Observing the effects of mirikizumab on ulcerative colitis symptoms
MIrikizumab in UC - a Real-woRld prOspective multicenteR Registry
This study is testing how well mirikizumab helps people with ulcerative colitis feel better by looking at their symptoms over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Drugs / interventions | mirikizumab |
| Locations | 9 sites (Denver, Colorado and 8 other locations) |
| Trial ID | NCT06696014 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of mirikizumab (Omvoh) in treating patients with ulcerative colitis (UC) over a one-year period. Participants who have recently started or are about to start mirikizumab therapy will complete online surveys regarding their bowel habits and symptoms. The study seeks to gather real-world data on symptom reduction and overall treatment outcomes for patients receiving this medication as part of their standard care.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have been diagnosed with moderate to severe ulcerative colitis and are starting mirikizumab therapy.
Not a fit: Patients who are not starting mirikizumab therapy or those with mild ulcerative colitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness of mirikizumab for managing ulcerative colitis symptoms.
How similar studies have performed: While this approach is observational, similar studies have shown promise in evaluating real-world treatment effectiveness for ulcerative colitis.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Denver, Colorado and 8 other locations
- South Denver Gastroenterology — Denver, Colorado, United States (Recruiting)
- AdventHealth — Orlando, Florida, United States (Recruiting)
- University of Iowa Health Care — Iowa City, Iowa, United States (Recruiting)
- University of Louisville, Clinical Trials Unit — Louisville, Kentucky, United States (Recruiting)
- University Of Rochester Medical Center — Rochester, New York, United States (Recruiting)
- University of North Carolina — Chapel Hill, North Carolina, United States (Recruiting)
- Medical University of South Carolina (MUSC) — Charleston, South Carolina, United States (Recruiting)
- Southern Star Research Institute, LLC — San Antonio, Texas, United States (Recruiting)
- TIDHI Innovation Inc. — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Hans Herfarth, MD, PhD — University of North Carolina
- Study coordinator: Emily English, MSW, CCRC
- Email: emily_english@med.unc.edu
- Phone: 919-843-8105
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.