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
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