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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-18
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Serum levels of IL-18, and IL-18BP

pg/mL

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

Secondary outcomes

1

Serum levels of inflammatory cytokines

IL-6; IL-8; TNF alpha; IL-12p70; IL-1 beta; IL-10 (pg/mL)

Time frame
at T0 - T1(3 months) - T2(12 months)
2

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)

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

Other outcomes

Sponsors and contacts

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