MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease

Launched by ODENSE UNIVERSITY HOSPITAL · Jan 22, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how to best manage dosages of two medications, Ustekinumab (UST) and Vedolizumab (VDZ), for adults with Inflammatory Bowel Disease (IBD), which includes conditions like Crohn's disease and ulcerative colitis. The researchers want to see if using a special approach called Model-Informed Precision Dosing (MIPD) can keep patients in remission just as effectively as the traditional method, where doctors decide the best dose based on their experience.

To participate in the trial, you need to be at least 18 years old and have been diagnosed with ulcerative colitis or Crohn’s disease for at least three months. You should be stable on your current treatment with either UST or VDZ for the same period. Participants will have regular check-ups every 24 weeks, along with blood and stool tests to monitor their condition, and they will answer some questionnaires to provide feedback about their health. At the end of the study, an endoscopy may be conducted to assess the disease further. This trial is currently not recruiting participants, but it aims to find out if a more precise dosing method can help manage IBD effectively.

Gender

ALL

Eligibility criteria

• 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