NCT05040854Unknown不适用
Can we Rely on HLA to Predict Resistance to Biological Therapy in IBD Patients
Centro Hospitalar Tondela-Viseu1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2021年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Response to biological therapy
研究概览
简要总结
The investigators propose an observational study including patients with inflammatory bowel disease under biological therapy with anti-TNF, anti-integrin α₄β₇ or anti-interleukin 12-23 (Ustekinumab), followed by an external Gastroenterology consultation at Centro Hospitalar Tondela-Viseu.
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
- 是
入选标准
- •Patients with the diagnosis of IBD (according to ECCO diagnosis criteria);
- •Adult patients (over 18 years);
- •Full capability of signing informed consent.
排除标准
- •Patients who refuse to participate in the study;
- •Patients submitted to prior biological therapy (only for the IBD-naive group)
结局指标
主要结局
Response to biological therapy
时间窗: 36 months
To assess whether the presence of the HLA-DQA1\*05 and HLA DRB1 alleles in patients with inflammatory bowel disease is associated with primary failure or loss of response to biological therapy with anti-TNF (Infliximab and Adalimumab), anti-integrin α₄β₇ (Vedolizumab) or anti-interleukin 12-23 (Ustekinumab).
次要结局
- Prevalence of HLA-DQ1*05 and DRB1(36 months)
研究者
Ana Carvalho
Principal Investigator
Centro Hospitalar Tondela-Viseu
研究点 (1)
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