Determination of Ustekinumab Levels in Patients With Crohn's Disease: Use in Clinical Practice
试验速览
- 阶段
- 不适用
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Determine breakpoints.
研究概览
简要总结
Observational, prospective, single-center follow-up study carried out with patients from the area of the Virgen de Macarena University Hospital, diagnosed with chronic kidney disease, who started treatment with ustekinumab.
详细描述
Prospective follow-up observational study carried out with patients from the Virgen de Macarena University Hospital, under treatment with ustekinumab in the induction and maintenance phase in order to determine the cut-off points of the ustekinumab levels between which a clinical remission is expected in patients with inflammatory bowel disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •Over 18 years.
- •Patients treated with ustekinumab in induction and maintenance phase.
- •They must agree to participate in the clinical study, having previously signed the informed consent.
排除标准
- •Any patient who does not meet the inclusion criteria previously described and / or who refuses to participate in the study.
结局指标
主要结局
Determine breakpoints.
时间窗: Up to 44 weeks.
To determine the breakpoints for ustekinumab levels between which clinical remission is expected in patients with inflammatory bowel disease.
次要结局
未报告次要终点