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Real-World study tracks how IBD patients choose between IV and injectable vedolizumab

NCT ID NCT04989907

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study observed 92 adults with Crohn's disease or ulcerative colitis who were receiving vedolizumab either as an intravenous infusion or a subcutaneous injection. Researchers tracked treatment patterns, such as whether patients stayed on their current form or switched, over 12 months. The goal was to understand real-world choices and outcomes without influencing how patients were treated.

What this could mean

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

Active substance
vedolizumab
What this could lead to
If successful, this study could help doctors and patients make more informed decisions about which form of vedolizumab (IV or injection) works best in daily life.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by patient or doctor preferences rather than the treatment itself.

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

92 people

The number who actually took part.

Started

Sep 2021

Finished

May 2024

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 UC or CD receiving vedolizumab treatment in accordance with the approved SmPC.

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 IBD (UC or CD), initiating or ongoing IV induction treatment with vedolizumab in accordance with the current SmPC at baseline OR IBD participants receiving ongoing/maintenance IV vedolizumab treatment, with the option to switch to SC vedolizumab maintenance treatment. Exclusion Criteria: 1. Prior history of intolerability, hypersensitivity, or other contraindications (active severe infections such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as Progressive Multifocal Leukoencephalopathy) to vedolizumab therapy as defined in the current SmPC. 2. Current or planned participation in an interventional clinical trial for CD or UC. 3. Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

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

Colitis ulcerative Crohns disease Inflammatory bowel diseases

Contacts and locations

Locations

  • Bauchzentrum INSELSPITAL, Universitatsspital Bern

    Bern, 3010, Switzerland

  • Clarunis AG

    Basel, 4002, Switzerland

  • Gastroenterologische Praxis Balsiger, Seibold & Partner Crohn-Colitis-Zentrum

    Bern, 3012, Switzerland

  • Kantonsspital St. Gallen

    Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

  • Universitatsspital Zurich

    Zurich, 8091, Switzerland

  • Zentrum fur Gastroenterologie und Hepatologie AG

    Zurich, 8048, Switzerland

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