COMPARE IBD

Currently Recruiting: Participants

Study Drug/Intervention: Observational Study

Anticipated Sample Size: 1,100 participants

Study Timeline: This study is expected to recruit through October 2028.

ClinicalTrials.gov ID: NCT07198113

What is COMPARE IBD?

The purpose of the study is to compare the clinical effectiveness and safety of newer inflammatory bowel disease (IBD) medications in anti-tumor necrosis factor (TNF) refractory patients with pediatric IBD (PIBD). COMPARE will consist of two multicenter, prospective observational cohorts (1 for patients with Crohn’s disease [CD] and 1 for patients with ulcerative colitis [UC] along with a retrospective cohort analysis focused on the long-term safety of these newer therapies.

Study Objective

Primary Objective: Compare the effectiveness of specific therapies to treat children with CD and UC refractory to anti-TNF therapy.

Secondary Objectives

1. Characterize the safety of specific therapies to treat children with CD and UC refractory to anti-TNF therapy.
2. Explore heterogeneity of treatment effects (HTE) across subgroups of clinical interest: age, time from diagnosis, baseline disease severity, number of prior anti-TNF therapies, and disease phenotype (Paris Classification).

Inclusion Criteria

• Age < 18 years at enrollment
• Diagnosis of CD or UC by standard diagnostic criteria
• Prior non-response or loss of response to one or more anti-TNF agents
• Planning to initiate treatment with any of the following comparator agents: vedolizumab (α4β7 integrin antibody), ustekinumab (anti-IL-12/23 antibody), risankizumab, guselkumab, or mirikizumab (IL-23 inhibitors), tofacitinib (JAK inhibitor), and upadacitinib (JAK inhibitor). Biosimilars or generic medications for any of the above will also be allowed and handled/analyzed in an identical manner to originators.
• Ability to provide child assent, if required per regulatory or local institutional guidelines, and parental informed consent in English or Spanish

Exclusion Criteria

• Plans to change care to a different center within 1 year
• Prior use of a comparator agent (i.e., only patients starting their first comparator medication as monotherapy following anti-TNF will be eligible)
• Contraindication to any of the treatments under investigation
• Patients with UC who have undergone colectomy
• Patients with a current ostomy

We plan to enroll approximately 550 participants with CD and 550 with UC whose disease is refractory to anti-TNF therapy. The retrospective cohort analysis will include a limited data set extracted from the electronic health record (EHR) for up to 30,000 patients across study sites.

Study Sites

For a list of active recruiting centers, please visit ClinicalTrials.gov NCT07198113

Duration of Study Participation

1-3 years

Participant Follow-Up

Participants will complete electronic patient reported outcomes measures.

PCORI

COMPARE IBD study email: COMPARE@duke.edu