Viewing Study NCT04921670



Ignite Creation Date: 2024-05-06 @ 4:15 PM
Last Modification Date: 2024-10-26 @ 2:06 PM
Study NCT ID: NCT04921670
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2023-03-09
First Post: 2021-05-20

Brief Title: Infliximab Proactive Drug Monitoring in the Pediatric IBD Population
Sponsor: Cares Kristen MD
Organization: Cares Kristen MD

Study Overview

Official Title: Infliximab Proactive Drug Monitoring in the Pediatric IBD Population
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Inflammatory bowel disease IBD is a chronic condition that causes inflammation of the intestinal tract Common types of IBD include Crohns disease ulcerative colitis and indeterminate colitis Infliximab Remicade is a biologic medication that is approved by the US 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
Detailed Description: Inflammatory bowel disease IBD is a chronic condition that leads to an inflammatory reaction in the intestinal tract

Common subtypes of IBD include Crohns disease ulcerative colitis and less often indeterminate colitis Symptoms of IBD vary from mild abdominal pain to profound diarrhea weight loss and significant anemia due to intestinal blood loss

Infliximab is a biologic drug that is FDA approved for the treatment of Crohns disease and ulcerative colitis in children 6 years of age or older Infliximab is administered as an intravenous infusion with weight-based dosing 5mgkg and a regimen that includes an induction phase week 0 2 6 followed by maintenance phase every 8 weeks Unfortunately research indicates that more than half of all pediatric patients lose the initial response of biologic therapy and require either a higher dose additional therapy with an immunomodulatory like steroids or need to be switched to a different biologic drug Loss of response can be due to increased clearance of drug with or without the development of antibody to the drug Lab tests are now being used to measure the level of infliximab and the presence of anti-infliximab antibody AIA as it is now known that the pharmacokinetics how a drug is processed by the body of infliximab varies between patients Previous research has shown a relationship between infliximab and antibody levels and clinical response In general low infliximab levels with or without the development of antibodies are associated with worse clinical outcomes Currently these lab tests are used in the clinical setting reactively called therapeutic drug monitoring TDM In other words if a patient starts showing signs of relapse return of abdominal pain diarrhea or worsening laboratory markers while on infliximab infliximab and antibody levels are obtained to assess for loss of response eg low infliximab level or development of antibodies If the infliximab level is low with or without antibodies often physicians can increase the dose of medication or frequency of the medication to treat the relapse This has been shown to be effective and led to sustained clinical response in a number of studies Unfortunately if the antibody level is at an extremely high level the window for changing the dose or frequency of dosing might be missed and the patient may need to be switched to a different biologic medication completely

Reactive TDM has been recommended in clinical practice but proactive TDM has yet to be implemented due to limited knowledge In theory by proactively obtaining infliximab and antibody levels ie measuring at a pre-specified time instead of waiting until the patient develops symptoms or lab results show a loss of response physicians may have the opportunity to prevent loss of response thus to make changes in the treatment regimen before a patient shows clinical signs of relapse or requires transitioning to a different biologic medication This is especially important in the pediatric population as IBD can be more aggressive in addition to affecting growth bone development and puberty In addition by proactively monitoring there is a potential safety benefit In patients with extremely high infliximab levels a reduction in the drug may prevent adverse events In addition to safety reduction in the drug dose or frequency can relieve some of the burden of cost

Research in adult studies has reported a significant cost reduction by performing TDM with a predetermined infliximab goal level

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: True
Is an FDA AA801 Violation?: None