Effectiveness and Safety of Mirikizumab in Patients With Moderate-to-severe Ulcerative Colitis: a Real-life Retrospective Multicenter Study

NCT07695636 | Completed

• 1 other identifier: MIRI REAL
• Study Type: observational
• Target: 282
• Locations: 1 country
• Sites: 1

Brief Summary

This is a real-life, multicenter, retrospective observational study with the aim to evaluate effectiveness and safety of Mirikizumab in a real life setting from the baseline up to manteinance at 12, 24 and 52 weeks. Patients with UC who have started mirikizumab will be included. Patients \> 18 years, with no distinction based on age, demographic group, special population, or general health status will be included. Eligible patients will be identified at each participating center among those receiving mirikizumab as part of routine clinical practice.The primary objective of this study is to evaluate the effectiveness of treatment in achieving clinical remission at week 12, as well as endoscopic remission at weeks 24 and 52. The secondary objectives are to assess changes over time in clinical, biochemical, and imaging parameters. Specifically, the study will evaluate changes in bowel urgency as measured by the Urgency Numeric Rating Scale (NRS), as well as changes in fecal calprotectin and C-reactive protein (CRP) levels from baseline to weeks 12, 24, and 52.

Conditions

Ulcerative Colitis (UC)

Outcome Measures

Primary Outcomes (1)

• Clinical remission (CR) rate at week 12.

  week 12

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

Patients \> 18 years, with no distinction based on age, demographic group, special population, or general health status will be included. Eligible patients will be identified at each participating center among those receiving mirikizumab as part of routine clinical practice.

You may qualify if:

• Established diagnosis of UC according to the current ECCO Guidelines;
• Age ≥18 years old;
• Patients must have received mirikizumab as UC treatment, as per clinical practice;
• At least 12 weeks follow-up visits after baseline;

You may not qualify if:

• Diagnosis of undetermined IBD, CD or other gastrointestinal inflammatory conditions;
• Age \< 18 years-old;
• Acute severe IBD complications necessitating hospitalization at baseline;

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele

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: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start: January 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: July 10, 2026

Record last verified: 2026-07

Locations

IT (1)