Ulcerative Colitis
Conditions
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
Interventions
DIAGNOSTIC_TESTIntestinal 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)
Sponsors
Galapagos NV
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| 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 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 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 Ulcerative Colitis Endoscopic Index of Severity (UCEIS) during treatment with filgotinib | 10-16 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| • 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 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 | — |
| • 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 | — |
| 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 biochemical response and remission at the time of the follow-up endoscopy. | 10-16 weeks | — |
Other
| 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 |
| • 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 |
| • 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 |
| • 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 |
Countries
Netherlands
Outcome results
None listed