Intestinal Ultrasonography in Ulcerative Colitis Patients Treated With Filgotinib
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Evaluate the change in intestinal ultrasound parameters to predict endoscopic remission as defined by the follow-up endoscopy and measured by the Mayo endoscopic subscore during treatment with filgotinib
研究概览
简要总结
Objective disease assessment in inflammatory bowel diseases at the time of treatment initiation and during follow-up has become gold standard. However, biomarkers, such as C-reactive protein and fecal calprotectin, fail to provide information on disease extent, location or complications. Repeated endoscopic assessments are performed to evaluate mucosal response to treatment, though associated costs, availability, invasiveness and patient preference are considerable limitations. Recently, intestinal ultrasound (IUS) has gained significant momentum as a non-invasive, easily accessible and low-cost alternative for objective assessment. Accordingly, the ECCO-ESGAR guideline recognizes IUS as a potential tool for the diagnosis and for the monitoring of IBD.
Our study aim is to evaluate the change in intestinal ultrasound parameters (as measured by B-mode and SWE at baseline and week 4) to predict endoscopic response and remission as defined by the follow-up endoscopy and measured by the Mayo endoscopic subscore and the UCEIS during treatment with filgotinib
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
- 否
入选标准
- •≥18 years of age
- •Endoscopic and/or histological confirmed diagnosis of UC
- •UC disease extent proximal to the rectum (ie, left-sided colitis or pancolitis)
- •Moderately to severely active UC, defined by an endoscopic Mayo score of ≥ 2
- •Indication for receiving filgotinib treatment
排除标准
- •Pregnancy
- •Inability to give informed consent
- •Proctitis only
- •Ongoing gastroenteritis
- •(Sub)total colectomy
- •Obesity (BMI >35 kg/m²)
结局指标
主要结局
Evaluate the change in intestinal ultrasound parameters to predict endoscopic remission as defined by the follow-up endoscopy and measured by the Mayo endoscopic subscore during treatment with filgotinib
时间窗: 10-16 weeks
Evaluate the change in intestinal ultrasound parameters to predict endoscopic remission as defined by the follow-up endoscopy and measured by the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) during treatment with filgotinib
时间窗: 10-16 weeks
Evaluate the change in intestinal ultrasound parameters to predict endoscopic response as defined by the follow-up endoscopy and measured by the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) during treatment with filgotinib
时间窗: 10-16 weeks
Evaluate the change in intestinal ultrasound parameters to predict endoscopic response as defined by the follow-up endoscopy measured by the Mayo endoscopic subscore during treatment with filgotinib
时间窗: 10-16 weeks
次要结局
- • to evaluate IUS parameters (as measured in B-mode) in predicting biochemical remission at 1 year (as defined by fecal calprotectin< 150 ug/g)(52 weeks / 1 year)
- • to evaluate if addition of calprotectin to early IUS (at week 4) could better predict endoscopic response as defined by the follow-up endscopy than IUS or calprotectin alone.(4 weeks)
- • to describe SWE (measured in kPa) in patients with moderate to severe UC(10-16 weeks)
- • to evaluate correlation between SWE findings and characteristics of the submucosa, including wall layer thickness and hyperechogenicity(10-16 weeks)
- evaluate the change in IUS parameters (B-mode and shear-wave elastography (SWE; in kPa) at baseline and week 4) to predict clinical response during follow-up endoscopy(10-16 weeks)
- evaluate the change in IUS parameters (B-mode and SWE; measured in kPa) at baseline and week 4) to predict clinical remission during follow-up endoscopy(10-16 weeks)
- • to evaluate the change in IUS parameters (as measured by B-mode and SWE at baseline and week 4) to predict histological remission at the time of the follow-up endoscopy(10-16 weeks)
- • to evaluate IUS parameters (as measured in B-mode) in predicting clinical remission at 1 year (as defined by the Simple Clinical Colitis Activity Index (SCCAI) ≤ 2)(52 weeks / 1 year)
- • to evaluate IUS parameters (as measured in B-mode) in predicting cortico-steroid-free remission at 1 year(52 weeks / 1 year)
- • to evaluate the change in IUS parameters (as measured by B-mode and SWE at baseline and week 4) to predict biochemical response and remission at the time of the follow-up endoscopy.(10-16 weeks)
- • correlate SWE (measured in kPa) with endoscopic findings of disease severity (measured by the Mayo endoscopic subscore)(10-16 weeks)
- • correlate SWE (measured in kPa) with endoscopic findings of disease severity (measured by the UCEIS subscore)(10-16 weeks)
- • to evaluate if addition of calprotectin to early IUS (at week 4) could better predict endoscopic remission as defined by the follow-up endscopy than IUS or calprotectin alone.(4 weeks)
- • to evaluate individual wall layer thickness, with special regard to the submucosa, in relation to response to treatment(10-16 weeks)
- • to evaluate the correlation between segmental healing upon endoscopy and IUS(10-16 weeks)
研究者
Krisztina Gecse
Dr. K.B. Gecse, MD PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)