Early Intestinal Ultrasound in Predicting Treatment Response to Filgotinib in Ulcerative Colitis

NCT05653791 | Unknown

• 1 other identifier: W22_205 # 22.254
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (15)

• 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 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

Other Outcomes (4)

• • 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

Study Arms (1)

Filgotinib treated patients

Diagnostic Test: Intestinal ultrasound

Interventions

Intestinal ultrasound DIAGNOSTIC_TEST

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)

Filgotinib treated patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with moderate to severe UC starting on filgotonib treatment

You may qualify if:

• ≥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

You may not qualify if:

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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Galapagos NV: collaborator

Study Sites (1)

Amsterdam UMC

Amsterdam-Zuidoost, North Holland, 1105AZ, Netherlands

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. K.B. Gecse, MD PhD

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: December 16, 2022
• Study Start: October 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: October 1, 2024
• Last Updated: December 16, 2022

Record last verified: 2022-12

Locations

NL (1)