EUCTR2007-000872-18-IT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 - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ROCHE
- 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
- •1. Age 2 up to and including 17 years at screening into trial; 2. Systemic Juvenile Idiopathic Arthritis according to ILAR classification (2001); 3. More than 6 months of persistent sJIA activity prior to screening including an inadequate response to NSAIDs and corticosteroids due to toxicity or lack of efficacy. 4. Presence of active disease as determined by the presence of : > 5 active joints, or > 2 active joints and fever >38C for at least 5 out of any 14 consecutive days during screening and receiving prednisone or equivalent at a stable dose at nomore than 0.5 mg/kg/day or 30 mg/day, whichever is less. During this same time period the corticosteroid dose continues unchanged. 5. hsCRP > 4.3 mg/L or 0.43 mg/dl (1.5 x ULN (ULN= 0.28 mg/dl)); 6. Recovered from any symptomatic serositis for at least one month prior to the screening visit, and requiring dose of corticosteroids < than 30 mg/day at baseline 7. Fertility: Female not of child-bearing potential, or Female of child-bearing potential practicing effective contraceptive measures, having a negative urine pregnancy test within three weeks prior to randomization; or Sterile male, or Non sterile male practicing effective contraceptive measures with female partner of child-bearing potential. [Females of childbearing potential must be using a reliable means of contraception (abstinence being a possible option) throughout the study and up to 12 weeks after the last infusion of study drug]. Etc.
- •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
- •General Exclusion Criteria 1. Wheelchair or bedridden; 2. Any other auto-immune, rheumatic disease or overlap syndrome other than sJIA; 3. Not fully recovered from recent surgery or less than six weeks since surgery, at the time of screening visit; or planned surgery during the initial 12 weeks of the study; 4. Lack of peripheral venous access; Other Exclusion criteria regarding - General Safety - Previous or Concomitant Therapy - Laboratory Exclusions
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