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

Completed

• Conditions: Ulcerative Colitis (UC)

• Registration Number: NCT07188727
• Lead Sponsor: IRCCS San Raffaele

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-01
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01
• Status Verified: 2025-08
• Study First Submitted: 2025-09-16
• Study First Submitted QC: 2025-09-16
• Last Update Submitted: 2025-09-16
• Study First Posted: 2025-09-23
• Last Update Posted: 2025-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

• 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)

Exclusion Criteria

• 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);

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Composite Outcome	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

Trial Locations

Locations (1)

IRCCS San Raffaele Hospital; 🇮🇹 Milan, MI, Italy