Proactive monitoring of Infliximab in children with inflammatory bowel disease
Impact of Early Proactive Therapeutic Drug Monitoring on the Durability and Efficacy of Infliximab Therapy in Pediatric Inflammatory Bowel Disease: a Multicenter Open-label Randomized-control Trial
This study is testing if adjusting the dose of Infliximab based on blood tests can help children and young adults with inflammatory bowel disease feel better and stay healthier.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Sponsor | IRCCS Burlo Garofolo Academic / other |
| Drugs / interventions | ustekinumab, vedolizumab, Infliximab |
| Locations | 1 site (Trieste) |
| Trial ID | NCT05280405 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of proactive therapeutic drug monitoring for Infliximab in children and young adults with inflammatory bowel disease (IBD). Participants will receive Infliximab based on drug concentration measurements taken before each infusion, starting from the third infusion, compared to standard dosing practices. The goal is to improve the drug's durability, efficacy, and safety by adjusting dosages according to individual patient needs. Approximately 90 patients aged 6 to 17 years will be enrolled and monitored for about 12 months.
Who should consider this trial
Good fit: Ideal candidates are anti-TNF naïve children and adolescents aged 6-17 years with a confirmed diagnosis of inflammatory bowel disease and active inflammation.
Not a fit: Patients with severe disease requiring surgery, recent infections, or previous exposure to anti-TNF therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment outcomes and reduce the risk of treatment failure in pediatric patients with IBD.
How similar studies have performed: Other studies have shown promise with proactive drug monitoring in adult populations, but this specific approach in children is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Trieste
- Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" — Trieste, Italy (Recruiting)
Study contacts
- Study coordinator: Sara Lega, MD PhD
- Email: sara.lega@burlo.trieste.it
- Phone: +390403785380
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.