RECRUITING

Mirikizumab Real World Protocol

Conditions

Ulcerative Colitis mirikizumab Omvoh MIRROR

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this observational study is to learn about how effective mirikizumab (Omvoh) is when treating patients with ulcerative colitis (UC) Does mirikizumab (Omvoh) lead to a reduction in symptoms at intervals throughout one year? Participants being prescribed mirikizumab (Omvoh) as part of their regular medical care for UC will answer online survey questions about their bowel habits for 1 year.

Official Title

MIrikizumab in UC - a Real-woRld prOspective multicenteR Registry

Quick Facts

Study Start:2025-05-08

Study Completion:2030-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06696014

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Adult patients, age 18 years or older, with UC, who within 2 weeks have been started on mirikizumab therapy for moderate to severe UC or who plan to begin this therapy within the next 2 weeks. The start of the mirikizumab treatment must have been or be initiated in the setting of standard-of-care therapy. * Anticipation that the patient will be followed by the participating center for the next 12 months. * Diagnosis of UC must be established based on standard clinical, radiographic, endoscopic, and histologic criteria as described below. * Superficial inflammation and/or ulceration (involving only the mucosa and submucosa) of the colon, which is continuous from the rectum extending proximally without skip lesions or complete rectal sparing (relative rectal sparing is allowed for patients receiving topical, rectal therapy; patchiness of endoscopic inflammation may be observed in patients with partially treated ulcerative colitis). * In patients with proctitis or left-sided ulcerative colitis, there may be an area of inflammation in the cecum, usually surrounding the appendiceal orifice. * No inflammation of the small intestine ("backwash ileitis" is allowed - non-stenotic superficial inflammation of the terminal ileal mucosa associated with severe pancolitis, which resolves following medical or surgical treatment of the colitis). * No features of Crohn's disease listed above. There is no minimum length of extension of UC required for inclusion in this study.	* Inability to provide informed consent. * Non-English speaking. * Patients presenting for a one-time consultation.

Inclusion Criteria

Exclusion Criteria

* Adult patients, age 18 years or older, with UC, who within 2 weeks have been started on mirikizumab therapy for moderate to severe UC or who plan to begin this therapy within the next 2 weeks. The start of the mirikizumab treatment must have been or be initiated in the setting of standard-of-care therapy.
* Anticipation that the patient will be followed by the participating center for the next 12 months.
* Diagnosis of UC must be established based on standard clinical, radiographic, endoscopic, and histologic criteria as described below.
* Superficial inflammation and/or ulceration (involving only the mucosa and submucosa) of the colon, which is continuous from the rectum extending proximally without skip lesions or complete rectal sparing (relative rectal sparing is allowed for patients receiving topical, rectal therapy; patchiness of endoscopic inflammation may be observed in patients with partially treated ulcerative colitis).
* In patients with proctitis or left-sided ulcerative colitis, there may be an area of inflammation in the cecum, usually surrounding the appendiceal orifice.
* No inflammation of the small intestine ("backwash ileitis" is allowed - non-stenotic superficial inflammation of the terminal ileal mucosa associated with severe pancolitis, which resolves following medical or surgical treatment of the colitis).
* No features of Crohn's disease listed above. There is no minimum length of extension of UC required for inclusion in this study.

* Inability to provide informed consent.
* Non-English speaking.
* Patients presenting for a one-time consultation.

Contacts and Locations

Study Contact

Emily English, MSW, CCRC

CONTACT

919-843-8105

emily_english@med.unc.edu

Principal Investigator

Hans Herfarth, MD, PhD

PRINCIPAL_INVESTIGATOR

University of North Carolina

Study Locations (Sites)

South Denver Gastroenterology, P.C.

Denver, Colorado, 80113

United States

University of Iowa

Iowa City, Iowa, 52242

United States

University of North Carolina

Chapel Hill, North Carolina, 27599

United States

Southern Star Research Institute

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

Hans Herfarth, MD, PhD, PRINCIPAL_INVESTIGATOR, University of North Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-08

Study Completion Date2030-01

Study Record Updates

Study Start Date2025-05-08

Study Completion Date2030-01

Terms related to this study

Keywords Provided by Researchers

mirikizumab
Omvoh
MIRROR

Additional Relevant MeSH Terms

Ulcerative Colitis