Biomarkers predicting the effect of anti-TNF treatment in pediatric and adult inflammatory bowel disease.

Completed

• Conditions: Inflammatory Bowel Diseases; 10017969

• Registration Number: NL-OMON39856
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

- anti-TNF naïve CD patients (6 years and older) who initiate anti-TNF treatment (infliximab (IFX) or adalimumab (ADA)) because of active luminal disease, failing treatment with immunomodulators and corticosteroids
- anti-TNF naïve UC patients (6 years and older) who initiate anti-TNF treatment (IFX or ADA) because of active disease despite corticosteroid treatment or because of failing of immunomodulators treatment
- anti-TNF naïve CD or UC patients (6 years and older) who initiate anti-TNF treatment (IFX or ADA) because of intolerance to treatment with immunomodulators or corticosteroids

Exclusion Criteria

- IBD patients who initiate IFX or ADA immediately after diagnosis
- presence of severe perianal disease as primary indication to start anti-TNF treatment
- age younger then 6 years when anti-TNF maintenance treatment is initiated

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. pre-treatment serum level of endogenous anti-TNF in relation to initial<br /><br>response (= clinical remission) or non-response at week 8 in the two age<br /><br>groups.<br /><br>2. RNA expression profiles in relation to initial response (= clinical<br /><br>remission) or non-response at week 8 in the two age groups</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>N/A</p><br>