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临床试验/NCT03663400
NCT03663400已完成不适用

Identify Predictors That Distinguish Between Tofacitinib Responders and Non-responders Based on Genotype and Cellular and Molecular Profiles From Pinch Biopsies, Blood and Stool Samples

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2018年12月4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
47
试验地点
1
主要终点
GWAS analysis pretreatment

研究概览

简要总结

This is a prospective cohort study enrolling ulcerative colitis patients who initiate tofacitinib therapy. Investigators will collect clinical data, blood and stool samples prior to initiation of tofacitinib and, at minimum, monthly after the start of therapy. They will collect tissue from colonoscopies prior to initiation of therapy and within 6 months on therapy. Clinical characteristics and response to treatment will then be associated with genotype, blood immune profiles, stool microbiota, and cellular and molecular profiles of the biopsies to generate a treatment response model. Using predictors identified in our model, we will then attempt to validate the model and findings with the OCTAVE (Pfizer), SPARC (CCF), and RISK (CCF) data.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Total mayo score between 6 and 12
  • Endoscopic subscore of 2 or 3

排除标准

  • Recent use of antibiotic therapy (<4 weeks)
  • Current extreme diet (parenteral nutrition, specific carbohydrate diet).
  • Active infection or malignancy.
  • Significant underlying liver or renal disease.

结局指标

主要结局

GWAS analysis pretreatment

时间窗: 1 Day

GWAS analysis by Illumina BeadChip to generate comprehensive genotype data on all 50 patients.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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