EUCTR2007-000872-18-CZ进行中（未招募）不适用
A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab, followed by a 3 year open label continuation of the study to examine the long term use of tocilizumab. - TENDER
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 108
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •patients aged 2 - 17 years of age;
- •systemic JIA with >= 6 months persistent activity;
- •presence of active disease (>=5 active joints, or >=2 active joints + fever + steroids);
- •inadequate clinical response to NSAIDs and corticosteroids due to toxicity or lack of efficacy.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •wheelchair bound or bed-ridden;
- •any other autoimmune, rheumatic disease or overlap syndrome other than sJIA;
- •intravenous long-acting corticosteroids or intra-articular corticosteroids within 4 weeks of baseline, or throughout study;
- •DMARDs (other than methotrexate);
- •previous treatment with tocilizumab.
研究者
相似试验
进行中（未招募）
不适用
A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumabSystemic Juvenile Idiopathic Arthritis (sJIA)MedDRA version: 9.1Level: LLTClassification code 10059176Term: Juvenile idiopathic arthritisEUCTR2007-000872-18-SEF. Hoffmann-La Roche Limited108
进行中（未招募）
1 期
The effect of tocilizumab in children who have arthritis which can include fever, rash, inflammation of the lungs or heart, or enlarged spleen, liver or lymph nodes.EUCTR2007-000872-18-GBF. Hoffmann-La Roche Ltd.112
进行中（未招募）
不适用
The effect of tocilizumab in children who have arthritis which can include fever, rash, inflammation of the lungs or heart, or enlarged spleen, liver or lymph nodes.Systemic Juvenile Idiopathic Arthritis (sJIA)MedDRA version: 14.0Level: LLTClassification code 10059176Term: Juvenile idiopathic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2007-000872-18-DEF. Hoffmann-La Roche Ltd.108
进行中（未招募）
不适用
A 12-week randomized, double blind, placebo-controlled, parallelgroup, 2-arm study to evaluate the efficacy and safety oftocilizumab in patients with active systemic juvenile idiopathicarthritis (sJIA); with a 92-week single arm open-label extensionto examine the long term use of tocilizumabEUCTR2007-000872-18-SKF. Hoffmann-La Roche Limited108
进行中（未招募）
1 期
A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab.Systemic Juvenile Idiopathic Arthritis (sJIA)MedDRA version: 9.1Level: LLTClassification code 10059176Term: Juvenile idiopathic arthritisEUCTR2007-000872-18-NOF. Hoffmann-La Roche Limited108