Clinical trial NCT05653791: Early Intestinal Ultrasound in Predicting Treatment Response to Filgotinib in Ulcerative Colitis
Official title: Intestinal Ultrasonography in Ulcerative Colitis Patients Treated With Filgotinib
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ulcerative Colitis
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Galapagos NV
First posted: 2022-12-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with moderate to severe UC starting on filgotonib treatment

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


Eligibility criteria: Inclusion Criteria:

* ≥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

Exclusion Criteria:

* Pregnancy
* Inability to give informed consent
* Proctitis only
* Ongoing gastroenteritis
* (Sub)total colectomy
* Obesity (BMI \>35 kg/m²)

Primary outcomes:
measure: 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
timeFrame: 10-16 weeks
measure: 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
timeFrame: 10-16 weeks
measure: 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
timeFrame: 10-16 weeks
measure: 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
timeFrame: 10-16 weeks
Secondary outcomes:
measure: 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
timeFrame: 10-16 weeks
measure: 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
timeFrame: 10-16 weeks
measure: • 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.
timeFrame: 10-16 weeks
measure: • 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
timeFrame: 10-16 weeks
measure: • to evaluate IUS parameters (as measured in B-mode) in predicting biochemical remission at 1 year (as defined by fecal calprotectin< 150 ug/g)
timeFrame: 52 weeks / 1 year
measure: • to evaluate IUS parameters (as measured in B-mode) in predicting cortico-steroid-free remission at 1 year
timeFrame: 52 weeks / 1 year
measure: • 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)
timeFrame: 52 weeks / 1 year
measure: • 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.
timeFrame: 4 weeks
measure: • 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.
timeFrame: 4 weeks
measure: • to evaluate individual wall layer thickness, with special regard to the submucosa, in relation to response to treatment
timeFrame: 10-16 weeks
measure: • to describe SWE (measured in kPa) in patients with moderate to severe UC
timeFrame: 10-16 weeks
measure: • correlate SWE (measured in kPa) with endoscopic findings of disease severity (measured by the Mayo endoscopic subscore)
timeFrame: 10-16 weeks
measure: • correlate SWE (measured in kPa) with endoscopic findings of disease severity (measured by the UCEIS subscore)
timeFrame: 10-16 weeks
measure: • to evaluate correlation between SWE findings and characteristics of the submucosa, including wall layer thickness and hyperechogenicity
timeFrame: 10-16 weeks
measure: • to evaluate the correlation between segmental healing upon endoscopy and IUS
timeFrame: 10-16 weeks
Other outcomes:
measure: • Can early (baseline to week 4) changes in IUS parameters (B-mode and SWE) predict long-term clinical (defined by a decrease of ≥ 3 in SCCAI) response at 1 year
timeFrame: between baseline and 52 weeks / 1 year
measure: • Can early (baseline to week 4) changes in IUS parameters (B-mode and SWE) predict long-term clinical (defined by SCCAI ≤ 2) remission at 1 year
timeFrame: between baseline and 52 weeks / 1 year
measure: • Can early (baseline to week 4) changes in IUS parameters predict long-term biochemical response at 1 year (measured by fecal calprotectin <250 µg/g )
timeFrame: between baseline and 52 weeks / 1 year
measure: • to explore whether early (baseline to week 4) changes in IUS parameters can predict long-term biochemical remission at 1 year (measured by fecal calprotectin <150 µg/g )
timeFrame: between baseline and 52 weeks / 1 year
Locations:
city: Amsterdam-Zuidoost
country: Netherlands
facility: Amsterdam UMC
state: Noord-holland
Study officials:
References: