NCT01432249撤回不适用
Post Marketing Surveillance To Observe Safety And Efficacy Of Enbrel In Pediatric Patients With Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- Safety measured by discontinuation due to adverse events
研究概览
简要总结
Enbrel was first approved as new medicine on 06 Oct 2003 in Korea and the indication of Pediatric Psoriasis was approved on 23 Sep 2009. However, as required for any new indication approved by Korea Food and Drug Administration (KFDA), safety and efficacy information of new indication should be provided at minimum 600 subjects administered in the setting of routine practice during the initial 4 years after new indication approved.
详细描述
All patients enrolled should meet the usual prescribing criteria for Enbrel in psoriasis as per the local product information for usage.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents aged 8 years to 17 years at time of consent
- •Chronic severe psoriasis patients who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies
排除标准
- •Patients with known hypersensitivity to Enbrel or any component of the product
- •Patients with active infections including chronic or localized infections such as tuberculosis (Treatment of Enbrel should not be initiated)
研究组 & 干预措施
Enbrel
The patients who are prescribed Enbrel for pediatric psoriasis
干预措施: Enbrel group (Drug)
结局指标
主要结局
Safety measured by discontinuation due to adverse events
时间窗: 6 month
次要结局
- Proportion of subjects achieving a 50% and 75% improvement from baseline in PASI (Psoriasis Area-and-Severity Index) over 12 weeks and 24 weeks(6 month)
- Proportion of subjects achieving a status on the PGA (Physician's Global Assessment) of psoriasis of clear (0), clear/almost clear (0/1), or clear/almost clear/mild (0/1/2) at 12 weeks and 24 weeks(6 month)
研究者
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