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
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
- 否
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
