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

NCT06718049 | Not Yet Recruiting

• 1 other identifier: REUMAIL18/2020
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Systemic Juvenile Idiopathic Arthritis (sJIA)

Keywords

Systemic Juvenile Idiopathic Arthritis

Outcome Measures

Primary Outcomes (1)

• Serum levels of IL-18, and IL-18BP

  pg/mL

  at T0 - T1(3 months) - T2(12 months)

Secondary Outcomes (2)

• Serum levels of inflammatory cytokines

  at T0 - T1(3 months) - T2(12 months)

• Serum levels of acute phase proteins

  at T0 - T1(3 months) - T2(12 months)

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Patients in whom the suspicion of rheumatic disease is based on a finding of subclinical carditis or chorea.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample for haematochemical analysis and assay of IL-18 and IL-18BP

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Angela Miniaci, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela Miniaci, MD

CONTACT

00390512144811; angela.miniaci@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 5, 2024
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 12, 2026

Record last verified: 2025-11

Locations

IT (1)