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临床试验/NCT02073526
NCT02073526已完成不适用

Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel Disease

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 1,230 人开始时间: 2013年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,230
试验地点
1
主要终点
Measurement of drug serum concentrations

研究概览

简要总结

Drug serum concentrations will be measured at several time-points for inflammatory disease patients treated with anti-TNF agents. The purpose is to determine which patients that will clinically benefit from either discontinue treatment, adjusting the dose, switch to another anti-TNF agent or a different class of medication.

详细描述

Crohn´s disease and ulcerative colitis are diseases where the proinflammatory cytokine Tumor Necrosis Factor-alpha (TNF) plays an important role. Anti-TNF agents are used in the treatment. However, some patients do not respond and response rates declines over time. The cause may be immunogenicity against the agent itself, the agent´s failure to neutralize TNF or another biological pathway leading to inflammation. Anti-TNF agents have been administrated as fixed doses at certain frequencies and this may not be optimal for all patients, but recent studies have indicated a correlation between efficacy and serum drug concentration levels (trough levels). Our preliminary data suggest that trough levels early in the treatment course may be predictive of later trough levels. By multiple measurements, this will be assessed. The study will also investigate biological markers in serum and blood cells which may be predictable for trough levels. Finally, we will compare different methods to measure serum drug concentrations.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with Inflammatory bowel disease
  • Treated with anti-TNF drug
  • Follow-up at specialized gastroenterologist in Norway
  • Age 18 or over

排除标准

  • Patients refusing to participate by not giving their informed consent

研究组 & 干预措施

Anti-TNF

Inflammatory bowel patients age 18 and over treated with anti-TNF agents

干预措施: Infliximab, adalimumab, certolizumab pegol (Drug)

结局指标

主要结局

Measurement of drug serum concentrations

时间窗: Serum samples will be collected on average 8 weeks (range 0-90 days) after drug administration

Drug serum concentration will be measured using an ELISA

次要结局

  • Change in individuals drug serum concentration(Serum samples will be collected on average 8 weeks (range 0-90 days) after drug administration)
  • Measure soluble TNF-receptor in serum(Measurement will be conducted in 2015 on blood samples stored in a bio-bank)
  • Assay validation(December 2013 - March 2014)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Knut E. A. Lundin

Professor

Oslo University Hospital

研究点 (1)

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