INSIGHT-IBD Pragmatic Study

Part of paid clinical trials in Sun City, Arizona.

Sponsor
Specialty Networks Research.
Study ID
NCT07686757
Phase
PHASE4
Status
Enrolling By Invitation

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
Aug 12, 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 ]

Locations (10)

FacilityCityStateZIPSite coordinators
Arizona Digestive HealthSun CityArizona85351-
GI Alliance of IllinoisGlenviewIllinois60005-
Lake Shore Gastro-Gurnee ResearchGurneeIllinois60031-
Gastroenterology Group of RochesterRochesterNew York14618-
Texas Digestive Disease ConsultantsCedar ParkTexas78613-
Texas Digestive Disease ConsultantsFort WorthTexas76104-
Digestive Health AssociatesHoustonTexas77024-
Texas Digestive Disease Consultants: PlanoPlanoTexas75093-
Texas Digestive Disease Consultants: San AntonioSan AntonioTexas78215-
GI Alliance RichmondRichmondVirginia23229-

Find similar trials in Sun City, AZ

By research site
Arizona Digestive Health· Sun City, AZGI Alliance of Illinois· Glenview, ILLake Shore Gastro-Gurnee Research· Gurnee, ILGastroenterology Group of Rochester· Rochester, NYTexas Digestive Disease Consultants· Cedar Park, TXTexas Digestive Disease Consultants· Fort Worth, TX

Related Studies