EUCTR2008-005479-82-Outside-EU/EEA进行中（未招募）不适用
A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations
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
- 177
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
- •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.
- •-Arthritis in one or more joints with or preceded by fever of at least 2 weeks duration that is documented to be daily for at least 3 days with accompanying symptoms
- •Active disease at the time of enrollment defined as follows:
- •? At least 2 joints with active arthritis (using ACR definition of active joint)
- •? Documented spiking, intermittent fever (body temperature > 38oC) for at least 1 day during the screening period within 1 week before first study drug dose
- •? C-reactive protein > 30 mg/L (normal range < 10 mg/L)
- •No concomitant use of second line agents such as disease-modifying and/ or immunosuppressive drugs will be allowed with the exception of:
- •? Stable dose of methotrexate for at least 8 weeks prior to the screening visit, and/or folic/folinic acid per standard medical practice
- •? Stable dose of no more than one non-steroidal anti-inflammatory drug for at least 2 weeks prior to the screening visit
- •? Stable dose of steroid treatment < or = to 1.0 mg/kg/day in 1-2 doses per day of oral prednisone or equivalent
- •Other protocol-defined inclusion criteria may apply.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 171
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 6
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Diagnosis of active macrophage-activation syndrome (MAS) within the last 6 months
- •Risk factors for tuberculosis
- •Patients with active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of HIV infection, Hepatitis B and Hepatitis C infection
- •Other protocol-defined exclusion criteria may apply.
研究者
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