EUCTR2010-024156-28-DE进行中（未招募）1 期
A multi-center, double-blind, placebo-controlled phase II study of the efficacy and safety of canakinumab in subjects with Schnitzler syndrome - ILESCH
Charité - University Hospital of Berlin0 个研究点目标入组 20 人开始时间: 2011年4月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
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
- •Adults (18 years or older)
- •Informed consent signed and dated
- •Able to read, understand and willing to sign the informed consent form and abide with study procedures
- •SchS diagnosis based on diagnostic criteria defined in Appendix
- •Patients with symptomatic SchS (as defined by the physician’s global assessment with a minimum score of 8 and CRP >ULN)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Concurrent/ongoing treatment with anakinra (Kineret®) or recent treatment within 48 hours prior to day 0
- •Concurrent/ongoing treatment with other biologics or recent treatment (less than 5 half lives)
- •Concurrent/ongoing treatment with immunosuppressives (e.g. cyclosporine, methotrexate, dapsone or others) within 4 weeks or 5 half lives prior to day 0, whichever is longer
- •Concurrent/ongoing treatment with high doses of systemic steroids (>20mg prednisolone equivalent)
- •Evidence of recurrent or latent systemic infection such as tuberculosis
- •Significant medical condition rendering the patient immunocompromised or not suitable for a clinical trial
- •Treatment with a live (attenuated) virus vaccine during three months prior to day 0 and for 3 months after end of study
研究者
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