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New study tracks Real-World use of entyvio in over 1,100 ulcerative colitis patients

NCT ID NCT03824561

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This completed study looked at the long-term safety and effectiveness of vedolizumab (Entyvio) in over 1,100 people with moderate to severe ulcerative colitis who had not responded well to other treatments. Researchers tracked side effects and how well the drug controlled disease activity in everyday medical practice. The goal was to see how the drug performs outside of strict clinical trial settings.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vedolizumab (Entyvio)
What this could lead to
If successful, this confirms vedolizumab as a safe and effective long-term option for controlling moderate to severe ulcerative colitis.
What could go wrong
This is an observational surveillance study, not a controlled trial, so results may be less definitive. Side effects are possible, and not all patients may respond.

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

1,110 people

The number who actually took part.

Started

Feb 2019

Finished

Feb 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

UC patients treated with vedolizumab for IV infusion 300 mg as part of routine medical care

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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. Have moderate or severe active UC 2. Have inadequate response to existing therapies Exclusion Criteria: Patients with any contraindication for vedolizumab

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

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

Ulcerative colitis

Contacts and locations

Locations

  • Takeda Selected Site

    Tokyo, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.