NL-OMON47881招募中4 期
engthening Adalimumab Dosing Interval in quiescent Crohn*s disease patients: the LADI study. - Lengthening Adalimumab Dosing Interval in Crohn*s disease.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 174
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 or older
- •- Diagnosis of colonic and/or distal ileal CD
- •- Sustained steroid-free clinical remission for 9 months whilst being treated with adalimumab at a stable dose
- •- Adalimumab dosed at 40 mg every 2 weeks
- •- Full clinical response and disease control, all three criteria below need to be fulfilled prior to enrollment:
- •1. Absence of intestinal or extra-intestinal symptoms, as judged by both patient and physician
- •2. Fecal calprotectin (FC) lower than 150 µg/g and CRP <10 mg/L
- •- If endoscopic remission was recently confirmed, FC can be lower than 250 µg/g
- •3. Harvey Bradshaw Index (HBI) <5
排除标准
- •- Absence of written informed consent
- •- Concomitant corticosteroid usage
- •- Need for IBD-related surgery
- •- Actively draining peri-anal fistula
- •- Pregnancy or lactation
- •- Other significant medical conditions that might interfere with this study (such as current/recent malignancy, immunodeficiency syndromes and psychiatric illness)
- •- Impossibility to measure outcomes, e.g. planned relocation, language issues, short life expectancy
研究者
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