跳至主要内容
临床试验/NCT05071404
NCT05071404已完成不适用

Efficacy Assessment and Monitoring of Subcutaneous Infliximab Levels in Patients With Inflammatory Bowel Disease.

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
1
主要终点
Perform an efficacy assessment and monitoring of subcutaneous infliximab levels in patients with inflammatory bowel disease.

研究概览

简要总结

Retrospective observational study in which the efficacy of infliximab is studied in patients with inflammatory bowel disease and its subcutaneous levels are monitored.

详细描述

Retrospective observational study in which the efficacy of infliximab is studied in patients with inflammatory bowel disease and its subcutaneous levels are monitored.

Treatment is prior to and independent of the patient's participation in the study and is governed by clinical judgment criteria and routine clinical practice, not performing any diagnostic or follow-up intervention that is not routine clinical practice.

Patients are older than 14 years who suffer from inflammatory bowel disease and who receive remsima as routine treatment.

The source of information will be the patient's medical history.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with inflammatory bowel disease.
  • Over 14 years old.
  • Receive Remsin as a treatment for his disease. And always this treatment that the patient is going to receive is governed by the criteria of clinical judgment and routine clinical practice, not performing any diagnostic or follow-up intervention that is not routine clinical practice.

排除标准

  • Patients with inflammatory bowel disease under 14 years of age.
  • Or older than this age with inflammatory bowel disease who do not attend the established check-ups

结局指标

主要结局

Perform an efficacy assessment and monitoring of subcutaneous infliximab levels in patients with inflammatory bowel disease.

时间窗: Up to 16 weeks.

Number of hospitalizations of patients treated with subcutaneous infliximab suffering from inflammatory bowel disease.

次要结局

未报告次要终点

研究者

研究点 (1)

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