Ulcerative ColitisSTEERNCT05653791
Early Intestinal Ultrasound in Predicting Treatment Response to Filgotinib in Ulcerative Colitis
An observational study of Ulcerative Colitis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Intestinal ultrasound
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2022to 1 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with moderate to severe UC starting on filgotonib treatment
Who may be able to join
- ≥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
Who cannot join
- Pregnancy
- Inability to give informed consent
- Proctitis only
- Ongoing gastroenteritis
- (Sub)total colectomy
- Obesity (BMI >35 kg/m²)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Ulcerative Colitis
- Being tested
- Intestinal ultrasound
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intestinal ultrasoundDiagnostic 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)
| Study group | Role | What they receive |
|---|---|---|
| Filgotinib treated patients | Not described Receives: Diagnostic Test: Intestinal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
B-mode: bowel wall thickness (BWT), colour doppler signal (CDS), loss of stratification, loss of haustration and presence of lymph nodes
Measured: 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
Measured: 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.
Measured: 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
Measured: 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)
Measured: 52 weeks / 1 year
• to evaluate IUS parameters (as measured in B-mode) in predicting cortico-steroid-free remission at 1 year
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 4 weeks
• to evaluate individual wall layer thickness, with special regard to the submucosa, in relation to response to treatment
Measured: 10-16 weeks
• to describe SWE (measured in kPa) in patients with moderate to severe UC
Measured: 10-16 weeks
• correlate SWE (measured in kPa) with endoscopic findings of disease severity (measured by the Mayo endoscopic subscore)
Measured: 10-16 weeks
• correlate SWE (measured in kPa) with endoscopic findings of disease severity (measured by the UCEIS subscore)
Measured: 10-16 weeks
• to evaluate correlation between SWE findings and characteristics of the submucosa, including wall layer thickness and hyperechogenicity
Measured: 10-16 weeks
• to evaluate the correlation between segmental healing upon endoscopy and IUS
Measured: 10-16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start1 Oct 2022
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Lakefront Biotherapeutics NV
- Responsible party
- Principal investigator, Krisztina Gecse, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653791
- Sponsor's protocol ID
- W22_205 # 22.254
- Acronym
- STEER
- Status last verified
- Dec 2022
- First submitted
- 11 Nov 2022
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Ultrasonography in Ulcerative Colitis Patients Treated With Filgotinib
- ClinicalTrials.gov ID
- NCT05653791
- Acronym / sponsor ID
- STEER / W22_205 # 22.254
- Conditions
- Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Lakefront Biotherapeutics NV
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Filgotinib treated patients | – | Diagnostic Test: Intestinal ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with moderate to severe UC starting on filgotonib treatment
Key inclusion criteria (5 listed)
- ≥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
Key exclusion criteria (6 listed)
- Pregnancy
- Inability to give informed consent
- Proctitis only
- Ongoing gastroenteritis
- (Sub)total colectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intestinal ultrasoundUlcerative 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) | Diagnostic test | Filgotinib treated patients |
Primary outcome
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 10-16 weeks
15 secondary outcomes
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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 52 weeks / 1 year
• to evaluate IUS parameters (as measured in B-mode) in predicting cortico-steroid-free remission at 1 year
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 4 weeks
• to evaluate individual wall layer thickness, with special regard to the submucosa, in relation to response to treatment
Time frame: 10-16 weeks
• to describe SWE (measured in kPa) in patients with moderate to severe UC
Time frame: 10-16 weeks
• correlate SWE (measured in kPa) with endoscopic findings of disease severity (measured by the Mayo endoscopic subscore)
Time frame: 10-16 weeks
• correlate SWE (measured in kPa) with endoscopic findings of disease severity (measured by the UCEIS subscore)
Time frame: 10-16 weeks
• to evaluate correlation between SWE findings and characteristics of the submucosa, including wall layer thickness and hyperechogenicity
Time frame: 10-16 weeks
• to evaluate the correlation between segmental healing upon endoscopy and IUS
Time frame: 10-16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 10-16 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2022.