Treatment strategies for juvenile idiopathic arthritis patients with sustained inactive disease: A phase 4, multicentre, randomised trial comparing maintenance versus tapered TNF alpha inhibitor monotherapy - the Treat-JIA trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- The primary outcome of this study is the proportion of study participants with a disease flare* during the first 12 months follow-up compared between the TNFi withdrawal group and the stable treatment group. *Disease flare is defined as a combination of: A clinically significant increase in JIA Activity Score 27 (JADAS-27) ≥1.7 from baseline AND active joints ≥1 (swollen, or tender + limited range of motion) OR consensus between treating physician and participant/parents
研究概览
简要总结
To assess the effect of treatment withdrawal, compared to stable dose of tumor necrosis factor inhibitor (TNFi), on the risk of flares in children and adolescents with juvenile idiopathic arthritis with sustained inactive disease on TNFi monotherapy for 12 months follow-up*. *Sustained inactive disease is defined as clinically judged inactive disease for ≥12 months documented at a minimum of 2 consecutive visits AND inactive disease (JIA-ACR/Wallace criteria) at inclusion.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Fulfilment of the ILAR classification criteria for non-systemic JIA; 2 to <18 years of age at the time of signing the informed consent; clinically judged inactive disease for ≥12 months documented at a minimum of 2 consecutive visits; inactive disease (JIA-ACR/Wallace criteria) at inclusion; no active uveitis for ≥24 months; stable treatment with TNF-inhibitor monotherapy for ≥12months.
排除标准
- •Corticosteroid use (including intra-articular injections) at the indication of JIA less than 12 months prior to randomization; chronic widespread pain syndrome.
研究组 & 干预措施
Hyrimoz 40 mg solution for injection in pre-filled syringe, Hyrimoz 20 mg solution for injection in pre-filled syringe
干预措施: Hyrimoz 40 mg solution for injection in pre-filled syringe (Drug)
Hyrimoz 40 mg solution for injection in pre-filled syringe, Hyrimoz 20 mg solution for injection in pre-filled syringe
干预措施: Hyrimoz 20 mg solution for injection in pre-filled syringe (Drug)
Enbrel 25 mg solution for injection in pre-filled pen, Benepali 50 mg solution for injection in pre-filled pen
干预措施: Enbrel 25 mg solution for injection in pre-filled pen (Drug)
Enbrel 25 mg solution for injection in pre-filled pen, Benepali 50 mg solution for injection in pre-filled pen
干预措施: Benepali 50 mg solution for injection in pre-filled pen (Drug)
Simponi 50 mg solution for injection in pre-filled syringe.
干预措施: Simponi 50 mg solution for injection in pre-filled syringe. (Drug)
结局指标
主要结局
The primary outcome of this study is the proportion of study participants with a disease flare* during the first 12 months follow-up compared between the TNFi withdrawal group and the stable treatment group. *Disease flare is defined as a combination of: A clinically significant increase in JIA Activity Score 27 (JADAS-27) ≥1.7 from baseline AND active joints ≥1 (swollen, or tender + limited range of motion) OR consensus between treating physician and participant/parents
The primary outcome of this study is the proportion of study participants with a disease flare* during the first 12 months follow-up compared between the TNFi withdrawal group and the stable treatment group. *Disease flare is defined as a combination of: A clinically significant increase in JIA Activity Score 27 (JADAS-27) ≥1.7 from baseline AND active joints ≥1 (swollen, or tender + limited range of motion) OR consensus between treating physician and participant/parents
次要结局
- Time to flare and time to regain inactive disease after flaring up to 12 months
- Changes in validated measures of disease activity up to 12 months
- Reports of adverse events, serious adverse events, and suspected unexpected adverse reactions up to 12 months
研究者
Pernille Bøyesen
Scientific
Oslo Universitetssykehus HF