Trial · NCT06788340
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
NCT06788340, Phase 4, Enrolling by invitation, Odense University Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease. Trials, record NCT06788340. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06788340
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
- NCT number
- NCT06788340
- Status
- Enrolling by invitation
- Phases
- Phase 4
- Enrollment
- 166 participants, estimated
- Lead sponsor
- Odense University Hospital
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- Interventions
- PK-model to decide when to dose Vedolizumab and Ustekinumab
- First posted
- 2025-01-23
- Last updated
- 2026-11-06
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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) |
| Secondary | The fraction of the observation period (48 weeks) where the disease is in steroid-free remission | this is registered every 4th week throughout the study duration of 48 weeks. | for CD defined by patient reported outcome 2 (PRO2) stool frequency \<= 3 and abdominal pain \< = 1, for UC defined by PRO2, number of abnormal stools for the patient, bleeding from the rectum = 0) AND a fecal calprotectin ≤ 200. |
| Secondary | The financial costs associated with the two treatment strategies over the observation period (12 months) | through study completion, an average of 48 weeks | expenditure on medicines (both expenditure on the purchase of medicines and expenditure on the administration of medicines), expenses for doctor visits / visits to a nurse, possibly expenses for hospitalization, possibly expenses for surgery, possibly expenses for sick leave and possibly expenses for early retirement. After end of study, the investigators will collect data on sick leave etc. from the national patient registry. |
| Secondary | Endoscopic healing of the mucosa | at completion of study, approximately 48 weeks | for CD assessed by Simple Endoscopic Score for Crohn's Disease (SES-CD) \<3; and for UC assessed on the basis of the Ulcerative Colitis Endoscopic Index of Severity (UCEIS)≤1. If disease is primarily located in the small intestine, MRI or capsule endoscopy will be used instead, and assessed by the simplified MaRIA score \<1 or Lewis score ≤135, respectively |
| Secondary | Changes in quality of life during the study period | 48 weeks | assessed by Short Inflammatory Bowel Disease Questionnaire (SIBDQ) difference between baseline and end of study. Improvement of quality of life indicated by a positive change of the SIBDQ. SIBDQ is collected at inclusion, week 24 and week 48. A higher the score, indicates a better outcome, Maksimum score of 70 points. |
| Secondary | Quality of life as QALYs | 48 weeks | assessed by the EuroQol-5 dimensions-5 levels questionnaire (EQ-5D-5L) and converted to QALYs. The cost per QALY will also be calculated. EQ-5D-5L is collected every 8th week throughout the study. Score ranges from 5-25, a higher score indicating poorer quality of life. |
| Secondary | Clinical Disease Activity | 48 weeks | assessed by Simplified Clinical Colitis Activity Index (SCCAI) for UC and Harvey-Bradshaw Index (HBI) for CD. These are collected at inclusion and every 24th week thereafter. SCCAI score ranges from 0-19, a higher score indicating a more severe disease activity. HBI score ranges from 0-20, a higher score indicating more severe disease activity. |
| Secondary | Inflammatory burden over the observational period | 48 weeks | CRP, albumin, hemoglobin, leukocyte counts and fecal calprotectin. These will be collected every 4th week |
| Secondary | Expenses for analysis of drug concentration | 48 weeks | patients will have drug concentrations analyzed every 4th week, the price of this will be collected |
| Secondary | Expenses for drugs | 48 weeks | patients will typically administer sc VDZ every 4th to 2nd week, iv VDZ every 12th to 4th week and UST every 12th to 4th week |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41453773 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06788340
GET https://conductscience.org/api/trials/v1/NCT06788340/registered