Early Intestinal Ultrasound in Predicting Treatment Response to Filgotinib in Ulcerative Colitis
- Conditions
- Ulcerative Colitis
- Interventions
- Diagnostic Test: Intestinal ultrasound
- Registration Number
- NCT05653791
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- ≥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
- Pregnancy
- Inability to give informed consent
- Proctitis only
- Ongoing gastroenteritis
- (Sub)total colectomy
- Obesity (BMI >35 kg/m²)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Filgotinib treated patients Intestinal ultrasound -
- Primary Outcome Measures
Name Time Method 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 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 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 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 10-16 weeks
- Secondary Outcome Measures
Name Time Method • to evaluate correlation between SWE findings and characteristics of the submucosa, including wall layer thickness and hyperechogenicity 10-16 weeks • 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 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 B-mode: bowel wall thickness (BWT), colour doppler signal (CDS), loss of stratification, loss of haustration and presence of lymph nodes
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
Trial Locations
- Locations (1)
Amsterdam UMC
🇳🇱Amsterdam-Zuidoost, Noord-holland, Netherlands