Comparison of STep-up and Step-down Therapeutic Strategies in Childhood ARthritiS
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Clinical remission on or off medication at 12 months
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment arm 2: Step-down
JIA patients treated with an early combined therapy
干预措施: Etanercept (Drug)
Treatment arm 2: Step-down
JIA patients treated with an early combined therapy
干预措施: Methotrexate (Drug)
Treatment arm 2: Step-down
JIA patients treated with an early combined therapy
干预措施: Intra-articular corticosteroid injections (Drug)
结局指标
主要结局
Clinical remission on or off medication at 12 months
时间窗: 12 months
The effectiveness of the two therapeutic strategies will be compared by assessing the frequency of clinical remission (CR) at 12 months. CR is defined as the persistence of the JADAS state of ID for at least 6 months.
次要结局
- Cumulative level of disease activity throughout the study period(12 months)
- Time spent on therapy(12 months)
- Rate of flares(12 months)
- Rate of uveitis onset(12 months)
- Inactive disease(12 months)
- Time to inactive disease as per JADAS/JIA ACR criteria(12 months)
- Time to JADAS/JIA ACR clinical remission(12 months)
- Time spent in JADAS/JIA ACR inactive disease(12 months)
研究者
Alessandro Consolaro
Principal Investigator
Istituto Giannina Gaslini