Status:

RECRUITING

Interferon Pathway Activation in Monogenic and Nonmonogenic Forms of Pediatric SLE

Lead Sponsor:

Meyer Children's Hospital IRCCS

Conditions:

Systemic Lupus Erythematosus of Childhood

Eligibility:

All Genders

1-17 years

Phase:

NA

Brief Summary

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...

Detailed Description

Pediatric systemic lupus erythematosus (SLE) (cSLE), compared with adult SLE, is characterized by a more severe phenotype, with more marked hematologic, neuropsychiatric, and renal changes. Lupus neph...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

June 7 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2025

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT06586710

Start Date

June 7 2023

End Date

December 31 2025

Last Update

September 19 2024

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Meyer Children's Hospital IRCCS

Florence, Italy

2

IRCCS Gianna Gaslini

Genova, Italy

3

IRCCS Humanitas Research Hospital

Rozzano, Italy