NL-OMON37989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) - HiTS (Hidradenitis suppurativa Treatment with Stelara)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patient above 18 to 65 years old
- •Patient with hidradenitis suppurativa Hurley stage II-III
- •Failure on conventional therapy with topical and oral antibiotics or immunosuppresiva or surgical intervention or on previous TNF alpha therapy (is not obligatory)
- •Patient has to be able to fill in a dutch formulated questionnaire
- •Signed informed consent
- •Women of childbaring age should use contraception
排除标准
- •Patients unable to fill in the questionnaires (mentally or physically)
- •Pregnancy or breast feeding patients
- •Patients with an active (chronic) infection, e.g. hepatitis B or C, HIV, tuberculosis
- •History of malignancy in past 10 years, except a basal cell carcinoma
- •Patients with demyelinating disease
- •Heartfailure NYHA class III-IV
- •Patients with a known allergy/hypersensitivity reaction to ustekinumab or one of the preservatives
- •Vaccination with living virus/bacterium < 3 months before starting ustekinumab
- •Severe liver or kidney dysfunction > 1.5 times of the maximum allowable value
研究者
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