MIrikizumab in UC - a Real-woRld prOspective multicenteR Registry

Status: Recruiting
Location: See all (9) locations...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

⁃ Criteria for diagnosis of UC The following diagnostic criteria were developed by the NIDDK IBD Genetics Consortium and are provided as guidelines to complete documentation on individuals with Ulcerative Colitis.

⁃ A) Symptoms including one or more: diarrhea, rectal bleeding, abdominal pain, fever, extraintestinal manifestations, weight loss, or failure to thrive.

⁃ AND

⁃ B) Symptoms on two or more occasions separated by at least 8 weeks or ongoing symptoms of at least 6 weeks duration.

⁃ AND

⁃ C) Endoscopic Findings compatible with UC:

• 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.

Locations
United States
Colorado
South Denver Gastroenterology
RECRUITING
Denver
Florida
AdventHealth
RECRUITING
Orlando
Iowa
University of Iowa Health Care
RECRUITING
Iowa City
Kentucky
University of Louisville, Clinical Trials Unit
RECRUITING
Louisville
North Carolina
University of North Carolina
RECRUITING
Chapel Hill
New York
University Of Rochester Medical Center
RECRUITING
Rochester
South Carolina
Medical University of South Carolina (MUSC)
RECRUITING
Charleston
Texas
Southern Star Research Institute, LLC
RECRUITING
San Antonio
Other Locations
Canada
TIDHI Innovation Inc.
RECRUITING
Toronto
Contact Information
Primary
Emily English, MSW, CCRC
emily_english@med.unc.edu
919-843-8105
Time Frame
Start Date: 2025-05-08
Estimated Completion Date: 2030-01
Participants
Target number of participants: 100
Sponsors
Collaborators: Eli Lilly and Company
Leads: University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov

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