Mirikizumab compared with standard biologic treatment in ulcerative colitis and Crohn's disease
Compares mirikizumab with standard biologics in adults with ulcerative colitis or Crohn's disease.
Plain-language title generated from the registry record
Registry title: INSIGHT-IBD Pragmatic Study
Key facts
- Where
- Cedar Park, Fort Worth, Glenview, Gurnee, Houston, Indianapolis, Plano, Richmond, Rochester, San Antonio, San Marcos, Sun City, and Tucson, United StatesSee the 13 sites
- Phase
- Phase 4
Where in United States
- Texas Digestive Disease ConsultantsCedar Park, United StatesNo longer taking part
- Texas Digestive Disease ConsultantsFort Worth, United StatesNo longer taking part
- GI Alliance of IllinoisGlenview, United StatesNo longer taking part
- Lake Shore Gastro-Gurnee ResearchGurnee, United StatesNo longer taking part
- Digestive Health AssociatesHouston, United StatesNo longer taking part
- Indianapolis Gastroenterology & HepatologyIndianapolis, United StatesNo longer taking part
- Texas Digestive Disease Consultants: PlanoPlano, United StatesNo longer taking part
- GI Alliance RichmondRichmond, United StatesNo longer taking part
- Gastroenterology Group of RochesterRochester, United StatesNo longer taking part
- Texas Digestive Disease Consultants: San AntonioSan Antonio, United StatesNo longer taking part
- Texas Digestive Disease Consultants - San MarcosSan Marcos, United StatesNo longer taking part
- Arizona Digestive HealthSun City, United StatesNo longer taking part
- AZ Digestive Health-TucsonTucson, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Specialty Networks Research.
- Trial code
- NCT07686757
- Record updated
- 29 October 2026
- Original description
The goal of this study is to evaluate the real-world effectiveness of treatments for inflammatory bowel disease (IBD) within routine clinical practice.Read full original descriptionShow less
INSIGHT-IBD Pragmatic Study: Investigation of Mirikizumab in Real World Settings for Mirikizumab
The goal of this study is to evaluate the real-world effectiveness of treatments for inflammatory bowel disease (IBD) within routine clinical practice.
The study population includes adult patients (≥21 years) with ulcerative colitis (UC) or Crohn's disease (CD) receiving care in community gastroenterology practices in the United States.
The main questions it aims to answer are:
* Does treatment with mirikizumab reduce the proportion of patients requiring an increase in IBD disease management (e.g., unplanned visits, dose escalation, therapy switch, emergency department visits, or hospitalization)? * Does treatment with mirikizumab improve clinical outcomes, including disease activity, clinical remission, and patient-reported outcomes, compared to standard biologic therapy? * Researchers will compare patients treated with mirikizumab within the IBD Clinical Care Pathway versus patients receiving standard biologic therapies to see if mirikizumab leads to improved disease control and reduced healthcare utilization.
Participants will:
* Receive either mirikizumab or standard biologic therapy as part of routine clinical care * Attend follow-up visits at approximately 3, 6, 12, and 18 months * Have clinical data collected from electronic health records and healthcare utilization sources * Complete patient-reported outcome questionnaires assessing symptoms, quality of life, and daily functioning * Undergo routine laboratory tests and clinical assessments as part of standard care
Inclusion: Age ≥21 years at the time of enrollment; Confirmed diagnosis of ulcerative colitis (UC) or Crohn's disease (CD); Eligible for treatment with biologic therapy for IBD, as per the IBD Clinical Care Pathway; No prior exposure to mirikizumab and no contraindications to mirikizumab; Ability to provide informed consent; Willingness to comply with study procedures and follow-up requirements.
Exclusion: Prior exposure to IL-23p19 antagonists (e.g., mirikizumab, risankizumab, guselkumab); Prior exposure to small molecule targeted therapies for IBD (e.g., JAK inhibitors or S1P receptor modulators); Participation in an interventional clinical trial within 90 days prior to enrollment; Surgical removal of two or more intestinal segments (for CD); History of extensive colorectal resection, including:; Any condition that, in the investigator's judgment, may compromise patient safety, data integrity, or ability to participate in the study; Total proctocolectomy (for UC), or.