Interferon Pathway Activation in Monogenic and Nonmonogenic Forms of Pediatric SLE
Recruiting · NCT06586710 · Interventional (participants receive a specific treatment) · Lead sponsor: Meyer Children's Hospital IRCCS
View the official record on ClinicalTrials.gov →Interventions studied
Assessment activation of interferon pathway
What this trial is about
Pediatric SLE includes monogenic forms, some of which involve the interferon type I (IFN-I) pathway. The IFN-I pathway is renally active in adult SLE and correlates with the extent of renal damage. In pediatric SLE, and particularly in lupus nephritis, activation of the IFN-I pathway has never been studied, nor is it known whether monogenic forms underlie more pronounced interferon activation.
Who can take part
Age range
1 Month to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Diagnosis of SLE arising before the age of majority (until the age of 18 years) according to SLICC and/or EULAR criteria 2019;
- Clinical, laboratory and/or histologic evidence of renal involvement manifested before the age of 18 years;
- Signature of informed consent.
Exclusion criteria
- Onset of renal disease after the age of 18 years;
- SLE secondary to drugs or associated with other diseases such as systemic sclerosis, rheumatoid arthritis, Sjögren's syndrome, and other connectivities.
Where it is running
3 locations listed.
- Meyer Children's Hospital IRCCS - Florence, Italy
- IRCCS Gianna Gaslini - Genova, Italy
- IRCCS Humanitas Research Hospital - Rozzano, Italy