Comparative Outcomes of Ulcerative Colitis Patients With Mayo Endoscopic Score 1 and Histologic Activity Versus Mayo Endoscopic Score 2

NCT07188727 | Completed

• 1 other identifier: MES1VSMES2
• Study Type: observational
• Target: 159
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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

  From enrollment to end of follow-up at 36 months

Study Arms (2)

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.

Eligibility Criteria

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

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.

You may qualify if:

• 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)

You may not qualify if:

• 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);

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele Hospital

Milan, MI, 20132, Italy

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: MD, PhD

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 23, 2025
• Study Start: September 1, 2019
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-08

Locations

IT (1)