Ignite Creation Date:
2024-05-06 @ 12:18 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03728478
Status:
RECRUITING
Last Update Posted:
2022-05-13
First Post:
2018-10-31
Brief Title:
STep-up and Step-down Therapeutic Strategies in Childhood ARthritiS
Sponsor:
Istituto Giannina Gaslini
Organization:
Istituto Giannina Gaslini
Study Overview
Official Title:
Comparison of STep-up and Step-down Therapeutic Strategies in Childhood ARthritiS
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
RECRUITING
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:
STARS
Brief Summary:
This study aims to compare the effectiveness of a conventional therapeutic regimen based on treatment escalation step-up strategy and driven by the treat-to-target approach with that of an early aggressive intervention based on the initial start of a combination of conventional and biological DMARDs step-down strategy
Detailed Description:
Although their approach is different both interventions are aimed to obtain a quick and robust disease control and to maintain it over time Compelling evidence exists that in children with chronic arthritis early intensive therapy may take advantage of the so-called window of opportunity in which the biology of the disease can be altered to improve long-term disease outcomes including prevention of cumulative joint damage Recent experiences in children with systemic JIA have shown that early anti-IL-1 therapy may lead to rapid achievement of inactive disease and allow early treatment discontinuation without disease relapses in many patients The benefits of early treatment with biologic agents in other JIA categories are less clear but convincing evidence has been recently reported for polyarthritis
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?:
False
Is an FDA AA801 Violation?:
None