NL-OMON49879已完成不适用
Withdrawal of INfliximab in patients with inflammatory bowel disease in remission guided by pharmacoKinetics: WINK study. - WINK study
niversitair Medisch Centrum Utrecht0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
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), timeline and possible exceptions
- •specified in protocol.
- •- Informed consent
排除标准
- •- No indication for additional IFX infusion in same dose and at same dosing
- •interval as part of routine clinical practice.
- •- Concomitant use of systemic steroids, ustekinumab, vedolizumab or
- •jak-inhibitor (tofacitinib) at the time of IFX infusion with study
- •measurements.
研究者
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