Prospective Analysis of Pharmacokinetic Infliximab data in Paediatric Inflammatory Bowel Disease patients

Phase 4

• Conditions: Crohn's disease; Inflammatory bowel disease; 10017969

• Registration Number: NL-OMON51805
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 49

Inclusion Criteria

Diagnosed with Crohn's disease, age 1-15, anti-TNF naive, indication to start
Infliximab

Exclusion Criteria

Established monogenetic disease, perianal/fistulizing disease, severe
comorbidity (not related to IBD)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Proportion of patients with IFX TL >= 5 µg/mL at week 12 without treatment<br /><br>escalation. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Proportion of patients with IFX TL >= 5 µg/mL at week 24 without the need for<br /><br>treatment escalation<br /><br>• Clinical and biochemical remission at weeks 4, 12, and 24 without the need<br /><br>for treatment escalation in patients with TL >= 5 µg/mL and in patients with TL<br /><br>< 5 µg/mL<br /><br>• Predictors of IFX TLs at weeks 4, 12, and 24. Factors included in this<br /><br>analysis will be sex, age, body mass index (BMI), wPCDAI, IBD laboratory<br /><br>values, ATI, dose, and interval of IFX infusions<br /><br>• Development of ATI until week 24<br /><br>• Prediction of patients who will respond vs. those who will not despite<br /><br>adequate TLs at weeks 12 and 24 based on proteomics analysis by OLINK<br /><br>• Evaluation of quality of life at baseline, week 12, and 24 in all patients<br /><br>• Adverse event rate over time</p><br>