Therapeutic Drug Monitoring for Biological Therapy in Pediatric Inflammatory Bowel Disease (TDMpIBD)

April 24, 2025 updated by: Medical University Innsbruck

Therapeutic Drug Monitoring for Biological Therapy in Pediatric Inflammatory Bowel Disease: a Prospective Non-interventional Multicentric Study

Inflammatory Bowel Diseases (IBD), which include Crohn's disease (CD), ulcerative colitis (UC), and the unclassified form referred to as indeterminate colitis, are most commonly diagnosed during adolescence and early adulthood. In recent decades, an increasing incidence of IBD has been observed in this age group.

A wide range of immunomodulatory agents, from corticosteroids to monoclonal antibodies, are now available for the treatment of IBD. These antibodies, known as biologics, target, for example, tumor necrosis factor-alpha (TNF-α; e.g., infliximab and adalimumab), integrin α4β7 (vedolizumab), or interleukin-12/23 (ustekinumab). While infliximab and adalimumab are approved for pediatric use in CD and UC, vedolizumab is only approved for moderate-to-severe UC from the age of 16, and ustekinumab is not approved for pediatric use at all. Nevertheless, vedolizumab and ustekinumab are frequently used off-label in cases of treatment failure with approved therapies, as efficacy has been demonstrated in adult IBD patients, and since 2015, increasing pediatric literature has emerged on their use.

To facilitate appropriate dose adjustment in pediatric clinical practice, biologic therapies can be monitored through measurement of drug trough levels. Current pediatric guidelines already recommend incorporating therapeutic drug monitoring (TDM) of infliximab and adalimumab in the management of CD and UC. Studies on TDM for vedolizumab and ustekinumab have so far been conducted almost exclusively in adult IBD patients, where improved treatment responses have also been demonstrated.

The presented research is a prospective, non-interventional observational study involving pediatric IBD patients at multiple Austrian pediatric gastroenterology centers. The study duration is five years. The aim is to include at least 40 patients receiving induction and maintenance therapy with infliximab or adalimumab, and 20 patients treated with vedolizumab or ustekinumab during both treatment phases. The primary objective is to gain a better understanding of the pharmacokinetic dynamics of these biologics and the associated treatment response in pediatric settings. Data will be collected exclusively from routine clinical assessments. No additional study-related visits or interventions are planned.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Georg-Friedrich Vogel, Assoz. Prof. Dr. PhD
  • Phone Number: +43 (0)512/504-82184
  • Email: georg.vogel@i-med.ac.at

Study Locations

  • Austria
      • Feldkirch, Austria, 6800
      • Graz, Austria, 8036
      • Innsbruck, Austria, 6020
        • Recruiting
        • Medical University of Innsbruck
        • Contact:
      • Klagenfurt, Austria, 9020
      • Linz, Austria, 4020
      • Salzburg, Austria, 5020
        • Recruiting
        • Paracelsus Medizinische Privatuniversität
        • Contact:
      • Villach, Austria, 9500
      • Wien, Austria, 1090
      • Wien, Austria, 1090
      • Wien, Austria, 1220

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients with IBD under 18 years of age (Crohn's disease, ulcerative colitis, and IBD-unclassified) with Treatment withInfliximab, Adalimumab, Vedolizumab, or Ustekinumab during induction or maintenance phase.

Description

Inclusion Criteria:

  • Pediatric patients with an Inflammatory Bowel Disease (Crohn's disease, ulcerative colitis, and IBD-unclassified) being under 18 years of age
  • Treatment with Infliximab, Adalimumab, Vedolizumab, or Ustekinumab during induction or maintenance phase

Exclusion Criteria:

-- Patients with primary (congenital) immunodeficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Infliximab Group
those who receive Infliximab
Adalimumab Group
those who receive Adalimumab
Vedolizumab Group
those who receive Vedolizumab
Ustekinumab Group
those who receive Ustekinumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic Evaluation of Plasma Level of Biological Therapy
Time Frame: Plasma Levels will be assessed at Baseline and approximately at Weeks 2, 6, 14, 22, 30, 38, 46, and 54 during routine follow-up visits. Actual timing may vary slightly due to the non-interventional nature of the study.
Plasma levels of Infliximab, Adalimumab, Vedolizumab, and Ustekinumab will be assessed during routine follow-up visits, provided that such measurements are clinically indicated, in accordance with the non-interventional nature of the study design. The levels are measured in µg/ml.
Plasma Levels will be assessed at Baseline and approximately at Weeks 2, 6, 14, 22, 30, 38, 46, and 54 during routine follow-up visits. Actual timing may vary slightly due to the non-interventional nature of the study.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time Course of Disease Activity (clinical assessments)
Time Frame: Clinical outcome scores will be assessed at Baseline and approximately at Weeks 2, 6, 14, 22, 30, 38, 46, and 54 during routine follow-up visits. Actual timing may vary slightly due to the non-interventional nature of the study
Disease activity is assessed using validated clinical scoring systems. In patients with Crohn's disease, the weighted Pediatric Crohn's Disease Activity Index (wPCDAI) is applied, which ranges from 0 to 125 points; higher scores indicate increased disease activity. For patients with ulcerative colitis, the Pediatric Ulcerative Colitis Activity Index (PUCAI) is used, with a scoring range of 0 to 85 points-again, higher values reflect greater disease severity.
Clinical outcome scores will be assessed at Baseline and approximately at Weeks 2, 6, 14, 22, 30, 38, 46, and 54 during routine follow-up visits. Actual timing may vary slightly due to the non-interventional nature of the study
Time course of Disease Activity (laboratory assessments)
Time Frame: Calprotectin will be assessed at Baseline and approximately at Weeks 2, 6, 14, 22, 30, 38, 46, and 54 during routine follow-up visits. Actual timing may vary slightly due to the non-interventional nature of the study
Disease activity is assessed by measuring fecal calprotectin levels, a biomarker indicative of intestinal inflammation. Elevated levels correlate with increased disease activity. Calprotectin is quantified in µg/g of stool, with values below 20.0 µg/g considered within the normal range. Measurements are performed using a standardized assay in the routine clinical laboratory.
Calprotectin will be assessed at Baseline and approximately at Weeks 2, 6, 14, 22, 30, 38, 46, and 54 during routine follow-up visits. Actual timing may vary slightly due to the non-interventional nature of the study
Development of anti-drug antibodies during Biological Therapy
Time Frame: Anti-drug antibody Levels will be assessed at Baseline and approximately at Weeks 2, 6, 14, 22, 30, 38, 46, and 54 during routine follow-up visits. Actual timing may vary slightly due to the non-interventional nature of the study.
Each time plasma levels of Infliximab, Adalimumab, Vedolizumab, or Ustekinumab are measured, the same laboratory also assesses the presence of anti-drug antibodies. If detectable, these antibodies will be quantified and reported in ng/mL. The presence of elevated anti-drug antibody levels has been linked to reduced treatment efficacy and an increased risk of therapeutic failure. The probability of developing anti-drug antibodies is relatively low; therefore, multiple time points are assessed to ensure accurate detection and monitoring over the course of treatment.
Anti-drug antibody Levels will be assessed at Baseline and approximately at Weeks 2, 6, 14, 22, 30, 38, 46, and 54 during routine follow-up visits. Actual timing may vary slightly due to the non-interventional nature of the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University Innsbruck

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2025

Primary Completion (Estimated)

February 17, 2030

Study Completion (Estimated)

February 17, 2030

Study Registration Dates

First Submitted

April 7, 2025

First Submitted That Met QC Criteria

April 24, 2025

First Posted (Actual)

May 1, 2025

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDMpIBD (1126/2024)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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