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Clinical Trial 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).


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03728478
Study type Interventional
Source Istituto Giannina Gaslini
Contact Alessandro Consolaro, MD, PhD
Phone 01056362729
Email alessandroconsolaro@gaslini.org
Status Recruiting
Phase Phase 3
Start date May 29, 2019
Completion date February 28, 2024