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Infliximab Proactive Drug Monitoring in the Pediatric IBD Population

NCT04921670 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Inflammatory Bone Disease

Interventions

DIAGNOSTIC_TEST

Infliximab Assay

Participants will be assigned to standard of care or proactive drug monitoring, which is measuring infliximab levels/antibodies before every infusion

Sponsors & Collaborators

  • Cares, Kristen, M.D.

    lead OTHER

Eligibility

Min Age
5 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-12
Primary Completion
2025-03-30
Completion
2025-08-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04921670 on ClinicalTrials.gov