Mirikizumab Real World Protocol

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.

Conditions

Ulcerative Colitis

Study Overview

Study Details

Study overview

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.

MIrikizumab in UC - a Real-woRld prOspective multicenteR Registry

Mirikizumab Real World Protocol

Condition
Ulcerative Colitis
Intervention / Treatment

-

Contacts and Locations

Denver

South Denver Gastroenterology, P.C., Denver, Colorado, United States, 80113

Iowa City

University of Iowa, Iowa City, Iowa, United States, 52242

Chapel Hill

University of North Carolina, Chapel Hill, North Carolina, United States, 27599

San Antonio

Southern Star Research Institute, San Antonio, Texas, United States, 78229

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of North Carolina, Chapel Hill,

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

Study Record Dates

2030-01