Investigating the interferon pathway in childhood lupus
Interferon Pathway Activation in Monogenic and Non-monogenic Forms of Pediatric SLE With Renal Involvement. Multicenter Observational Study of Biological Samples.
This study is testing how a specific immune pathway works in children with lupus to see if it can help doctors better diagnose and treat the disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 1 Month to 17 Years |
| Sex | All |
| Sponsor | Meyer Children's Hospital IRCCS Academic / other |
| Locations | 3 sites (Florence and 2 other locations) |
| Trial ID | NCT06586710 on ClinicalTrials.gov |
What this trial studies
This study focuses on pediatric systemic lupus erythematosus (SLE), particularly examining the role of the interferon type I (IFN-I) pathway in both monogenic and nonmonogenic forms of the disease. It aims to assess the activation of the IFN-I pathway in children with SLE, especially those with renal involvement, to understand its potential as a diagnostic and therapeutic target. The research will explore whether monogenic forms of SLE exhibit more pronounced interferon activation, which could inform treatment strategies and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include children diagnosed with systemic lupus erythematosus before the age of 18, particularly those showing renal involvement.
Not a fit: Patients whose renal disease onset occurred after the age of 18 or those with secondary SLE due to other conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and therapeutic approaches for children with severe forms of lupus.
How similar studies have performed: While the specific activation of the IFN-I pathway in pediatric SLE has not been extensively studied, similar approaches in adult SLE have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Florence and 2 other locations
- Meyer Children's Hospital IRCCS — Florence, Italy (Recruiting)
- IRCCS Gianna Gaslini — Genova, Italy (Recruiting)
- IRCCS Humanitas Research Hospital — Rozzano, Italy (Recruiting)
Study contacts
- Principal investigator: Carmela Errichiello — Meyer Children's Hospital IRCCS, Florence, Italy
- Study coordinator: Carmela Errichiello, MD
- Email: carmela.errichiello@meyer.it
- Phone: 055/5662563
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.