Testing computer-guided dosing of two drugs for inflammatory bowel disease
Tests computer-guided dosing of ustekinumab or vedolizumab in adults with inflammatory bowel disease.
Plain-language title generated from the registry record
Registry title: MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Key facts
- Where
- Aalborg, Esbjerg, Hvidovre, Nyborg, Odense C, and Vejle, DenmarkSee the 6 sites
- Phase
- Phase 4
Where in Denmark
- Aalborg University HospitalAalborg, DenmarkTaking people
- Esbjerg Og Grindsted SygehusEsbjerg, DenmarkTaking people
- Hvidovre HospitalHvidovre, DenmarkTaking people
- Odense University HospitalNyborg, DenmarkTaking people
- Odense University HospitalOdense C, DenmarkTaking people
- Sygehus Lillebaelt - Vejle SygehusVejle, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Odense University Hospital
- Trial code
- NCT06788340EU 2024-517123-39-00
- Record updated
- 6 November 2026
- Original description
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:Read full original descriptionShow less
MOdel-Informed Precision Dosing (MIPD) of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease - An Independent Randomized Controlled Trial
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)
Inclusion: Ulcerative colitis or Crohn's disease. Diagnosed, according to universally acknowledged criteria, a minimum of 3 months prior to inclusion; Age ≥ 18; Stable treatment with VDZ or UST for at least 3 months prior to inclusion; Stable disease activity, mild activity is accepted, defined by fecal calprotectin ≤ 200, and a weighted PRO2 < 14 for CD or a PRO2 ≤3 for UC; No change in medical therapy within 3 months prior to inclusion, as concomitant therapy with other immune suppressants is allowed (Azathioprine, 6-mercaptopurine, Methotrexate, 5-aminosalicylic acid); The patient must be able to understand patient information material; The patient must be able to give informed written consent.
Exclusion: Fistulizing disease being the primary reason for treatment with VDZ or UST; Expected eminent change of therapy; Expected need for surgical intervention within the coming 3 months; Contraindication against continuing treatment with VDZ or UST, including prior acute or delayed infusion reaction to VDZ or UST; Any active infection requiring parenteral treatment, known infection with tuberculosis, human immunodeficiency virus (HIV) or hepatitis virus; Any condition which the responsible physician finds incompatible with participation in the study; Having a diagnose of indeterminate colitis; Having a stoma or pouch; Patients unable to participate in the collection of symptoms scores; Patients who are pregnant or nursing at time of inclusion.