跳至主要内容
临床试验/EUCTR2015-000696-27-NL
EUCTR2015-000696-27-NL进行中(未招募)1 期

Anakinra versus treatment as usual in the treatment of acute gout - ATTACG

prof. dr. M.A.F.J. van de Laar0 个研究点目标入组 200 人开始时间: 2015年6月12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)
发起方
入组人数
200

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

入选标准

  • At least 18 years of age
  • Signed written informed consent
  • Identification of intracellular monosodium urate crystals in primary joint through aspiration of joint
  • 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 100
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 100

排除标准

  • Absolute contra-indication for urate lowering therapy
  • Absolute contra-indication for anakinra
  • Presence of liver disease that according to the treating physician precludes participation in the study
  • Absolute contra-indication for all three possible standard of care treatments (colchicine, naproxen, prednisolon)
  • Known history of allergy or sensitivity to latex
  • Current use of any ULT
  • Concurrent use of other IL-1 agents
  • Patient reports no to mild gout related pain
  • Pregnancy or lactation
  • Women who are planning on becoming pregnant within the study period (12 months)
  • Patients with active or recurrent bacterial, fungal or viral infection
  • Patients using tumor necrosis factor inhibitors
  • Patient has insufficient knowledge of the Dutch language for completing questionnaire independently

研究者

发起方
prof. dr. M.A.F.J. van de Laar

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