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COMPARE - Pediatric Inflammatory Bowel Disease (PIBD)

Clinical Outcomes of Medications Post Anti-TNF: Researching Effectiveness in Pediatric IBD

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
1 Year to 18 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 years
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The surveys will collect information about the participants' general health and well-being while taking these medications."
  • "Clinical follow-up will occur in the context of routine care (e.g., clinic visits, telehealth encounters) for a minimum of 1-year and up to 3 years after the index date, regardless of whether the participant remains on the index treatment."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares how well newer medicines work and how safe they are for children with inflammatory bowel disease (IBD), which causes swelling in the digestive tract. It is for children whose anti-TNF medicines did not work or stopped working. Their regular care team will choose and manage their treatment, and children will answer questions about their symptoms and health during the study.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be younger than 18 when joining the study.
  • Have Crohn’s disease, ulcerative colitis, or unclassified IBD, as confirmed by standard tests. These are types of IBD.
  • Have tried at least one anti-TNF medicine, a type of IBD treatment, that did not work or stopped working.
  • Plan to start vedolizumab, ustekinumab, risankizumab, guselkumab, mirikizumab, tofacitinib, or upadacitinib. Generic versions and biosimilars (highly similar versions) are also allowed.
  • Have a parent give informed permission in English or Spanish. The child must also agree if local rules require it.

Who can't join

  • Plan to move care to a different center within 1 year.
  • Have used any of the listed study medicines before. You must be starting your first listed medicine on its own after anti-TNF treatment.
  • Have a medical reason that makes any of the study treatments unsafe for you.
  • Have ulcerative colitis or unclassified IBD and have had surgery to remove the colon (large intestine).
  • Currently have an ostomy, a surgically made opening in the belly for waste to leave the body.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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. * 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 or IBD-U who have undergone colectomy * Patients with current ostomy

Study sites (4)

NC

PA