Infliximab Proactive Drug Monitoring in the Pediatric IBD Population

NCT04921670 | Active Not Recruiting FDA Drug

• 1 other identifier: INFLIXIMAB-2019
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of relapses

  The of relapses in each group (defined as need for rescue treatment, either with steroids or additional immunomodulator, or increased infliximab dose) after completing the maintenance phase of the study.

  48 weeks

Study Arms (2)

Group A-Standard monitoring group (Reactive drug monitoring)

Participants assigned to this group will be managed the same as normally done per routine care, which involves adjusting their infliximab dose and/or dosing interval based on Inflammatory Bowel Disease (IBD) symptoms and routine care laboratory test results. The primary gastroenterologist will not be given the results of the infliximab and infliximab antibody level results of participants in this group unless their routine laboratory test results or IBD symptoms suggest their IBD may be worsening.

• Group B- Infliximab level and infliximab antibody monitoring group (Proactive drug monitoring)

Participants assigned to the infliximab level and infliximab antibody level monitoring group will be managed based on the infliximab level and infliximab antibody level results as well as their IBD symptoms and the results of routine care laboratory tests. The goal is to keep infliximab levels in the optimal range with little to no antibodies. The primary gastroenterologist will remain blinded to the results of the infliximab level/infliximab antibody level test results and the participants' dose will be adjusted by one of the other study doctors who is not blinded to the results.

Diagnostic Test: Infliximab Assay

Interventions

Infliximab Assay DIAGNOSTIC_TEST

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

• Group B- Infliximab level and infliximab antibody monitoring group (Proactive drug monitoring)

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children ages 5 to 21 years of age with inflammatory bowel disease receiving infliximab therapy

You may qualify if:

• 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.

You may not qualify if:

• 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 based on clinical assessment.

Sponsors & Collaborators

• Cares, Kristen, M.D.: lead

Study Sites (1)

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Osteitis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: June 10, 2021
• Study Start: March 12, 2021
• Primary Completion: March 30, 2025
• Study Completion: August 30, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)