Mirikizumab Real World Protocol

Purpose

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.

Condition

  • Ulcerative Colitis

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Recruiting Locations

South Denver Gastroenterology
Denver, Colorado 80113
Contact:
Samantha Reiff
303-406-4288
sreiff@gutfeelings.com

AdventHealth
Orlando, Florida 32804
Contact:
Amber Barrick
407-619-1316
amber.barrick@adventhealth.com

University of Iowa Health Care
Iowa City, Iowa 52242
Contact:
Megan Sharer
319-467-4169
Megan-sharer@uiowa.edu

University of Louisville, Clinical Trials Unit
Louisville, Kentucky 40202
Contact:
Kimiko Kasama
502-852-7402
Kimiko.kasama@louisville.edu

University Of Rochester Medical Center
Rochester, New York 14642
Contact:
Munazza Zakirullah
munazza_zakir@urmc.rochester.edu

University of North Carolina
Chapel Hill, North Carolina 27599
Contact:
Emily English, MSW, CCRC
919-843-8105
emily_english@med.unc.edu

Medical University of South Carolina (MUSC)
Charleston, South Carolina 29425
Contact:
Angela Francisco
843-792-3710
millare@musc.edu

Southern Star Research Institute, LLC
San Antonio, Texas 78229
Contact:
Mireya Garza
210-581-2812
mireya.garza@ssrinstitute.com

More Details

NCT ID
NCT06696014
Status
Recruiting
Sponsor
University of North Carolina, Chapel Hill

Study Contact

Emily English, MSW, CCRC
919-843-8105
emily_english@med.unc.edu