Mirikizumab Real World Protocol

University of North Carolina, Chapel Hill6 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Ulcerative Colitis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (9)

South Denver Gastroenterology

Denver, Colorado, United States

AdventHealth

Orlando, Florida, United States

University of Iowa Health Care

Iowa City, Iowa, United States

University of Louisville, Clinical Trials Unit

Outcomes

Primary Outcomes

induction of clinical response as evaluated by the Simple Clinical Colitis Activity Index (SCCAI) for the patient-reported outcomes.

The SCCAI is a 6-item that describes the symptoms and disease activity of a patient with UC at the time of assessment. A score of 0-4 is considered a clinical range of remission (but with more refined definitions of clinical remission with SCCAI ≤2 and very mild symptoms with a score \>2 ≤4), 5-7 mild activity, 8-16 moderate activity and \> 16 severe activity. A response will be defined as a decrease of the SCCAI score \< 5 points in patients with a baseline SCCAI ≥5.

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 Outcomes

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)

Description: PROMIS measure of depression measures well-being. This is calculated as T scores. A clinically meaningful difference is considered to be a change in T score of ≥ 2.5 (scores are normalized at 50 with a standard deviation of 10). Differences in PROMIS scores compared to baseline will be assessed.

Time frame: Weeks 0, 12, 24, and 52.

Remission as measured by PROMIS-Anxiety Score

PROMIS measure of anxiety measures well-being. This is calculated as T scores. A clinically meaningful difference is considered to be a change in T score of ≥ 2.5 (scores are normalized at 50 with a standard deviation of 10). Differences in PROMIS scores compared to baseline will be assessed.

Time frame: Weeks 0, 12, 24, and 52

Remission as measured by PROMIS-Sleep Score

PROMIS measure of sleep measures well-being. This is calculated as T scores. A clinically meaningful difference is considered to be a change in T score of ≥ 2.5 (scores are normalized at 50 with a standard deviation of 10). Differences in PROMIS scores compared to baseline will be assessed.

Data from ClinicalTrials.gov

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