NCT05192863

Brief Summary

The main aim of this study is to see if adults with CD treated with vedolizumab have less symptoms and inflammation of the bowel assessed by ultrasonography. Participants will be treated with vedolizumab according to their clinic's standard practice.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
3 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 14, 2022

Completed
1.2 years until next milestone

Study Start

First participant enrolled

March 20, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

November 13, 2025

Status Verified

November 1, 2025

Enrollment Period

2.6 years

First QC Date

January 11, 2022

Last Update Submit

November 12, 2025

Conditions

Crohn's Disease

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Who Achieve Complete Remission 12 Months After Initiation of Vedolizumab Therapy

    Complete remission will be measured by corticosteroid-free clinical, biochemical and transmural remission.Corticosteroid-free defined as no usage of any systemic or locally acting steroid.Corticosteroid-free clinical remission defined as Harvey Bradshaw Index (HBI) less than (\<) 5 points and no concomitant corticosteroids.HBI score measures disease activity of CD. Clinical parameters:general well-being (0-4,higher score lower well being),abdominal pain(0-3,higher score more severe pain),number of liquid stools/day, abdominal mass (0-3),higher score presence of swelling in abdomen),complications (score 1/item).Total is sum of individual parameters.Score:minimum 0-no pre-specified maximum score,depends on number of liquid stools, higher scores indicating more severe disease.Biochemical remission defined as C-reactive protein(CRP) and fecal calprotectin (FCal) normalization.Transmural remission defined as bowel wall thickness(BWT) of \<3 millimeter (mm) for all bowel segments upon IUS.

    Baseline up to 12 months

Secondary Outcomes (18)

  • Percentage of Participants Who Achieve Complete Remission

    Up to Month 18

  • Percentage of Participants Who Achieve Corticosteroid-free Clinical Remission

    Up to Month 18

  • Percentage of Participants Who Achieve Biochemical Remission

    Up to Month 18

  • Percentage of Participants Who Achieve Transmural Remission

    Up to Month 18

  • Percentage of Participants Who Achieve Clinical Response

    Up to Month 18

  • +13 more secondary outcomes

Study Arms (1)

Participants with CD

Participants diagnosed with moderately to severely active CD who are initiating vedolizumab intravenous (IV) induction treatment with the option to switch to vedolizumab subcutaneous (SC) treatment, as maintenance therapy in accordance with the current SmPC will be observed prospectively for 18 months.

Other: No Intervention

Interventions

No InterventionOTHER

This is a non-interventional study.

Participants with CD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult participants with moderately to severely active CD initiating vedolizumab therapy in a routine clinical care, with a BWT of \>3 mm, based on IUS assessment.

You may qualify if:

  • Has moderately to severely active CD with a BWT of \>3 mm, based on IUS performed within the previous 4 weeks from baseline.
  • Newly initiating IV vedolizumab induction treatment in accordance with the current SmPC either at enrolment or within 2 weeks after enrolment (switch to SC is acceptable at maintenance treatment stage).

You may not qualify if:

  • Prior history of intolerability, hypersensitivity to the active substance or to any of the excipients of vedolizumab.
  • Active severe infections such as tuberculosis (TB), sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as Progressive Multifocal Leukoencephalopathy (PML).
  • Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
  • Current or previous participation in an interventional clinical trial for CD within the past 30 days, or planned to be enrolled in an interventional clinical trial for CD.
  • Ongoing or planned pregnancy or breastfeeding participants.
  • Active perforating complications or significant current strictures (assessed by IUS, with or without pre-stenotic dilatation) as per clinical judgement.
  • Characteristics precluding IUS visualization of affected bowel segments or normal BWT of \<=3 mm for all segments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Hadassah Medical Center

Jerusalem, 9112001, Israel

Location

Rabin Medical Center

Petah Tikva, 4941492, Israel

Location

Sheba Medical Center

Ramat Gan, 5262000, Israel

Location

Ospedale ASST Rhodense

Rho, Milano, 20017, Italy

Location

Fondazione Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

ASST Fatebenefratelli Sacco

Milan, 20157, Italy

Location

A.O.U. Federico II

Napoli, 80131, Italy

Location

Related Links

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2022

First Posted

January 14, 2022

Study Start

March 20, 2023

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

November 13, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
More information

Locations

IT(5)CA(2)IL(3)