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Researchers watch how IBD patients pick their vedolizumab shot or drip

NCT ID NCT05384080

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study observed 165 people with inflammatory bowel disease (Crohn's or ulcerative colitis) in Poland who were already taking or starting vedolizumab. Researchers tracked whether patients chose intravenous or subcutaneous (under-the-skin) injections, and how long they stayed on treatment. No new treatment was given—it simply watched real-world choices and outcomes over 24 months.

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

165 people

The number who actually took part.

Started

Aug 2022

Finished

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

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.Participants with moderately to severely active IBD (UC or CD), initiating or ongoing IV induction treatment with vedolizumab in accordance with the current SmPC and National Drug Program (NDP) 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.

Crohn's disease Inflammatory bowel disease (IBD) Ulcerative colitis

Contacts and locations

Locations

  • Centralny Szpital Kliniczny MSWiA w Warszawie

    Warsaw, Masovian Voivodeship, 02-507, Poland

  • Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • HT Centrum Medyczne

    Tychy, Slskie, 43-100, Poland

  • Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie

    Lublin, Lublin Voivodeship, 20-954, Poland

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Miedzychodzie

    Międzychód, Greater Poland Voivodeship, 64-400, Poland

  • Spzoz Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego

    Lodz, Łódź Voivodeship, 90-153, Poland

  • Szpital Kliniczny Im. Heliodora Swiecickiego Uniwersytetu Medycznego Im. Karola Marcinkowskiego W Poznaniu

    Poznan, Greater Poland Voivodeship, 60-335, Poland

  • Szpital Uniwersytecki Nr 2 Im. Dr Jana Biziela W Bydgoszczy

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, Poland

  • Szpital Uniwersytecki w Krakowie

    Krakow, Lesser Poland Voivodeship, 30-688, Poland

  • Uniwersytecki Szpital Kliniczny

    Wroclaw, Dolnoslskie, 50-556, Poland

  • Wojskowy Instytut Medyczny

    Warsaw, Masovian Voivodeship, 04-141, Poland

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