PK-model to decide when to dose Vedolizumab and Ustekinumab
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.
Study 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)
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* Having a diagnose of indeterminate colitis
* Having a stoma or pouch
* 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
* Patients unable to participate in the collection of symptoms scores
* Patients who are pregnant or nursing at time of inclusion
Primary outcome measure(s)
The fraction of patients in steroid-free remission — at the end of the observation period (48 weeks) ((for CD defined by PRO2 ≤ 4, for UC defined by PRO2 = 0) AND a fecal calprotectin ≤200)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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