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MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Sponsor: Odense University Hospital
Summary
The goal of this clinical trial is to investigate if dosage of Ustekinumab (UST) and Vedolizumab (VDZ) based on Model-Informed Precision Dosing (MIPD) is equally as efficient in keeping adults with Inflammatory Bowel Disease (IBD) in remission as management based on what the treating physician deems best. The main question is: Is using pharmacokinetic-pharmacodynamic (PK-PD) models to predict the appropriate dose and dosing interval for VDZ and UST at least as effective as current practices in maintaining IBD remission. As above mentioned the comparison-group is adults with IBD, treated with UST or VDZ, managed as the physician deems best. Participants will: Have blood and stool tests done, as well as answer a questionnaire 4th weekly Have their dosage frequency decided on either by the PK-model or as the physician deems best visit the clinic once every 24 weeks for checkups. Have an endoscopy done at completion of the study (if the disease is primarily located in the small intestine, MRI or capsule endoscopy will be used instead)
Official title: MOdel-Informed Precision Dosing (MIPD) of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease - An Independent Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
166
Start Date
2025-09-01
Completion Date
2027-11-01
Last Updated
2025-07-31
Healthy Volunteers
No
Interventions
PK-model to decide when to dose Vedolizumab and Ustekinumab
the pharmacokinetic model will include information about inflammatory parameters both in blood- and fecal samples, as well as weight, sex, previous treatments and drug concentration.
Locations (6)
Dept. of Gastrointestinal Diseases
Aalborg, Denmark
Dept. of Internal Medicin
Esbjerg, Denmark
Dept. of Gastrointestinal Diseases
Hvidovre, Denmark
Dept. of medicine
Nyborg, Denmark
Dept. of Gastrointestinal Diseases
Odense, Denmark
Dept. of Medicine
Vejle, Denmark