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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05653791
Other study ID # W22_205 # 22.254
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 1, 2022
Est. completion date October 1, 2024

Study information

Verified date December 2022
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date October 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
Netherlands Amsterdam UMC Amsterdam-Zuidoost Noord-holland

Sponsors (2)

Lead Sponsor Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Galapagos NV

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Other • 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
Other • 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
Other • 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
Other • 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
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary • 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
Secondary • 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
Secondary • 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
Secondary • to evaluate IUS parameters (as measured in B-mode) in predicting cortico-steroid-free remission at 1 year 52 weeks / 1 year
Secondary • 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
Secondary • 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
Secondary • 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
Secondary • to evaluate individual wall layer thickness, with special regard to the submucosa, in relation to response to treatment 10-16 weeks
Secondary • to describe SWE (measured in kPa) in patients with moderate to severe UC 10-16 weeks
Secondary • correlate SWE (measured in kPa) with endoscopic findings of disease severity (measured by the Mayo endoscopic subscore) 10-16 weeks
Secondary • correlate SWE (measured in kPa) with endoscopic findings of disease severity (measured by the UCEIS subscore) 10-16 weeks
Secondary • to evaluate correlation between SWE findings and characteristics of the submucosa, including wall layer thickness and hyperechogenicity 10-16 weeks
Secondary • to evaluate the correlation between segmental healing upon endoscopy and IUS 10-16 weeks
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