INSIGHT-IBD Pragmatic Study

Conditions

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

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Mirikizumab — DRUG
  Mirikizumab administered according to approved dosing regimens for ulcerative colitis and Crohn's disease.
• Anti-TNF agents — DRUG
  Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.
• anti-integrin antibodies — DRUG
  Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.
• IL-12 — DRUG
  Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.
• IL-23 — DRUG
  Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.

Study Details

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

Key Dates

First listed

Jul 7, 2026

Start date

Sep 30, 2026

Status verified

Aug 2026

Primary completion

Jun 30, 2028

Completion

Jun 30, 2028

Study Design

Enrollment

400 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Active Comparator: Mirikizumab Clinical Care Pathway
  Participants receive mirikizumab as part of the IBD Clinical Care Pathway in routine clinical practice. Dosing and administration follow the approved prescribing information for ulcerative colitis or Crohn's disease, with treatment and monitoring per standard of care.
• Active Comparator: Standard Biologic Therapy Clinical Care Pathway
  Participants receive standard biologic therapies for IBD as part of the IBD Clinical Care Pathway according to physician discretion and routine clinical practice. Therapies may include anti-TNF agents, anti-integrins, IL-12/23 antagonists, or IL-23p19 antagonists.

Primary Outcome Measure

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

Central Contacts

• Lorraine O'Donnell
  914-388-4907
  [email protected]
• Jessica Manzyuk

Locations (7)

Find similar trials in Sun City, AZ

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