Therapeutic Drug Monitoring for Biological Therapy in Pediatric Inflammatory Bowel Disease

NCT06954311 | Recruiting

• 1 other identifier: TDMpIBD (1126/2024)
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Ulcerative Colitis (UC); IBD-unclassified (IBD-U)

Keywords

IBD; Pediatric; Biologicals; Infliximab; Adalimumab; Vedolizumab; Ustekinumab

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic Evaluation of Plasma Level of Biological Therapy

  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 Outcomes (3)

• Time Course of Disease Activity (clinical assessments)

  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)

  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

  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.

Study Arms (4)

Infliximab Group

those who receive Infliximab

Adalimumab Group

those who receive Adalimumab

Vedolizumab Group

those who receive Vedolizumab

Ustekinumab Group

those who receive Ustekinumab

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \-- Patients with primary (congenital) immunodeficiency

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (10)

Landeskrankenhaus Feldkirch

Feldkirch, 6800, Austria

RECRUITING

Universitätsklinikum Graz / Medizinische Universität Graz

Graz, 8036, Austria

RECRUITING

Medical University of Innsbruck

Innsbruck, 6020, Austria

RECRUITING

Klinikum Klagenfurt

Klagenfurt, 9020, Austria

NOT YET RECRUITING

Kepler Universitätsklinikum Linz

Linz, 4020, Austria

RECRUITING

Paracelsus Medizinische Privatuniversität

Salzburg, 5020, Austria

RECRUITING

St. Anna Kinderspital

Vienna, 1090, Austria

RECRUITING

Universitätsklinik für Kinder- und Jugendheilkunde

Vienna, 1090, Austria

NOT YET RECRUITING

Klinik Donaustadt

Vienna, 1220, Austria

NOT YET RECRUITING

Landeskrankenhaus Villach

Villach, 9500, Austria

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Georg-Friedrich Vogel, Assoz. Prof. Dr. PhD

CONTACT

+43 (0)512/504-82184; georg.vogel@i-med.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: May 1, 2025
• Study Start: February 17, 2025
• Primary Completion (Estimated): February 17, 2030
• Study Completion (Estimated): February 17, 2030
• Last Updated: May 1, 2025

Record last verified: 2025-03

Locations

AU (10)