Monitoring the effectiveness of infliximab and adalimumab in treating inflammatory bowel diseases
Therapeutic Monitoring of Infliximab and Adalimumab in Pediatric Chronic Inflammatory Diseases: Innovative Pharmacological Strategies for Predicting Response and Adverse Effects
IRCCS Burlo Garofolo · NCT06033469
This study is testing if measuring the levels of two medications, infliximab and adalimumab, can help doctors better treat kids with inflammatory bowel diseases.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 1 Year to 17 Years |
| Sex | All |
| Sponsor | IRCCS Burlo Garofolo (other) |
| Drugs / interventions | infliximab, adalimumab |
| Locations | 3 sites (Bologna and 2 other locations) |
| Trial ID | NCT06033469 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the therapeutic monitoring of infliximab and adalimumab, two anti-TNF agents used to treat chronic inflammatory bowel diseases (IBD) in pediatric patients. The study aims to assess how measuring serum infliximab concentrations during induction therapy can predict treatment outcomes and improve patient responses. By utilizing new point-of-care devices that provide rapid results, the study seeks to optimize treatment adjustments and enhance clinical outcomes for patients who may not respond adequately to these therapies.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients aged 0 to 17 years diagnosed with inflammatory bowel diseases who are suitable for treatment with infliximab or adalimumab.
Not a fit: Patients who are not suitable for treatment with infliximab or adalimumab will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment responses and better management of inflammatory bowel diseases in pediatric patients.
How similar studies have performed: Previous studies have indicated that therapeutic monitoring of infliximab can predict treatment outcomes, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * IBD subjects * age between 0 and 17 years * suitable for treatment with infliximab or adalimumab Exclusion Criteria: * Pediatric subjects with IBD not suitable for treatment with infliximab or adalimumab
Where this trial is running
Bologna and 2 other locations
- Ospedale Maggiore — Bologna, Italy (RECRUITING)
- Ospedale Ca' Foncello — Treviso, Italy (RECRUITING)
- IRCCS Burlo Garofolo — Trieste, Italy (RECRUITING)
Study contacts
- Principal investigator: Gabriele Stocco, MSC — IRCCS materno infantile Burlo Garofolo
- Study coordinator: Giuliana Decorti, MD
- Email: giuliana.decorti@burlo.trieste.it
- Phone: +390403785111
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.
Conditions: Inflammatory Bowel Diseases, Infliximab, Adalimumab, Pharmacokinetics