Juvenile Idiopathic Arthritis (JIA)NCT07882667
Development of a Multidimensional Prediction Model for the Course and Outcome of Early-Onset Juvenile Idiopathic Arthritis (JIA)
An observational study of Juvenile Idiopathic Arthritis (JIA), run by Istituto Giannina Gaslini at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis (JIA)
- How many people
- 130 participants
- Where
- 2 sitesItaly
- Study dates
- 30 Jul 2024to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients followed in Italian centres specialised in Paediatric Rheumatic Diseases.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
IRCCS Istituto Giannina Gaslini
Genova
Alessandro Consolaro, MD, PhD, +39 01056362729, alessandroconsolaro@gaslini.org
- Recruiting
Ospedale Vito Fazzi
Lecce
Adele Civino, MD, +39 0832 661479, studi.reumatologiaimmunologiapediatrica@asl.lecce.it
About this study
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:
- Quantification of disease activity through standardized clinical scores;
- Standardized ultrasound examination of 10 index joints;
- Ophthalmological examination with slit lamp and search for inflammatory cells in the anterior segment with optical coherence tomography(OCT);
- 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
- Conditions
- Juvenile Idiopathic Arthritis (JIA)
- Keywords
- predictive model, early onset JIA
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (2)
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.
Measured: 24 months
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start30 Jul 2024
- Primary completion30 Jul 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic Arthritis (JIA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Giannina Gaslini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882667
- Sponsor's protocol ID
- AURORA (id 13846)
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Multidimensional Prediction Model for the Course and Outcome of Early-Onset Juvenile Idiopathic Arthritis (JIA)
- ClinicalTrials.gov ID
- NCT07882667
- Acronym / sponsor ID
- AURORA (id 13846)
- Conditions
- Juvenile Idiopathic Arthritis (JIA)
- Keywords
- predictive model, early onset JIA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Istituto Giannina GasliniUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Evaluations will include:
- Quantification of disease activity through standardized clinical scores;
- Standardized ultrasound examination of 10 index joints;
- Ophthalmological examination with slit lamp and search for inflammatory cells in the anterior segment with optical coherence tomography(OCT);
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients followed in Italian centres specialised in Paediatric Rheumatic Diseases.
Key inclusion criteria (10 listed)
- For patients with JIA
- 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.
Key exclusion criteria (5 listed)
- For patients with JIA
- For control subjects
- ● Previous treatment with any synthetic or biologic DMARD before biologic sample collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Construction of an integrated multiparametric prediction model
Time frame: 24 months
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.
2 secondary outcomes
Evaluation of parameters for the prediction of polyarticular extension
Time frame: 24 months
Evaluation of parameters for the prediction of iridocyclitis
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Juvenile Idiopathic Arthritis (JIA), run by Istituto Giannina Gaslini at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Consolaro, MD, PhD (+39 01056362729, alessandroconsolaro@gaslini.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Construction of an integrated multiparametric prediction model (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.