Infliximab Proactive Drug Monitoring in the Pediatric IBD Population
- Conditions
- Inflammatory Bone Disease
- Registration Number
- NCT04921670
- Lead Sponsor
- Cares, Kristen, M.D.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria:<br><br> - Patients 5 years to 21 years of age, inclusive, with inflammatory bowel disease<br> receiving infliximab therapy.<br><br> - Patient or Parent/legal guardian has signed informed consent form and patient has<br> provided written or oral assent (if applicable)<br><br> - Patients who have completed the induction course of infliximab (treated for at least<br> 14 weeks of infliximab)<br><br> - Patients should be in stable clinical status.<br><br> - Clinical status will be assessed by the treating physician and defined as<br> symptom free (full responder) or clear clinical improvement, but clinical<br> symptoms still present (partial responder). Concomitant immunomodulators are<br> allowed, which may include medications like azathioprine, methotrexate, or oral<br> corticosteroids at a low dose(defined as 0.5 mg/kg or = 20 mg if subject<br> weights above 40 kg) if kept stable throughout the study.<br><br>Exclusion Criteria:<br><br> - Patients younger than 5 years of age or older than 21 years of age.<br><br> - Patients who are not on maintenance therapy of infliximab.<br><br> - Patients who, at screening, have infliximab antibody levels greater than 1000 ng/mL,<br> which was previously shown to be a clinically relevant cut-off.<br><br> - Patients who fail to respond to infliximab.<br><br> - Patients who are unable to complete the entire study.<br><br> - Patients who have an antibody level > 1000 ng/mL.<br><br> - Patients who, in the opinion of the investigator, are unlikely to be able to<br> complete the requirements of the study.<br><br> - Failure to respond to current medical management based on clinical assessment.
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of relapses
- Secondary Outcome Measures
Name Time Method