COMPARE - Pediatric Inflammatory Bowel Disease (PIBD)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorUniversity of North Carolina, Chapel Hill
About this trial
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). Refractory means that there was no clinical response to anti-tumor necrosis factor (TNF) drugs or that the if there was a response, it is no longer present. The main question this study aims to answer is:
Are the newer medications used to treat IBD just as safe and effective for treating IBD in children.
Participants will already be taking these newer medications as assigned by their regular health care provider.Participants' care will be managed by their regular healthcare provider as part of usual (standard) care for those with PIBD. While taking these medications, participants will be asked to answer questions about their symptoms and health periodically over the course of the study.
Eligibility criteria
Qualifiers
Age < 18 years at study enrollment
Diagnosis of CD, UC, or IBD-U 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.
Disqualifiers
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 or IBD-U who have undergone colectomy
Trial design
Treatments tested in this trial
- Not listed
Trial groups
1,100 Participants
are grouped into 3 trial groupsSponsors and collaborators
University of North Carolina, Chapel Hill
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Duke Clinical Research Institute
Collaborator
Source ClinicalTrials.gov