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NCT04921670 · ClinicalTrials.gov registry record
Infliximab Proactive Drug Monitoring in the Pediatric IBD Population
A clinical trial of Inflammatory Bone Disease, sponsored by Cares, Kristen, M.D..
- Active
- Registry status
- 60
- Enrollment target
- 1
- Study location
NCT04921670 is a study of Inflammatory Bone Disease that is active but no longer recruiting, run by Cares, Kristen, M.D.. The registered enrollment target is 60 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04921670, a study of Inflammatory Bone Disease, is active but no longer recruiting, sponsored by Cares, Kristen, M.D..
- ACTIVE NOT RECRUITING
- Registry status
- 60 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- DIAGNOSTIC_TEST Infliximab Assay
Study Locations (1)
Michigan
- Children's Hospital of Michigan - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-03-12 |
| Est. Completion | 2025-08-30 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04921670
The ClinicalTrials.gov registry entry for NCT04921670 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cares, Kristen, M.D., which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Inflammatory Bone Disease appearing as the primary indexed condition, and to 1 intervention - of which Infliximab Assay is the first listed.
NCT04921670 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT04921670 about?
NCT04921670 is a clinical study titled "Infliximab Proactive Drug Monitoring in the Pediatric IBD Population". 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 Administrat...
What is the current status of trial NCT04921670?
This trial is currently active not recruiting. The enrollment target is 60 participants. The study started on 2021-03-12. Estimated completion is 2025-08-30.
What conditions does trial NCT04921670 study?
This clinical trial studies the following conditions: Inflammatory Bone Disease.
What interventions are being tested in trial NCT04921670?
The interventions under investigation include: Infliximab Assay (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04921670?
This trial is sponsored by Cares, Kristen, M.D., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04921670 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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