Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04891640
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2021-05-14
Brief Title:
Biologic Abatement and Capturing Kids Outcomes and Flare Frequency in Juvenile Spondyloarthritis
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
Biologic Abatement and Capturing Kids Outcomes and Flare Frequency in Juvenile Spondyloarthritis BACK-OFF JSpA
Status:
RECRUITING
Status Verified Date:
2024-08
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:
BACK-OFF JSpA
Brief Summary:
This randomized pragmatic trial will generate knowledge about strategies used to de-escalate tumor necrosis factor inhibitor TNFi therapy in patients with juvenile spondyloarthritis with sustained inactive disease and are treated at one of the 29 participating pediatric healthcare systems This open label study will be conducted in the setting of routine clinical care and will compare the risk and timing of flare Aim 1 and patients lived experiences Aim 2 across three arms
Detailed Description:
This project is a prospective 12-month pragmatic randomized trial embedded within routine clinical care Children with spondyloarthritis who have maintained inactive disease on a clinically prescribed standard dosing of a TNFi for 6 months or longer will be eligible for enrollment Children will be randomized to one of the following alternative approaches continued fixed standard dosing arm 1 fixed longer dosing intervals of TNFi arm 2 or stopping TNFi arm 3 The recommended visit frequency is every 3 months through the study endpoint at 12 months After subjects have followed their treatment assignment for 12 months those who have not flared may modify their treatment regimen as per shared decision making between themselves and the treating physician All participants will be monitored for 24 additional months for long-term outcomes after the intervention period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GRT-00001036 | OTHER_GRANT | PCORI | None |