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临床试验/EUCTR2011-005145-12-GR
EUCTR2011-005145-12-GR进行中(未招募)不适用

A DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED CLINICAL TRIAL OF THE SAFETY AND EFFICACY OF ANAKINRA IN PATIENTS WITH HIDRADENITIS SUPPURATIVA (PROTOCOL: HIDRA03) - ANAKINRA IN HIDRADENITIS SUPPURATIVA

niversity of Athens, Medical School0 个研究点开始时间: 2011年11月21日最近更新:
适应症
相关药物

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

  • written informed consent provided by the patient;
  • age above 18 years;
  • diagnosis of HS; and
  • HS of Hurley II or III stage disease
  • 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 18
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 2

排除标准

  • history of systemic lupus erythematosus, of rheumatoid arthritis of of seronegative inflammatory arthritis;
  • any prior administration of any type of anti-TNF therapy over the last six months;
  • administration of any live (attenuated) vaccine over the last 4 weeks;
  • history of recurrent vein thrombosis or embolism compatible with anti-cardiolipin syndrome;
  • any present or smoldering infection;
  • hepatic dysfunction defined as any value of transaminases, of ?-glutamyl transpeptidase or of bilirubin> 2 x upper normal limit;
  • history of haematological or solid tumor malignancy, arterial hypertension, liver cirrhosis, HIV infection, and hepatitis virus B or C infection
  • history of episodes mimicking demyelinating disorders or a definite diagnosis of multiple sclerosis
  • any creatinine value above 1.5 mg/dl
  • intake of corticosteroids defined as daily intake of prednisone or equivalent more than 1mg/kg for the last three weeks;
  • neutropenia defined as <1000 neutrophils/mm3; and
  • pregnancy or lactation

研究者

发起方
niversity of Athens, Medical School

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