Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06586710
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-02-20
Brief Title:
Interferon Pathway Activation in Monogenic and Nonmonogenic Forms of Pediatric SLE
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Interferon Pathway Activation in Monogenic and Non-monogenic Forms of Pediatric SLE With Renal Involvement Multicenter Observational Study of Biological Samples
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 nephritis is a pivotal manifestation of pediatric SLE and an important prognostic factor It is hypothesized that activation of the interferon pathway is more pronounced in monogenic forms in which the response to IFN-I represents the primary alteration and likely the main pathogenic mechanism
This finding may also be relevant in light of the availability of new drugs that selectively target the IFN-I pathway
Demonstration of IFN-I pathway activation could be used as a diagnostic algorithm in aggressive pediatric forms resistant to immunosuppressive therapy and represent a therapeutic target
This finding may also be relevant in light of the availability of new drugs that selectively target the IFN-I pathway
Demonstration of IFN-I pathway activation could be used as a diagnostic algorithm in aggressive pediatric forms resistant to immunosuppressive therapy and represent a therapeutic target
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None