INSIGHT-IBD Pragmatic Study

Official title

INSIGHT-IBD Pragmatic Study: Investigation of Mirikizumab in Real World Settings for Mirikizumab

Overview

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

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.

Primary outcome measures

• Proportion of Patients Requiring an Increase in IBD Disease Management [Time frame: Up to 18 months following initiation of therapy]

Secondary outcome measures (12)

• Change in Disease Activity Measured by Crohn's Disease PRO2 Scores [Time frame: Baseline, 6 months, 12 months, and 18 months]
• Change in Disease Activity Measured by Ulcerative Colitis PRO2 Scores [Time frame: Baseline, 6 months, 12 months, and 18 months]
• Proportion of Participants Achieving Endoscopic Remission Measured by Simple Endoscopic Score for Crohn's Disease (SES-CD) [Time frame: Up to 18 months (as available from routine clinical care)]
• Proportion of Participants Achieving Endoscopic Remission Measured by Modified Baron Score. [Time frame: Up to 18 months (as available from routine clinical care)]
• Treatment Persistence [Time frame: Up to 18 months]
• Proportion of Patients with Dose Escalation [Time frame: Up to 18 months]
• Time to Next Treatment [Time frame: Up to 18 months]
• Concomitant Medication Use [Time frame: Baseline through 18 months]
• Corticosteroid-Free Time [Time frame: Up to 18 months]
• Healthcare Resource Utilization [Time frame: Up to 18 months]
• Change in Patient-Reported Outcomes Measured by SIBDQ [Time frame: Baseline, 6 months, 12 months, and 18 months]
• Change in Patient-Reported Outcomes Measured by UNRS [Time frame: Baseline, 6 months, 12 months, and 18 months]

Eligibility criteria

Inclusion criteria

• 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, defined as failure of prior conventional therapy and/or prior biologic therapy (excluding IL-23p19 antagonists)
• 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 criteria

• 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
• History of extensive colorectal resection, including:
• Total proctocolectomy (for UC), or
• Surgical removal of two or more intestinal segments (for CD)
• Any condition that, in the investigator's judgment, may compromise patient safety, data integrity, or ability to participate in the study

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

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 7 centers

• Arizona Digestive Health — Sun City
• GI Alliance of Illinois — Glenview
• Gastroenterology Group of Rochester — Rochester
• Texas Digestive Disease Consultants — Cedar Park
• Texas Digestive Disease Consultants — Fort Worth
• Digestive Health Associates — Houston
• GI Alliance Richmond — Richmond

Identifiers

NCT: NCT07686757 · 103899

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗