NL-OMON40729撤回4 期
Trough level-based dose reduction during infliximab maintenance treatment in Crohn*s disease - REDIX
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 54
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •-Diagnosis of CD based on endoscopy and pathology
- •-18 years or older
- •-At least 6 months in remission, defined as:
- •---Harvey Bradshaw Index *4,
- •---Normal serum C-reactive protein (CRP) level (<5 mg/l), and
- •---Low fecal calprotectin level (< 250 ug/g)
- •-IFX therapy >6 months at 5 mg/kg every 8 weeks with or without concomitant immunosuppression (stable for > 3 months).
- •-IFX TL > 7 ug/ml.
排除标准
- •-Non-adherence to the 8 weekly infusions schedule in the past
- •-Participation in another therapeutic trial
- •-Prior dose adjustments or interval shortening of IFX
研究者
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