Status:
UNKNOWN
Early Proactive Therapeutic Drug Monitoring of Infliximab in Children: EPIC Study
Lead Sponsor:
IRCCS Burlo Garofolo
Conditions:
Inflammatory Bowel Diseases
Eligibility:
All Genders
6-17 years
Phase:
PHASE4
Brief Summary
The purpose of the study is to assess whether a proactive therapeutic drug monitoring strategy, introduced early during treatment, improves Infliximab (IFX) durability, efficacy and safety in children...
Detailed Description
Inflammatory Bowel Disease (IBD) are relapsing disorders with progressive bowel damage leading to long-term disability. Infliximab (IFX), is a highly effective and commonly used biologic in IBD. Howe...
Eligibility Criteria
Inclusion
- 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
- Indication to start anti-TNF therapy in accordance with current pediatric guidelines for the treatment of pediatric IBD
- Active inflammation supported by CRP \> 5mg/L and /or FC \> 150 μg/g before the 1st IFX dose
Exclusion
- Consent withdrawal,
- Stenosing or penetrating disease requiring surgery, abdominal abscess, symptomatic stricture,
- Abdominal surgery within the previous 6 months,
- Acute severe ulcerative colitis attack defined by a PUCAI score Ñ 65,
- 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),
- Previous exposure to anti-TNF;
- Exposure to concomitant prohibited medications including other biologics (including but not limited to ustekinumab, vedolizumab, abatacept, anakinra..), thalidomide, investigational drugs
- Pregnancy or lactation
Key Trial Info
Start Date :
March 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2025
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT05280405
Start Date
March 9 2022
End Date
January 31 2025
Last Update
August 18 2023
Active Locations (1)
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1
Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
Trieste, Italy, 34137