Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Modellinformierte Präzisionsdosierung von Ustekinumab und Vedolizumab bei entzündlicher Darmerkrankung (MOVE-IT)

3. November 2026 aktualisiert von: Odense University Hospital

Modellbasierte Präzisionsdosierung (MIPD) von Ustekinumab und VEDolizumab bei entzündlichen Darmerkrankungen – eine unabhängige randomisierte kontrollierte Studie

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)

Studienübersicht

Status

Anmeldung auf Einladung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Patients will 4th weekly have their drug-concentration in blood measured (and if low, also antidrug antibodies). Hemoglobin, Albumin, CRP and white blood cell count will also be done, as well as a stool-sample for calprotectin measurement.

For the control group however, the clinicians and patients will be blinded for the results of the blood- and stool samples, and the samples for drug concentration will not get analyzed before end of study.

4th weekly they will also answer PRO2 questionnaire, as well as the VAS-F. 8th weekly they will in addition to above mentioned also answer the EQ-5D-5L questionnaire.

At inclusion, after 24 weeks, and at 48 weeks the patients will in addition to the above mentioned also answer the short IBDQ and WPAI questionnaires, as well as be seen in the outpatient clinic to obtain HBI or SCCAI score as applicable, as well as to document any changes in concomitant medication or diseases, and to register if any serious adverse events have presented.

At completion of the trial, patients will have a endoscopy done.

In one subprotocol, the investigators will include 20 patients from Odense to have an endoscopy at both inclusion and completion. Here they will also have biopsies taken from all segments of the colon, which will be stores in a biobank for future research.

In another subprotocol 20 patients will be included to have a intestinal ultrasound done at inclusion and completion.

In a biobank for future research the investigators will also store serum-samples, buffy coat, and stool samples collected at inclusion, after 24 and 48 weeks from all included patients.

Studientyp

Interventionell

Einschreibung (Geschätzt)

166

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Dänemark
      • Aalborg, Dänemark, 9000
        • Dept. of Gastrointestinal Diseases
      • Esbjerg, Dänemark, 6700
        • Dept. of Internal Medicin
      • Hvidovre, Dänemark, 2650
        • Dept. of Gastrointestinal Diseases
      • Nyborg, Dänemark, 5800
        • Dept. of medicine
      • Odense, Dänemark, 5000
        • Dept. of Gastrointestinal Diseases
      • Vejle, Dänemark, 7100
        • Dept. of Medicine

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Model-informed precision dosing of Vedolizumab/Ustekinumab

Patients will have blood- and stool samples collected, as well as date and time of drug administration every 4th week. All of these informations, in addition to some informations collected at inclusion, will be used in a PK-model to prescribe when the next dosage of drug should be administered to keep the patient in the therapeutic window.
Arzneimittel: 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.
Kein Eingriff: Dosing of Vedolizumab/Ustekinumab by physicians best clinical assessment

Patients will have blood- and stool samples collected every 4 weeks, but these will be blinded for the physicians. They are to be treated as regular patients, but will be seen every 24 weeks to collect clinical activity scores, register alterations in concomitant medication and possible serious adverse events.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The fraction of patients in steroid-free remission
Zeitfenster: 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)
at the end of the observation period (48 weeks)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The fraction of the observation period (48 weeks) where the disease is in steroid-free remission
Zeitfenster: 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.
this is registered every 4th week throughout the study duration of 48 weeks.
The financial costs associated with the two treatment strategies over the observation period (12 months)
Zeitfenster: 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.
through study completion, an average of 48 weeks
Endoscopic healing of the mucosa
Zeitfenster: 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
at completion of study, approximately 48 weeks
Changes in quality of life during the study period
Zeitfenster: 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.
48 weeks
Quality of life as QALYs
Zeitfenster: 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.
48 weeks
Clinical Disease Activity
Zeitfenster: 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.
48 weeks
Inflammatory burden over the observational period
Zeitfenster: 48 weeks

CRP, albumin, hemoglobin, leukocyte counts and fecal calprotectin. These will be collected every 4th week
48 weeks
Expenses for analysis of drug concentration
Zeitfenster: 48 weeks

patients will have drug concentrations analyzed every 4th week, the price of this will be collected
48 weeks
Expenses for drugs
Zeitfenster: 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
48 weeks
Drug persistency
Zeitfenster: 48 weeks

number of patients switching to another treatment during the study
48 weeks
Disease flares
Zeitfenster: 48 weeks

assessed by consumption of glucocorticoids or IBD-related surgery
48 weeks
Fatigue
Zeitfenster: 48 weeks.

to assess if treating according to a PK-model results in less fatigue measured by Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F). Patients are asked to register how fatigued they feel every 4th week throughout the study. The VAS-F is a visual analogue scale that goes from 0-10, 10 indicating severe fatigue.
48 weeks.
Disease impact on work productivity and performance of daily activities
Zeitfenster: 48 weeks

Assessed by difference in Work Productivity and Activity Impairment questionnaire (WPAI) scores and changes in scores between patients in the intervention- and control group. WPAI is collected at inclusion and every 24th week throughout the study.

WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
48 weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Odense University Hospital

Ermittler

  • Hauptermittler: Mark A Ainsworth, professor, DMSc, Odense University Hospital

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

23. Januar 2026

Primärer Abschluss (Geschätzt)

30. Dezember 2027

Studienabschluss (Geschätzt)

30. November 2028

Studienanmeldedaten

Zuerst eingereicht

7. Januar 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. Januar 2025

Zuerst gepostet (Tatsächlich)

23. Januar 2025

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. November 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 32844
  • 2024-517123-39-00 (Ctis)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

De-identified individual participant data will possibly be shared, including clinical characteristics, laboratory test results, and patient-reported outcomes relevant to the study endpoints.

Data will be available after publication of the main trial results and completion of any relevant follow-up studies. This is expected to occur approximately one year after the study's primary completion date.

Data will be available for a minimum of 5 years following the publication of the trial results.

IPD-Sharing-Zeitrahmen

will become available approximately March 2028 and will be available for at least 5 years

IPD-Sharing-Zugriffskriterien

Data will be shared with qualified researchers conducting legitimate scientific inquiries, particularly those working within the field of inflammatory bowel disease (IBD) and therapeutic drug monitoring (TDM)

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren