Therapeutic Monitoring of Infliximab and Adalimumab

Sponsor
IRCCS Burlo Garofolo
Study ID
NCT06033469
Status
Unknown

Conditions

  • Inflammatory Bowel Diseases

Eligibility Criteria

Sex
ALL
Age
1 Year - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Infliximab — DRUG
    Pediatric patients with IBD suitable for treatment with infliximab
  • Adalimumab — DRUG
    Pediatric patients with IBD suitable for treatment with adalimumab

Study Details

Anti tumor necrosis factor (TNF agents), particularly infliximab and adalimumab, changed the way chronic inflammatory bowel disease (IBD) refractory to conventional therapies is treated, including in pediatric patients. However, approximately 10-30% of patients do not respond to initial therapy and up to 50% lose response over time. Variability in response to therapy may be influenced by multiple interacting factors at different levels. Recent studies showed that measurement of serum infliximab concentrations during induction therapy predicts treatment effects at one year. Therefore, therapeutic monitoring of infliximab is proposed as a useful strategy to improve clinical outcomes and optimize healthcare resources. Most commercially available methods for infliximab quantification are based on the ELISA assay, which has an assay time of at least 8 hours. Recently, commercial point-of-care devices became available with assay times of less than one hour, enabling real-time therapeutic drug monitoring; however, validation of these devices in clinical settings and comparison with standard assays are still needed, particularly in pediatric patients. In addition, some studies suggest that loss of response in patients treated with anti-TNFs may be partly due to the emergence of specific anti-drug antibodies (AAFs). A limitation of the most widely used ELISA assays is the inability to quantify drug and AAF when they are simultaneously present. Recently, innovative ELISA assays have become available to overcome this problem. However, there is a lack of comparative studies between the classical and the specific method in terms of clinical response in pediatric patients. In patients who do not respond to infliximab, especially if they have high levels of AAF, guidelines call for the use of adalimumab. For this drug, the evidence in the literature regarding therapeutic monitoring of adalimumab concentrations and association with response in pediatric patients is still very preliminary. This study, carried out in in pediatric patients with IBD, aims to: 1. validate the "point of care" infliximab assay by comparing it with reference ELISA assays; 2. evaluate the correlation of infliximab and AAF levels, as measured by the innovative ELISA assays, with response to therapy, compared to traditional assays. 3. evaluate the association between adalimumab and AAF levels and response to therapy

Key Dates

Start date
Mar 15, 2018
Status verified
Sep 2023
Primary completion
Jun 30, 2024
Completion
Jun 30, 2024

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: IBD group
    Pediatric patients with IBD

Primary Outcome Measure

Infliximab concentration [ Time Frame: Through study completion, an average of 5 years ]

Central Contacts

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