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

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Jeanne Tung, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Jeanne Tung, M.D.

Closed for enrollment

More information

Publications

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