INSIGHT-IBD Pragmatic Study

Summary

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

Conditions

• Ulcerative Colitis (UC)
• Crohn Disease (CD)

Interventions

DRUG

Mirikizumab

Mirikizumab administered according to approved dosing regimens for ulcerative colitis and Crohn's disease.

DRUG

Anti-TNF agents

Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.

DRUG

anti-integrin antibodies

Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.

DRUG

IL-12

Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.

DRUG

IL-23

Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.

Sponsors & Collaborators

• Eli Lilly and Company

  collaborator INDUSTRY

• Specialty Networks Research.

  lead NETWORK

Principal Investigators

• Casey Chapman, MD · GIA

• Nicholas Lazarou, MPH, MBA · Cardinal Health

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-12

Primary Completion

2028-06-30

Completion

2028-06-30

FDA Drug

Yes

Countries

• United States

Study Locations