NCT02134054进行中(未招募)不适用
Stavanger University Hospital IBD Study - a Cross Sectional Longitudinal Study on Patients Treated With Biologics
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Clinical remission rate
研究概览
简要总结
In this cross sectional and longitudinal study, patients with inflammatory bowel disease on biological treatment with infliximab or adalimumab will be included.
After inclusion, the dosage of their existing biological therapy will be adjusted following regular trough-level and antibody-level monitoring, according to a treatment algorithm.
Disease activity markers, fatigue and QoL will be assessed during the study. The hypothesis is that therapeutic drug monitoring may improve clinical disease outcome after one year of follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with inflammatory bowel disease on treatment with infliximab or adalimumab of any duration (at least 3 doses)
排除标准
- •Inability to consent
- •Inability to adhere to treatment protocol.
结局指标
主要结局
Clinical remission rate
时间窗: One Year
Harvey Bradshaw Index \<5 Partial Mayo score \<=2
次要结局
- Inflammatory markers(One year)
- Symptom scoring(One Year)
- Fatigue scoring(One Year)
研究者
研究点 (1)
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