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Vedolizumab's Real-World impact on Crohn's disease explored

NCT ID NCT05192863

Knowledge-focused Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed observational study followed 72 adults with moderate to severe Crohn's disease who were starting vedolizumab treatment. The goal was to see if the drug could lead to complete remission—meaning no symptoms, normal inflammation markers, and healed bowel walls—after 12 months. Researchers used ultrasound to check bowel inflammation, alongside standard symptom scores and lab tests.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

72 people

The number who actually took part.

Started

Mar 2023

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Has moderately to severely active CD with a BWT of \>3 mm, based on IUS performed within the previous 4 weeks from baseline. 2. 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). Exclusion Criteria: 1. Prior history of intolerability, hypersensitivity to the active substance or to any of the excipients of vedolizumab. 2. Active severe infections such as tuberculosis (TB), sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as Progressive Multifocal Leukoencephalopathy (PML). 3. Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. 4. 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. 5. Ongoing or planned pregnancy or breastfeeding participants. 6. Active perforating complications or significant current strictures (assessed by IUS, with or without pre-stenotic dilatation) as per clinical judgement. 7. Characteristics precluding IUS visualization of affected bowel segments or normal BWT of \<=3 mm for all segments.

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn's disease

Contacts and locations

Locations

  • A.O.U. Federico II

    Naples, 80131, Italy

  • ASST Fatebenefratelli Sacco

    Milan, 20157, Italy

  • Fondazione Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • Hadassah Medical Center

    Jerusalem, 9112001, Israel

  • Ospedale ASST Rhodense

    Rho, Milano, 20017, Italy

  • Ospedale San Raffaele

    Milan, 20132, Italy

  • Rabin Medical Center

    Petah Tikva, 4941492, Israel

  • Sheba Medical Center

    Ramat Gan, 5262000, Israel

  • University of Calgary

    Calgary, Alberta, T2N 4N1, Canada

  • University of Saskatchewan

    Saskatoon, Saskatchewan, S7N 0W8, Canada

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