NCT01704534已完成2 期
A Prospective Proof of Concept Study to Evaluate the Potential Efficacy of Ustekinumab in Patients With Moderate to Severe Hidradenitis Suppurativa (Acne Ectopica)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Sartorius score
研究概览
简要总结
The purpose of this study is to determine whether ustekinumab is effective in the treatment of moderate to severe hidradenitis suppurativa.
详细描述
An open label prospective study is performed to investigate the effectiveness and safety of ustekinumab in hidradenitis suppurativa. Twenty patients will be included. They will receive ustekinumab 45 or 90 mg on weeks 0-4-16-28. Patients will be followed up untill week 40.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Hidradenitis suppurativa Hurley stage II or III
- •No response to conventional local and oral antibiotics, or immunnesuppressive medication, or TNF-alpha inhibitors or surgery
- •The patient has to be able to complete a dutch questionnaire
- •Informed consent must be obtained
排除标准
- •Not able to complete a Dutch questionnaire
- •Pregnancy or breast feeding
- •Active hepatitis B or C infection, HIV or tuberculosis
- •Treatment with biologics or other immunosuppressive medicine in the previous 3 months
- •Malignancies in the last 10 years with the exception of basal cell carcinoma
- •Demyelinating disorders
- •Heart failure
- •Known allergy to ustekinumab or to its preservatives
- •Live vaccins in the next 3 months Sever liver or renal failure
研究组 & 干预措施
Ustekinumab
Experimental
Ustekinumab 45 mg or 90 mg (dependent on patient's weight) administered on weeks 0-4-16-28
干预措施: Ustekinumab (Drug)
结局指标
主要结局
Change in Sartorius score
时间窗: 76 weeks
Clinical response is defined as an improvement of the Sartorius score of at least 50%
次要结局
未报告次要终点
研究者
研究点 (1)
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