Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06431750
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-04-30
Brief Title:
Prospective Observational Study to Evaluate Secukinumab Treatment Effectiveness in Pediatric Patients With Active Juvenile Enthesitis-related or Psoriatic Arthritis
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Prospective Observational Study to Evaluate Secukinumab Treatment Effectiveness in Pediatric Patients With Active Juvenile Enthesitis-related or Psoriatic Arthritis Toddler
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Toddler
Brief Summary:
This is a multicenter non-interventional cohort study in pediatric patients with active juvenile enthesitis-related or psoriatic arthritis
Detailed Description:
Rheumatologists and pediatricians actively managing pediatric Enthesitis-related Arthritis ERA and Juvenile Psoriatic Arthritis jPsA in different regions of Russia are planned to participate in the study To be include in this study physicians must consult more than 10 pediatric patients with ERAjPsA in a typical month Any pediatric patients with active ERAjPsA who started secukinumab treatment index date within 4-8 weeks prior to inclusion can be enrolled At the inclusion retrospective data collection is planned then data will be collected 3 months of treatment 6 12 18 and 24 months after index date Therefore maximum duration of prospective observation is expected to be 23 months Data collection schedule fits routine Juvenile Idiopathic Arthritis JIA management guidelines for patients receiving biologics stating that treatment effectiveness should be evaluated at 3 and 6 months after biologic initiation and every 6 months thereafter At each visit effectiveness and tolerability parameters as well as the patients Quality of life QoL will be documented Retrospective data will be collected for medical history and JIA treatment including secukinumab before inclusion as well to describe all necessary parameters since the Index date Expected look-back period is 12 months
Initiation of secukinumab treatment will be considered the index date
Initiation of secukinumab treatment will be considered the index date
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