Early Proactive Therapeutic Drug Monitoring of Infliximab in Children: EPIC Study

• Status: Not yet recruiting
• Trial end date: 2025-01-31
• Target enrollment: 0
• Participant gender: All

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 and young adults with inflammatory bowel disease. Patients with an indication to receive IFX, based on current clinical practice recommendations, will receive the drug either based on IFX concentrations determined before every IFX infusion, starting from the third infusion, or at standard dosing. Approximately 90 patients will be included in this research study. Patients enrolled will be in the study for approximately 12 months.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS Burlo Garofolo
• Treatments: Infliximab

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