Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
100 participants
Study Classification
OBSERVATIONAL
Study Start Date
2025-05-08
Study Completion Date
2030-01-31
Brief Summary
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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.
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.
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Detailed Description
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Conditions
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Ulcerative Colitis
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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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.
* 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.
* Inability to provide informed consent.
* Non-English speaking.
* Patients presenting for a one-time consultation.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
collaborator
University of North Carolina, Chapel Hill
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Hans Herfarth, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina
Locations
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South Denver Gastroenterology
Denver, Colorado, United States
Site Status
RECRUITING
AdventHealth
Orlando, Florida, United States
Site Status
RECRUITING
University of Iowa Health Care
Iowa City, Iowa, United States
Site Status
RECRUITING
University of Louisville, Clinical Trials Unit
Louisville, Kentucky, United States
Site Status
RECRUITING
University Of Rochester Medical Center
Rochester, New York, United States
Site Status
RECRUITING
University of North Carolina
Chapel Hill, North Carolina, United States
Site Status
RECRUITING
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Site Status
RECRUITING
Southern Star Research Institute, LLC
San Antonio, Texas, United States
Site Status
RECRUITING
TIDHI Innovation Inc.
Toronto, Ontario, Canada
Site Status
RECRUITING
Countries
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United States
Canada
Central Contacts
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Facility Contacts
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References
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Dubinsky M, Bleakman AP, Panaccione R, Hibi T, Schreiber S, Rubin D, Dignass A, Redondo I, Gibble TH, Kayhan C, Travis S. Bowel Urgency in Ulcerative Colitis: Current Perspectives and Future Directions. Am J Gastroenterol. 2023 Nov 1;118(11):1940-1953. doi: 10.14309/ajg.0000000000002404. Epub 2023 Jun 12.
Reference Type
RESULT
Singh S, Ananthakrishnan AN, Nguyen NH, Cohen BL, Velayos FS, Weiss JM, Sultan S, Siddique SM, Adler J, Chachu KA; AGA Clinical Guidelines Committee. Electronic address: [email protected]. AGA Clinical Practice Guideline on the Role of Biomarkers for the Management of Ulcerative Colitis. Gastroenterology. 2023 Mar;164(3):344-372. doi: 10.1053/j.gastro.2022.12.007.
Reference Type
RESULT
Higgins PD, Schwartz M, Mapili J, Krokos I, Leung J, Zimmermann EM. Patient defined dichotomous end points for remission and clinical improvement in ulcerative colitis. Gut. 2005 Jun;54(6):782-8. doi: 10.1136/gut.2004.056358.
Reference Type
RESULT
Barnes EL, Hanson JS, Regueiro MD, Saha S, Sands BE, Rubin DT, Dubinsky MC, Siegel CA, Gazis DR, Crawford JM, Long MD. Older Adult Patients Use More Aminosalicylate Monotherapy Compared With Younger Patients With Inflammatory Bowel Disease: TARGET-IBD. J Clin Gastroenterol. 2022 Jul 1;56(6):529-535. doi: 10.1097/MCG.0000000000001557. Epub 2021 Jun 11.
Reference Type
RESULT
Tinsley A, Macklin EA, Korzenik JR, Sands BE. Validation of the functional assessment of chronic illness therapy-fatigue (FACIT-F) in patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2011 Dec;34(11-12):1328-36. doi: 10.1111/j.1365-2036.2011.04871.x. Epub 2011 Oct 17.
Reference Type
RESULT
Dubinsky MC, Clemow DB, Hunter Gibble T, Li X, Vermeire S, Hisamatsu T, Travis SPL. Clinical Effect of Mirikizumab Treatment on Bowel Urgency in Patients with Moderately to Severely Active Ulcerative Colitis and the Clinical Relevance of Bowel Urgency Improvement for Disease Remission. Crohns Colitis 360. 2022 Dec 13;5(1):otac044. doi: 10.1093/crocol/otac044. eCollection 2023 Jan.
Reference Type
RESULT
Outtier A, Gijbels L, Noman M, Verstockt B, Sabino J, Vermeire S, Ferrante M. Screening Failure in a Large Clinical Trial Centre for Inflammatory Bowel Diseases: Rates, Causes, and Outcomes. Inflamm Bowel Dis. 2023 Sep 1;29(9):1440-1445. doi: 10.1093/ibd/izac227.
Reference Type
RESULT
Bewtra M, Brensinger CM, Tomov VT, Hoang TB, Sokach CE, Siegel CA, Lewis JD. An optimized patient-reported ulcerative colitis disease activity measure derived from the Mayo score and the simple clinical colitis activity index. Inflamm Bowel Dis. 2014 Jun;20(6):1070-8. doi: 10.1097/MIB.0000000000000053.
Reference Type
RESULT
Long MD, Afzali A, Fischer M, Hudesman D, Abdalla M, McCabe R, Cohen BL, Ungaro RC, Harlan W, Hanson J, Konijeti G, Polyak S, Ritter T, Salzberg B, Seminerio J, English E, Zhang X, Sharma PP, Herfarth HH. Tofacitinib Response in Ulcerative Colitis (TOUR): Early Response After Initiation of Tofacitinib Therapy in a Real-world Setting. Inflamm Bowel Dis. 2023 Apr 3;29(4):570-578. doi: 10.1093/ibd/izac121.
Reference Type
RESULT
Ha C, Ullman TA, Siegel CA, Kornbluth A. Patients enrolled in randomized controlled trials do not represent the inflammatory bowel disease patient population. Clin Gastroenterol Hepatol. 2012 Sep;10(9):1002-7; quiz e78. doi: 10.1016/j.cgh.2012.02.004. Epub 2012 Feb 15.
Reference Type
RESULT
Dulai PS, Singh S, Jairath V, Wong E, Narula N. Integrating Evidence to Guide Use of Biologics and Small Molecules for Inflammatory Bowel Diseases. Gastroenterology. 2024 Mar;166(3):396-408.e2. doi: 10.1053/j.gastro.2023.10.033. Epub 2023 Nov 8.
Reference Type
RESULT
Lichtenstein GR, Yan S, Bala M, Hanauer S. Remission in patients with Crohn's disease is associated with improvement in employment and quality of life and a decrease in hospitalizations and surgeries. Am J Gastroenterol. 2004 Jan;99(1):91-6. doi: 10.1046/j.1572-0241.2003.04010.x.
Reference Type
RESULT
Ananthakrishnan AN, Weber LR, Knox JF, Skaros S, Emmons J, Lundeen S, Issa M, Otterson MF, Binion DG. Permanent work disability in Crohn's disease. Am J Gastroenterol. 2008 Jan;103(1):154-61. doi: 10.1111/j.1572-0241.2007.01561.x. Epub 2007 Dec 11.
Reference Type
RESULT
Shivashankar R, Tremaine WJ, Harmsen WS, Loftus EV Jr. Incidence and Prevalence of Crohn's Disease and Ulcerative Colitis in Olmsted County, Minnesota From 1970 Through 2010. Clin Gastroenterol Hepatol. 2017 Jun;15(6):857-863. doi: 10.1016/j.cgh.2016.10.039. Epub 2016 Nov 14.
Reference Type
RESULT
Herrinton LJ, Liu L, Lewis JD, Griffin PM, Allison J. Incidence and prevalence of inflammatory bowel disease in a Northern California managed care organization, 1996-2002. Am J Gastroenterol. 2008 Aug;103(8):1998-2006. doi: 10.1111/j.1572-0241.2008.01960.x.
Reference Type
RESULT
Loftus EV Jr, Schoenfeld P, Sandborn WJ. The epidemiology and natural history of Crohn's disease in population-based patient cohorts from North America: a systematic review. Aliment Pharmacol Ther. 2002 Jan;16(1):51-60. doi: 10.1046/j.1365-2036.2002.01140.x.
Reference Type
RESULT
Other Identifiers
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24-2191
Identifier Type: -
Identifier Source: org_study_id
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