Systemic Juvenile Idiopathic Arthritis (sJIA)NCT06718049
Role of Interleukin 18 (IL-18) and Interleukin 18 Binding Protein (IL-18BP) in the Diagnostic Work-up of Systemic Juvenile Idiopathic Arthritis and Autoinflammatory Diseases: Possible Biomarkers in the Differential Diagnosis of Other Febrile Diseases
An observational study of Systemic Juvenile Idiopathic Arthritis (sJIA), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Literature data suggest that elevated blood values of IL-18 and IL-18 Binding Protein and alterations in their ratio may be significantly correlated with various autoinflammatory diseases, such as systemic juvenile idiopathic arthritis, recurrent autoinflammatory fevers etc. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Systemic Juvenile Idiopathic Arthritis (sJIA)
- How many people
- 9 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2027to 31 Dec 2027
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study enrolls patients referred to the Pediatric Rheumatology Outpatient Clinic of the Pediatrics Unit, IRCCS Azienda Ospedaliero-Universitaria of Bologna, Italy, for suspected Juvenile Idiopathic Arthritis or suspected recurrent fever/self-inflammatory disease.
Who may be able to join
- Age between 2 years and 18 years;
- Being affected by 1 of the following: Juvenile Idiopathic Arthritis; recurrent fever/ autoinflammatory disease; rheumatic disease; severe infectious diseases (sepsis, meningitis, urinary tract infection, lower respiratory tract infection);
- Obtaining informed consent from parents/legal guardians of paediatric patients.
Who cannot join
- Patients in whom the suspicion of rheumatic disease is based on a finding of subclinical carditis or chorea.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Angela Miniaci, MD, 00390512144811, angela.miniaci@aosp.bo.it
Angela Miniaci
About this study
Literature data suggest that elevated blood values of IL-18 and IL-18 Binding Protein and alterations in their ratio may be significantly correlated with various autoinflammatory diseases, such as systemic juvenile idiopathic arthritis, recurrent autoinflammatory fevers etc. In this view, the clinical implication of this observational, prospective, single-centre, non-pharmacological study will be the definition of new laboratory markers that may be useful in the early differential diagnosis of certain rare and serious paediatric diseases.
Read the detailed description
The primary aim of this study is to investigate the role of IL-18 and IL-18 Binding Protein as biomarkers of systemic Juvenile Idiopathic Arthritis and recurrent autoinflammatory fevers, while the secondary one is to investigate the superiority of IL-18 and IL-18 Binding Protein over other cytokines and inflammatory indexes in the differential diagnosis of systemic Juvenile Idiopathic Arthritis and recurrent fevers of an autoinflammatory nature.
The study will enroll patients referred to the Pediatric Rheumatology Outpatient Clinic of the Pediatrics Unit, IRCCS Azienda Ospedaliero-Universitaria of Bologna, Italy, for suspected Juvenile Idiopathic Arthritis or suspected recurrent fever/self-inflammatory disease.
Patients will be enrolled during the acute phase of the disease and, prior to the start of immunosuppressive therapy (i.e. corticosteroids, colchicine, biological drugs), a blood sample will be taken for haematochemical investigations, according to clinical practice, as well as an additional blood sample for the assay of IL-18 and IL-18 Binding Protein.
The following variables will be considered for each patient: demographic data; key clinical features; haemochromocytometric test; liver and kidney function tests; indexes of inflammation and acute phase proteins; inflammatory cytokines panel; serum values of IL-18 and IL-18 Binding Protein.
- Keywords
- Systemic Juvenile Idiopathic Arthritis
- Medical subject headings
- Arthritis, Juvenile
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum levels of IL-18, and IL-18BP
pg/mL
Measured: at T0 - T1(3 months) - T2(12 months)
Secondary outcomes (2)
Serum levels of inflammatory cytokines
IL-6; IL-8; TNF alpha; IL-12p70; IL-1 beta; IL-10 (pg/mL)
Measured: at T0 - T1(3 months) - T2(12 months)
Serum levels of acute phase proteins
C-reactive protein (mg/dL); amyloid A protein (mg/dL); ferritin (ng/dL); transferrin (mg/dL); fibrinogen (mg/dL)
Measured: at T0 - T1(3 months) - T2(12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Juvenile Idiopathic Arthritis (sJIA)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
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Miniaci, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Angela Miniaci, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718049
- Sponsor's protocol ID
- REUMAIL18/2020
- Status last verified
- Nov 2025
- First submitted
- 1 Dec 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Interleukin 18 (IL-18) and Interleukin 18 Binding Protein (IL-18BP) in the Diagnostic Work-up of Systemic Juvenile Idiopathic Arthritis and Autoinflammatory Diseases: Possible Biomarkers in the Differential Diagnosis of Other Febrile Diseases
- ClinicalTrials.gov ID
- NCT06718049
- Acronym / sponsor ID
- REUMAIL18/2020
- Keywords
- Systemic Juvenile Idiopathic Arthritis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Dec 2024 (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.
Literature data suggest that elevated blood values of IL-18 and IL-18 Binding Protein and alterations in their ratio may be significantly correlated with various autoinflammatory diseases, such as systemic juvenile idiopathic arthritis, recurrent autoinflammatory fevers etc. In this view, the clinical implication of this observational, prospective, single-centre, non-pharmacological study will be the definition of new laboratory markers that may be useful in the early differential diagnosis of certain rare and serious paediatric diseases.
Detailed description
The primary aim of this study is to investigate the role of IL-18 and IL-18 Binding Protein as biomarkers of systemic Juvenile Idiopathic Arthritis and recurrent autoinflammatory fevers, while the secondary one is to investigate the superiority of IL-18 and IL-18 Binding Protein over other cytokines and inflammatory indexes in the differential diagnosis of systemic Juvenile Idiopathic Arthritis and recurrent fevers of an autoinflammatory nature.
The study will enroll patients referred to the Pediatric Rheumatology Outpatient Clinic of the Pediatrics Unit, IRCCS Azienda Ospedaliero-Universitaria of Bologna, Italy, for suspected Juvenile Idiopathic Arthritis or suspected recurrent fever/self-inflammatory disease.
Patients will be enrolled during the acute phase of the disease and, prior to the start of immunosuppressive therapy (i.e. corticosteroids, colchicine, biological drugs), a blood sample will be taken for haematochemical investigations, according to clinical practice, as well as an additional blood sample for the assay of IL-18 and IL-18 Binding Protein.
The following variables will be considered for each patient: demographic data; key clinical features; haemochromocytometric test; liver and kidney function tests; indexes of inflammation and acute phase proteins; inflammatory cytokines panel; serum values of IL-18 and IL-18 Binding Protein.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study enrolls patients referred to the Pediatric Rheumatology Outpatient Clinic of the Pediatrics Unit, IRCCS Azienda Ospedaliero-Universitaria of Bologna, Italy, for suspected Juvenile Idiopathic Arthritis or suspected recurrent fever/self-inflammatory disease.
Key inclusion criteria (3 listed)
- Age between 2 years and 18 years;
- Being affected by 1 of the following: Juvenile Idiopathic Arthritis; recurrent fever/ autoinflammatory disease; rheumatic disease; severe infectious diseases (sepsis, meningitis, urinary tract infection, lower respiratory tract infection);
- Obtaining informed consent from parents/legal guardians of paediatric patients.
Key exclusion criteria (1 listed)
- Patients in whom the suspicion of rheumatic disease is based on a finding of subclinical carditis or chorea.
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
Serum levels of IL-18, and IL-18BP
Time frame: at T0 - T1(3 months) - T2(12 months)
pg/mL
2 secondary outcomes
Serum levels of inflammatory cytokines
Time frame: at T0 - T1(3 months) - T2(12 months)
Serum levels of acute phase proteins
Time frame: at T0 - T1(3 months) - T2(12 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 12 Mar 2026.
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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.
Angela Miniaci, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Juvenile Idiopathic Arthritis (sJIA), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site 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 3 inclusion and 1 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: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Angela Miniaci, MD (00390512144811, angela.miniaci@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum levels of IL-18, and IL-18BP (time frame: at T0 - T1(3 months) - T2(12 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 12 Mar 2026.