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临床试验/NCT04205734
NCT04205734暂停不适用

Methotrexate Polyglutamate Measurements in Patients With Inflammatory Bowel Disease

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
100
试验地点
1
主要终点
Methotrexate Polyglutamate Level

研究概览

简要总结

There are currently no serum levels to help guide appropriate methotrexate therapy. Data from this study will assess the correlation between dosing and whole blood methotrexate(MTX) polyglutamate measurements in children and adolescents with IBD.

详细描述

This is a cross-sectional study design. Subjects will be requested to provide one blood sample to be collected during the conduct of their routine clinical care. Data related to the diagnosis and interval assessment of enrolled subjects will also be collected.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
1 Year 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Methotrexate Therapy

排除标准

  • Inability to provide relevant samples

结局指标

主要结局

Methotrexate Polyglutamate Level

时间窗: Samples will collected within 16 weeks of consent.

Measurement of Methotrexate Polyglutamate Levels

次要结局

  • The correlation between Methotrexate Polyglutamate Levels and Clinical History(Samples will collected within 16 weeks of consent.)
  • The correlation between Methotrexate Polyglutamate Levels and Lab Parameters(Samples will collected within 16 weeks of consent.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Web

Assistant Professor of Pediatrics

Boston Children's Hospital

研究点 (1)

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