Infliximab level monitoring in children with inflammatory bowel disease
Single-center Pilot Study for Proactive Monitoring of Infliximab in Patients With Chronic Inflammatory Bowel Disease Starting Biologic Therapy: Comparative Assessment of Plasma and Salivary Levels
This project will test whether measuring infliximab levels in saliva and leftover blood during the first infusions helps monitor and personalize treatment for children and teens (ages 3–18) with Crohn's disease or ulcerative colitis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 3 Years to 18 Years |
| Sex | All |
| Sponsor | Meyer Children's Hospital IRCCS Academic / other |
| Drugs / interventions | infliximab |
| Locations | 1 site (Florence, Italy) |
| Trial ID | NCT07470502 on ClinicalTrials.gov |
What this trial studies
This is a monocentric, non-profit prospective cohort at Meyer Children's Hospital in Florence enrolling patients aged 3–18 with confirmed Crohn's disease or ulcerative colitis who are starting infliximab. During the first four infliximab infusions (three induction and one maintenance), two saliva samples (pre- and post-infusion) and one plasma sample (pre-infusion) will be collected at four routine clinical visits, using leftover blood from routine care so no extra blood draws are required. The induction regimen (standard or accelerated) is chosen by the treating physician and will not be influenced by study participation. Collected samples will be analyzed for infliximab levels to explore pharmacokinetic patterns during induction.
Who should consider this trial
Good fit: Children and adolescents aged 3–18 with confirmed Crohn's disease or ulcerative colitis who are about to start infliximab therapy and can provide consent/assent.
Not a fit: Patients who are not starting infliximab, lack a confirmed IBD diagnosis, refuse participation, or are outside the 3–18 age range are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, this could enable earlier, less invasive infliximab level monitoring to inform dosing decisions and reduce treatment failure in pediatric IBD.
How similar studies have performed: Plasma therapeutic drug monitoring for infliximab has demonstrated clinical utility in IBD, while saliva-based monitoring is an emerging approach with limited but growing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 3 and 18 years * diagnosis of Crohn's disease or ulcerative colitis * starting biological therapy with infliximab; * Signed informed consent. Exclusion Criteria: * Patients in whom the diagnosis of IBD has not been confirmed according to standardized endoscopic and histological criteria; * Patients who refuse to participate in the study.
Where this trial is running
Florence, Italy
- Meyer Children's Hospital, IRCCS - Gastroenterology and Nutrition Unit — Florence, Italy, Italy (Recruiting)
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.