NCT04921670

Infliximab Proactive Drug Monitoring in the Pediatric IBD Population

Active, enrolled Last updated 19 September 2024

What this trial tests

trial testing Infliximab Assay in Inflammatory Bone Disease in 60 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

12 March 2021

Primary endpoint
30 March 2025

30 August 2025

Quick facts

Lead sponsor	Cares, Kristen, M.D.
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	60
Start date	12 March 2021
Primary completion	30 March 2025
Estimated completion	30 August 2025
Sites	1 location across United States

Drugs / interventions tested

• Infliximab Assay

Conditions studied

• Inflammatory Bone Disease — all drugs for Inflammatory Bone Disease →

Sponsor

Cares, Kristen, M.D.

Who can join

Adults 5 to 21, any sex, with Inflammatory Bone Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Impact of Proactive Therapeutic Drug Monitoring on Infliximab Maintenance Therapy and Clinical Outcomes in Pediatric Inflammatory Bowel Disease: A Randomized Controlled Trial and Review of Literature.
   Cares K, Thomas R, Stolinski A, Parker J, et al · · 2026 · PMID 42125037 · DOI 10.1016/j.gastha.2026.100953