Move-It

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Odense University Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

15 Dec 2025 → ongoing

Decision date (initial)

2025-04-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Pharmacokinetic, Therapy

To investigate if dosage of Vedolizumab (VDZ) and Ustekinumab (UST) based on Therapeutic Drug Monitoring (TDM) is equally as efficient in keeping Inflammatory Bowel Diseases (IBD) in remission as management based on what the treating physician deems best.

Secondary objectives 11

1. Determine if it is cost-effective to treat in a TDM-manner when treating with vedolizumab and ustekinumab
2. To assess whether treating according to a PK-model is better at attaining mucosal healing versus symptom driven treatment
3. To assess if treating according to the PK-model results in better life quality than management based on what the treating physician deems best
4. To assess if treating according to the PK-model results in better life quality than management based on what the treating physician deems best, and what the price of each QALY is.
5. To compare whether treating according to the PK-model is better at attaining clinician-assessed clinical remission versus management based on what the physician deems best.
6. To assess whether there is biochemical disease control during the study in both patients treated according to the PK-model and management based on what the physician deems best.
7. To determine if it is cost-effective to treat in a TDM-manner when it comes to treatment with Vedolizumab and Ustekinumab.
8. To assess drug persistency
9. To assess if patients experience flareups during the study period, defined as surgery or use of glucocorticoids.
10. To assess if patients experience relief of fatigue when treated according to PK-model predictions compared to management based on what the physician deems best
11. To assess if treating according to PK-model predictions lead to less work impairment, higher work productivity and better performance of daily activities comparted to management based on what the physician deems best.

Conditions and MedDRA coding

crohns disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Ulcerative colitis or Crohn’s disease. Diagnosed, according to universally acknowledged criteria, a minimum of 3 months prior to inclusion
2. Age ≥ 18
3. Stable treatment with VDZ or UST for at least 3 months prior to inclusion
4. Stable disease activity with no change in medical therapy within 3 months prior to inclusion. Mild disease activity, defined defined by fecal calprotectin ≤ 200, and a weighted PRO2 < 14 for CD or a PRO2 ≤3 for UC is allowed.
5. 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-aminosaliclyic acid)
6. The patient must be able to understand patient information material
7. The patient must be able to give informed written consent

Exclusion criteria 10

1. Having a diagnose of indeterminate colitis
2. Having a stoma or pouch
3. Fistulizing disease being the primary reason for treatment with VDZ or UST
4. Expected eminent change of therapy
5. Expected need for surgical intervention within the coming 3 months
6. Contraindication against continuing treatment with VDZ or UST, including prior acute or delayed infusion reaction to VDZ or UST
7. Any active infection requiring parenteral treatment, known infection with tuberculosis, human immunodeficiency virus (HIV) or hepatitis virus.
8. Any condition which the responsible physician finds incompatible with participation in the study
9. Patients unable to participate in the collection of symptoms scores
10. Patients who are pregnant or nursing at time of inclusion

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The fraction of patients in steroid-free remission ((for CD defined by PRO2 ≤ 4, for UC defined by PRO2 = 0) AND a fecal calprotectin ≤200) at the end of the observation period (48 weeks).

Secondary endpoints 13

1. The fraction of the observation period (48 weeks) where the disease is in steroid-free remission (for CD defined by PRO2 ≤ 4, for UC defined by PRO2 = 0) AND a fecal calprotectin ≤200.
2. The financial costs associated with the two treatment strategies over the observation period (48 weeks), including 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.
3. Endoscopic healing of the mucosa assessed after 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 or Lewis score, respectively.
4. Quality of life assessed by SIBDQ at inclusion and end of treatment.
5. Quality of life assessed by EQ-5D-5L and transferred to QALY. The price of QALYs will also be measured.
6. The portion of the observational period wherein the patient’s disease is in clinical remission, assessed as the portion of the observational period in which the disease is in steroid-free remission according to Simplified Clinical Activity Index (SCCAI) for ulcerative colitis and Harvey-Bradshaw Index (HBI) for Crohn’s disease.
7. The inflammatory burden during the observational period, assessed by CRP, albumin, hemoglobin, leukocyte-measurements and fecal-calprotectin.
8. Drug concentration analysis expenses.
9. Drug expenses
10. The proportion of patients switching to another drug during the study period.
11. Consumption of steroids, defined as redeemed prescriptions from the apothecary. Surgery related to IBD.
12. Fatigue assessed by VAS-F difference between patients in the intervention and control group
13. The diseases impact on work productivity and performance of daily activities assessed by difference in WPAI scores and changes in scores between patients in the intervention and control group

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Odense University Hospital

Sponsor organisation

Odense University Hospital

Address

J B Winsloews Vej 4

City

Odense C

Postcode

5000

Country

Denmark

Scientific contact point

Organisation

Odense University Hospital

Contact name

Mark Andrew Ainsworth

Public contact point

Organisation

Odense University Hospital

Contact name

Mark Andrew Ainsworth

Third parties 1

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 27 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications