跳至主要内容
临床试验/NCT02134054
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

Helse Stavanger HF1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2014年4月最近更新:
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

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

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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