Ulcerative Colitis (UC)NCT07188727
Comparative Outcomes of Ulcerative Colitis Patients With Mayo Endoscopic Score 1 and Histologic Activity Versus Mayo Endoscopic Score 2
An observational study of Ulcerative Colitis (UC), run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
This retrospective study examines patients with ulcerative colitis who initiated advanced therapy for their disease. In clinical practice, patients with only mild inflammation on endoscopy (Mayo Endoscopic Subscore 1, or MES1) often do not undergo treatment optimization or therapy change. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis (UC)
- How many people
- 159 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2019to 1 May 2025
- 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: Adult patients diagnosed with ulcerative colitis who initiated advanced therapy between 2019 and 2025. Patients were stratified according to baseline Mayo Endoscopic Subscore (MES1 or MES2) and had available histologic assessment from endoscopic biopsies.
Who may be able to join
- Confirmed diagnosis of UC (by routine clinical, radiographic, endoscopic and pathologic criteria);
- Patients starting a new advanced treatment for UC (either biologic agents or small molecules);
- Patients with endoscopic MES of 1 or 2 at the endoscopic reassessment (conducted after 12 ± 3 months following the initiation of advanced therapy)
Who cannot join
- Patients with unclassified colitis or Crohn's disease;
- Previous colonic surgery (eg. Pouch);
- Patients for whom biopsies were not obtained at the time of endoscopic reassessment (conducted after 12 months following the initiation of advanced therapy);
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Refining Clinical Practice in Ulcerative Colitis: The Prognostic Value of Histologic Remission - A Monocentric Retrospective Study
This retrospective study examines patients with ulcerative colitis who initiated advanced therapy for their disease. In clinical practice, patients with only mild inflammation on endoscopy (Mayo Endoscopic Subscore 1, or MES1) often do not undergo treatment optimization or therapy change. We stratified these patients based on histologic findings from biopsy samples and compared them with patients who had greater endoscopic activity (MES2). We evaluated long-term outcomes, including surgery and hospitalization, to determine whether current management strategies for patients with mild endoscopic disease should be reconsidered.
- Conditions
- Ulcerative Colitis (UC)
- Keywords
- Ulcerative Colitis, Histology, Mayo Endoscopic Score, Outcomes
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mayo Endoscopic Score 1 | Patients with ulcerative colitis who initiated advanced therapy and had mild endoscopic activity at baseline (Mayo Endoscopic Subscore 1). Histologic findings were recorded, and long-term outcomes such as surgery and hospitalization were assessed. | |
| Mayo Endoscopic Score 2 | Patients with ulcerative colitis who initiated advanced therapy and had moderate endoscopic activity at baseline (Mayo Endoscopic Subscore 2). Long-term outcomes, including surgery and hospitalization, were evaluated for comparison with the MES1 group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Composite Outcome
The composite outcome includes any of the following events: escalation of medical therapy, hospitalization related to ulcerative colitis, or surgery related to ulcerative colitis
Measured: From enrollment to end of follow-up at 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start1 Sep 2019
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferdinando D'amico, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188727
- Sponsor's protocol ID
- MES1VSMES2
- Status last verified
- Aug 2025
- First submitted
- 16 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refining Clinical Practice in Ulcerative Colitis: The Prognostic Value of Histologic Remission - A Monocentric Retrospective Study
- ClinicalTrials.gov ID
- NCT07188727
- Acronym / sponsor ID
- MES1VSMES2
- Conditions
- Ulcerative Colitis (UC)
- Keywords
- Ulcerative Colitis, Histology, Mayo Endoscopic Score, Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 23 Sep 2025 (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.
This retrospective study examines patients with ulcerative colitis who initiated advanced therapy for their disease. In clinical practice, patients with only mild inflammation on endoscopy (Mayo Endoscopic Subscore 1, or MES1) often do not undergo treatment optimization or therapy change. We stratified these patients based on histologic findings from biopsy samples and compared them with patients who had greater endoscopic activity (MES2). We evaluated long-term outcomes, including surgery and hospitalization, to determine whether current management strategies for patients with mild endoscopic disease should be reconsidered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mayo Endoscopic Score 1 | – | –Patients with ulcerative colitis who initiated advanced therapy and had mild endoscopic activity at baseline (Mayo Endoscopic Subscore 1). Histologic findings were recorded, and long-term outcomes such as surgery and hospitalization were assessed. |
| Mayo Endoscopic Score 2 | – | –Patients with ulcerative colitis who initiated advanced therapy and had moderate endoscopic activity at baseline (Mayo Endoscopic Subscore 2). Long-term outcomes, including surgery and hospitalization, were evaluated for comparison with the MES1 group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with ulcerative colitis who initiated advanced therapy between 2019 and 2025. Patients were stratified according to baseline Mayo Endoscopic Subscore (MES1 or MES2) and had available histologic assessment from endoscopic biopsies.
Key inclusion criteria (3 listed)
- Confirmed diagnosis of UC (by routine clinical, radiographic, endoscopic and pathologic criteria);
- Patients starting a new advanced treatment for UC (either biologic agents or small molecules);
- Patients with endoscopic MES of 1 or 2 at the endoscopic reassessment (conducted after 12 ± 3 months following the initiation of advanced therapy)
Key exclusion criteria (3 listed)
- Patients with unclassified colitis or Crohn's disease;
- Previous colonic surgery (eg. Pouch);
- Patients for whom biopsies were not obtained at the time of endoscopic reassessment (conducted after 12 months following the initiation of advanced therapy);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Composite Outcome
Time frame: From enrollment to end of follow-up at 36 months
The composite outcome includes any of the following events: escalation of medical therapy, hospitalization related to ulcerative colitis, or surgery related to ulcerative colitis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
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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 (UC), run by IRCCS San Raffaele at 1 site in Italy.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 23 Sep 2025. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of Composite Outcome (time frame: From enrollment to end of follow-up at 36 months). 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 23 Sep 2025.