EUCTR2008-008008-42-Outside-EU/EEA进行中（未招募）不适用
An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301E1
ovartis PharmaServices AG0 个研究点目标入组 200 人开始时间: 2012年3月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
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 from study CACZ885G2305 or CACZ885G2301 who achieved an adapted ACR pediatric 30 response 15 days after their initial dose of canakinumab but clinically deteriorated afterwards or a minimum ACR Pediatric 30 response was not maintained after Day 15 and intervention is deemed necessary by the investigator, or Patients in study CACZ885G2301 who are not eligible to enter Part II (withdrawal part) because they were not able to meet the corticosteroid entry criteria , or Responder patients in Part I or Part II who had not flared when CACZ885G2301 was stopped, or CACZ885G2301 patients who were responders in Part I but experienced a flare in
- •Treatment- naïve patients need to meet the following criteria:
- •? Confirmed diagnosis of systemic juvenile idiopathic arthritis as per ILAR definition that must have occurred at least 2 months prior to enrollment with onset of disease < 16 years of age
- •? Male and female patients aged = 2 to < 20 years of age
- •? Active disease at the time of enrollment defined as follows: At least 2 joints with active arthritis AND C-reactive protein (CRP) > 30 mg/L (normal range < 10 mg/L)
- •? Naïve to canakinumab
- •Other protocol-defined inclusion criteria may apply
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 190
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •History of allergy or hypersensitivity to study drug
- •With active or recurrent bacterial, fungal or viral infections at time of enrollment
- •Other protocol-defined exclusion criteria may apply
研究者
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