EUCTR2013-002562-39-NL进行中（未招募）不适用
An exploratory, open-label, single centre, phase II, proof of concept study of gevokizumab treatment in patients with Schnitzler syndrome.
Institut de Recherches Internationales Servier (IRIS)0 个研究点开始时间: 2013年7月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •- Male or female, aged = 18 years
- •- Weight = 45 kg and = 125 kg
- •- For subjects with reproductive potential, a willingness to use highly effective contraceptive measures, and for female subjects a negative serum pregnancy test
- •- Probable or definite Schnitzler syndrome according to Strasbourg criteria.
- •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 2
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •- Differential diagnoses other than Schnitzler syndrome,
- •- Any prior treatment with systemic alkylating agents within the previous 6 months prior to selection,
- •- Active TB disease,
- •- History of severe allergic or anaphylactic reactions to monoclonal antibodies,
- •- History of malignancy within 5 years prior to selection,
- •- Known immunodeficiency,
- •- Infectious disease,
- •- Any live (attenuated) vaccine within 3 months prior to selection,
- •- Pregnancy, breastfeeding or possibility to become pregnant during the study
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