Mirikizumab Real World Protocol

Launched by UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL · Nov 15, 2024

Keywords

ClinConnect Summary

The Mirikizumab Real World Protocol is a study designed to understand how well mirikizumab (also known as Omvoh) works in treating people with ulcerative colitis (UC). This observational study aims to find out if mirikizumab can help reduce symptoms of UC over a period of one year. Participants who are starting mirikizumab as part of their usual treatment will fill out online surveys about their bowel habits and experiences with the medication throughout the year.

To be eligible for this study, participants need to be adults aged 18 or older who have been diagnosed with moderate to severe ulcerative colitis and are beginning treatment with mirikizumab within the next two weeks. They should also be expected to stay under the care of the participating medical center for the entire year. It's important to note that participants will need to be able to speak English and provide informed consent to join the study. This trial is currently not recruiting participants yet, but it represents an opportunity to contribute to understanding how effective this medication is for managing ulcerative colitis.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• • 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.
• Exclusion Criteria:
• Patients will be excluded if they meet any of the following criteria:
• • Inability to provide informed consent.
• • Non-English speaking.
• • Patients presenting for a one-time consultation.