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OpenTrials
Completed

NCT Number: NCT07695636

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS San Raffaele

Milan, Mi, 20132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Clinical remission (CR) rate at week 12.

    Time frame: week 12

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

EFFECTIVENESS AND SAFETY OF MIRIKIZUMB IN PATIENTS WITH MODERATE-TO-SEVERE ULCERATIVE COLITIS: A REAL-LIFE RETROSPECTIVE MULTICENTRE STUDY

Acronym: MIRI REAL

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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