Ulcerative Colitis (UC)TDMpIBDNCT06954311
Therapeutic Drug Monitoring for Biological Therapy in Pediatric Inflammatory Bowel Disease
An observational study of Ulcerative Colitis (UC) and IBD-unclassified (IBD-U), run by Medical University Innsbruck at 10 sites in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Ulcerative Colitis (UC), IBD-unclassified (IBD-U)
- How many people
- 120 participants
- Where
- 10 sitesAustria
- Study dates
- 17 Feb 2025to 17 Feb 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- -- Patients with primary (congenital) immunodeficiency
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Austria10 sites, 10 recruiting
- Recruiting
Landeskrankenhaus Feldkirch
Feldkirch, 6800
Doris Hanfstingl-Sinz, doris.hanfstingl@lkhf.at
- Recruiting
Universitätsklinikum Graz / Medizinische Universität Graz
Graz, 8036
Benno Kohlmaier, PD DDr., Sebastian.bauchinger@medunigraz.at
- Recruiting
Medical University of Innsbruck
Innsbruck, 6020
Georg-Friedrich Vogel, Assoz. Prof. Dr. PhD, +43 (0)512/504-82184, georg.vogel@i-med.ac.at
- Not yet recruiting
Klinikum Klagenfurt
Klagenfurt, 9020
Helga Stenzel, Dr., Helga.stenzel@kabeg.at
- Recruiting
Kepler Universitätsklinikum Linz
Linz, 4020
Elke Minichmayr, Dr.in, Elke.Minichmayr@kepleruniklinikum.at
- Recruiting
Paracelsus Medizinische Privatuniversität
Salzburg, 5020
Anna-Maria Schneider,, Dr.in, an.schneider@salk.at
- Recruiting
St. Anna Kinderspital
Vienna, 1090
Hubert Kogler, Dr., hubert.kogler@stanna.at
- Not yet recruiting
Universitätsklinik für Kinder- und Jugendheilkunde
Vienna, 1090
Judith Pichler, Doz. Dr., judith.pichler@meduniwien.ac.at
- Not yet recruiting
Klinik Donaustadt
Vienna, 1220
Christa Kuderna, Dr., christa.kuderna@gesundheitsverbund.at
- Recruiting
Landeskrankenhaus Villach
Villach, 9500
Robert Birnbacher, Univ.-Prof. Dr., robert.birnbacher@kabeg.at
About this study
Official title: 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.
Read more
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
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start17 Feb 2025
- Primary completion17 Feb 2030 (estimated)
- Study completion17 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954311
- Sponsor's protocol ID
- TDMpIBD (1126/2024)
- Acronym
- TDMpIBD
- Status last verified
- Mar 2025
- First submitted
- 7 Apr 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Drug Monitoring for Biological Therapy in Pediatric Inflammatory Bowel Disease: a Prospective Non-interventional Multicentric Study
- ClinicalTrials.gov ID
- NCT06954311
- Acronym / sponsor ID
- TDMpIBD / TDMpIBD (1126/2024)
- Conditions
- Ulcerative Colitis (UC), IBD-unclassified (IBD-U)
- Keywords
- IBD, Pediatric, Biologicals, Infliximab, Adalimumab, Vedolizumab, Ustekinumab
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 17 Feb 2030 (estimated)
- Study completion
- 17 Feb 2030 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Infliximab Group | – | –those who receive Infliximab |
| Adalimumab Group | – | –those who receive Adalimumab |
| Vedolizumab Group | – | –those who receive Vedolizumab |
| Ustekinumab Group | – | –those who receive Ustekinumab |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- -- Patients with primary (congenital) immunodeficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
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
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis (UC) and IBD-unclassified (IBD-U), run by Medical University Innsbruck at 10 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Georg-Friedrich Vogel, Assoz. Prof. Dr. PhD (+43 (0)512/504-82184, georg.vogel@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.