro@gaslini.org
+39 01056362729

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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