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

NCT ID: NCT07188727

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 159 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2025-05-01

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)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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);

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Ferdinando D'amico

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS San Raffaele Hospital

Milan, MI, Italy

Countries

Italy

Other Identifiers

MES1VSMES2

Identifier Type: -

Identifier Source: org_study_id