Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT05280405
Eligibility Criteria:
Inclusion Criteria:
1. Anti-TNF naïve children and adolescents, 6-17 years, with a diagnosis of IBD confirmed by a prior endoscopic biopsy that is consistent with the diagnosis
2. Indication to start anti-TNF therapy in accordance with current pediatric guidelines for the treatment of pediatric IBD
3. Active inflammation supported by CRP \> 5mg/L and /or FC \> 150 μg/g before the 1st IFX dose
Exclusion Criteria:
1. Consent withdrawal,
2. Stenosing or penetrating disease requiring surgery, abdominal abscess, symptomatic stricture,
3. Abdominal surgery within the previous 6 months,
4. Acute severe ulcerative colitis attack defined by a PUCAI score Ñ 65,
5. Infective contraindication to IFX treatment including positive tuberculin skin test or Quantiferon-TB test, recent opportunistic infection, infection with hepatitis B (HBV), C (HCV), human immunodeficiency virus (HIV),
6. Previous exposure to anti-TNF;
7. Exposure to concomitant prohibited medications including other biologics (including but not limited to ustekinumab, vedolizumab, abatacept, anakinra..), thalidomide, investigational drugs
8. Pregnancy or lactation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT05280405
Study Brief:
Protocol Section:
NCT05280405