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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON39856

Enrollment

Registered

2013-10-03

Start date

2013-11-22

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases

Interventions

None listed

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. pre-treatment serum level of endogenous anti-TNF in relation to initial response (= clinical remission) or non-response at week 8 in the two age groups. 2. RNA expression profiles in relation to initial response (= clinical remission) or non-response at week 8 in the two age groups	—

Countries

Netherlands

Outcome results