跳至主要内容
临床试验/EUCTR2011-003478-98-GR
EUCTR2011-003478-98-GR进行中(未招募)1 期

A Phase 3 Open-Label Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Hidradenitis Suppurativa.

Abbott GmbH & Co. KG0 个研究点目标入组 600 人开始时间: 2012年5月11日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
600

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

  • 1. Subjects who previously participated in a prior Phase 3 Abbott HS study and:
  • Completed the study; or
  • Experienced a loss of response (LOR); or
  • Experienced Worsening or Absence of Improvement
  • 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 450
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 150

排除标准

  • 1. Prior treatment with any other anti-TNF therapy (e.g., infliximab, etanercept), or participation in an adalimumab trial other than a prior Phase 3 Abbott HS study.
  • 2. Subject received any oral antibiotic treatment for HS within 28 days prior to the Baseline visit, except for antibiotics permitted in a prior Phase 3 Abbott HS study.
  • 3. Subject received oral concomitant analgesics (including opioids) for HS-related pain within 14 days prior to the Baseline visit, except for permitted analgesics taken in the prior Phase 3 Abbott HS study.

研究者

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