EUCTR2019-003068-39-NL进行中（未招募）1 期
Withdrawal of Infliximab in patients with inflammatory bowel disease in remission guided by pharmacokinetics: WINK study - WINK study
MC Utrecht0 个研究点目标入组 30 人开始时间: 2019年11月4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
- 30
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
- •Age > 18 years Diagnosis of IBD (Crohn’s Disease, Ulcerative colitis, IBD-U) Use of IFX with at >1 remaining dose scheduled after informed consent Clinical remission >6 months without IBD-related use of corticosteroids. Undetectable trough level of IFX (last available measurement) Endoscopic remission (SESCD<5 or eMayo<3) confirmed within 1 year prior to inclusion (exception possible, see protocol) Informed consent
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Planned step-up therapy
研究者
相似试验
已完成
不适用
Withdrawal of INfliximab in patients with inflammatory bowel disease in remission guided by pharmacoKinetics: WINK study.Inflammatory bowel disease Ulcerative Colitis Crohn's Disease10017969NL-OMON49879niversitair Medisch Centrum Utrecht50
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