Active — Not RecruitingNot Applicable

Infliximab Proactive Drug Monitoring in the Pediatric IBD Population

United States60 participantsStarted 2021-03-12

Plain-language summary

Inflammatory bowel disease (IBD) is a chronic condition that causes inflammation of the intestinal tract. Common types of IBD include Crohn's disease, ulcerative colitis, and indeterminate colitis. Infliximab (Remicade®) is a biologic medication that is approved by the U.S. Food and Drug Administration (FDA) for the treatment of IBD. Previous research with infliximab has shown it to be an effective treatment for pediatric IBD, however, it can become less effective if the level of the medication in the body is not high enough or if a patient develops antibodies (proteins made by the immune system that attack foreign substances in the body) to the medication. Currently, if a patient with IBD is taking infliximab and develops either abnormal lab values or reports a worsening of symptoms the doctors will measure the level of infliximab in the blood as well as any infliximab antibodies to determine if dosing changes, to either the dose of the medication or the frequency of dosing, are needed. This process is called reactive drug monitoring. The purpose of this research study is to find out if proactive drug monitoring in patients being treated with infliximab for IBD works better for controlling IBD. Proactive drug monitoring is measuring the level of infliximab in the blood as well as infliximab antibodies on a regular basis, before symptoms worsen or lab results come back abnormal, to see if dosing changes can be made that may prevent the worsening of IBD.

Who can participate

Age range5 Years – 21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients 5 years to 21 years of age, inclusive, with inflammatory bowel disease receiving infliximab therapy. * Patient or Parent/legal guardian has signed informed consent form and patient has provided written or oral assent (if applicable) * Patients who have completed the induction course of infliximab (treated for at least 14 weeks of infliximab) * Patients should be in stable clinical status. * Clinical status will be assessed by the treating physician and defined as symptom free (full responder) or clear clinical improvement, but clinical symptoms still present (partial responder). Concomitant immunomodulators are allowed, which may include medications like azathioprine, methotrexate, or oral corticosteroids at a low dose(defined as 0.5 mg/kg or ≤ 20 mg if subject weights above 40 kg) if kept stable throughout the study. Exclusion Criteria: * Patients younger than 5 years of age or older than 21 years of age. * Patients who are not on maintenance therapy of infliximab. * Patients who, at screening, have infliximab antibody levels greater than 1000 ng/mL, which was previously shown to be a clinically relevant cut-off. * Patients who fail to respond to infliximab. * Patients who are unable to complete the entire study. * Patients who have an antibody level \> 1000 ng/mL. * Patients who, in the opinion of the investigator, are unlikely to be able to complete the requirements of the study. * Failure to respond to current medical management…

What they're measuring

Number of relapses

Timeframe: 48 weeks

Trial details

NCT IDNCT04921670

SponsorCares, Kristen, M.D.

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-03-30