Идёт набор NCT06954311

Therapeutic Drug Monitoring for Biological Therapy in Pediatric Inflammatory Bowel Disease

— Наблюдательное Ulcerative Colitis (UC) IBD-unclassified (IBD-U)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Ulcerative Colitis (UC), IBD-unclassified (IBD-U). Базовые параметры: 0 лет — 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Австрия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Первичные конечные точки

Pharmacokinetic Evaluation of Plasma Level of Biological Therapy [Срок оценки: 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.]

Вторичные конечные точки (3)

Time Course of Disease Activity (clinical assessments) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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.]

Критерии участия

Критерии включения

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