Early Intestinal Ultrasound in Predicting Treatment Response to Filgotinib in Ulcerative Colitis (STEER)

Intestinal Ultrasonography in Ulcerative Colitis Patients Treated With Filgotinib

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

Study Overview

• Status: Active, not recruiting
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Diagnostic test: Intestinal ultrasound

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Netherlands
  • Noord-holland
    • Amsterdam-Zuidoost, Noord-holland, Netherlands, 1105AZ
      • Amsterdam UMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with moderate to severe UC starting on filgotonib treatment

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Filgotinib treated patients	Diagnostic test: Intestinal ultrasound; Ulcerative colitis patients treated with filgotinib will undergo intestinal transabdominal ultrasound at baseline, week 4 and at the time of the follow-up endoscopy (week 10-16)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	B-mode: bowel wall thickness (BWT), colour doppler signal (CDS), loss of stratification, loss of haustration and presence of lymph nodes	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 biochemical response and remission at the time of the 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 biochemical remission at 1 year (as defined by fecal calprotectin< 150 ug/g)		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 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 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 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 describe SWE (measured in kPa) in patients with moderate to severe UC		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 correlation between SWE findings and characteristics of the submucosa, including wall layer thickness and hyperechogenicity		10-16 weeks
• to evaluate the correlation between segmental healing upon endoscopy and IUS		10-16 weeks

Other Outcome Measures

Outcome Measure	Time Frame
• 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	between baseline and 52 weeks / 1 year
• 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	between baseline and 52 weeks / 1 year
• 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 )	between baseline and 52 weeks / 1 year
• 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 )	between baseline and 52 weeks / 1 year

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: Galapagos NV

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: November 11, 2022
• First Submitted That Met QC Criteria: December 8, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Actual): December 16, 2022
• Last Update Submitted That Met QC Criteria: December 8, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: W22_205 # 22.254

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No