Mirikizumab Real World Protocol

Official title

MIrikizumab in UC - a Real-woRld prOspective multicenteR Registry

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.

Primary outcome measures

• induction of clinical response as evaluated by the Simple Clinical Colitis Activity Index (SCCAI) for the patient-reported outcomes. [Time frame: Weeks 1,2,4,8,12,18,24,36, and 52 after the start of therapy (each time point will be assessed separately)]

Secondary outcome measures (7)

• Remission as measured by Patient-Reported Outcomes Measurement Information System (PROMIS)-Depression Scoreoint will be assessed separately) (as measured by various PROs as outlined in methods) [Time frame: Weeks 0, 12, 24, and 52.]
• Remission as measured by PROMIS-Anxiety Score [Time frame: Weeks 0, 12, 24, and 52]
• Remission as measured by PROMIS-Sleep Score [Time frame: Weeks 0, 12, 24, and 52]
• Remission as measured by PROMIS-Social Satisfaction Score [Time frame: Weeks 0, 12, 24, and 52]
• Remission as measured by Likert scale urgency Score [Time frame: Weeks 1,2,4,8,12,18,24,36, and 52 after the start of therapy]
• Remission as measured by Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Scale Score [Time frame: Baseline (Week 0), Weeks 12, 24, and 52]
• Remission as measured by The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) score [Time frame: Weeks 0,4,8,12,18,24,36 and 52]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 8 centers

• South Denver Gastroenterology — Denver
• AdventHealth — Orlando
• University of Iowa Health Care — Iowa City
• University of Louisville, Clinical Trials Unit — Louisville
• University Of Rochester Medical Center — Rochester
• University of North Carolina — Chapel Hill
• Medical University of South Carolina (MUSC) — Charleston
• Southern Star Research Institute, LLC — San Antonio

Canada · 1 center

• TIDHI Innovation Inc. — Toronto

Publications

• 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. PMID 37436151
• 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: clinicalpractice@gastro.org. 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. PMID 36822736
• 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. PMID 15888785
• 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. PMID 34115661
• 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. PMID 21999576
• 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. PMID 36777368
• 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. PMID 36350998
• 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. PMID 24810138

Identifiers

NCT: NCT06696014 · 24-2191

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗