A Study to Evaluate the Patterns of Use of Biological Agents and Risk Factors for Discontinuation of Agents in Pediatric Crohn’s Disease (CD) and Ulcerative Colitis (UC) within the Pediatric Population

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 16-008632
    Sponsor Protocol Number: 16-008632

About this study

The focus of this study is to retrospectively examine the patterns of use of biological agents and risk factors for discontinuation of these agents in pediatric Crohn’s disease (CD) and ulcerative colitis (UC) within the ICN network.  This will be a retrospective longitudinal observational cohort study.  The study population for the first portion of the study (Aim 1a below) will be all CD and UC patients in ICN who were diagnosed with IBD prior to age 18. This population will be queried for biologic use prior to age 18. The study population for the remainder of the study will be all CD and UC patients in ICN who received their first biologic medication before 18 years of age and who initiated therapy with the first biologic medication after registration in ICN.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Aim 1a:
    • Enrolled and consented in ImproveCareNow
    • Crohn’s disease or ulcerative colitis (not IC)
    • <18 years old at the time of IBD diagnosis.
  • Aims 1b-2:
    • Enrolled and consented in ImproveCareNow
    • Crohn’s disease or ulcerative colitis (not IC)
    • <18 years old at the time of IBD diagnosis.
    • <18 years old at the time of first treatment with a biological agent
    • First dose of a biological agent received after enrollment into ICN
    • Treatment with at least one dose of one biological agent
    • Documentation of date of initiation of each biological agent and date of discontinuation of each biological agent (if applicable). 

Exclusion Criteria:

  • No ICN consent
  • Age ≥18 at IBD diagnosis
  • Current diagnosis of Indeterminate Colitis (IC)

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Jeanne Tung, M.D.

Contact us for the latest status

Contact information:

Jeanne Tung M.D.

(507)266-0114