Inflammatory Bowel Disease (IBD)VARIETYNCT05384080
A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Poland
An observational study of Inflammatory Bowel Disease (IBD) and Crohn's Disease, run by Takeda at 11 sites in Poland.
Trial summary
The primary reason of this study is to observe current treatment options in participants receiving Vedolizumab, intravenous (IV) or subcutaneous (SC), for IBD in Poland. There is no treatment involved in this study, this is only an observational review of ongoing/initiating treatment data relating to Vedolizumab… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease (IBD), Crohn's Disease, Ulcerative Colitis
- Type of treatment
- Injection or infusion
- How many people
- 165 participants
- Where
- 11 sitesPoland
- Study dates
- 8 Aug 2022to 13 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with moderately to severely active UC or CD receiving vedolizumab treatment in accordance with the approved SmPC and NDP.
Who may be able to join
- 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.
Who cannot join
- 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.
- Current or planned participation in an interventional clinical trial for CD or UC.
- Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- .
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Poland11 sites
Szpital Uniwersytecki Nr 2 Im. Dr Jana Biziela W Bydgoszczy
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168
Szpital Uniwersytecki w Krakowie
Krakow, Lesser Poland Voivodeship, 30-688
Spzoz Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego
Lodz, Łódź Voivodeship, 90-153
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie
Lublin, Lublin Voivodeship, 20-954
Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Miedzychodzie
Międzychód, Greater Poland Voivodeship, 64-400
Szpital Kliniczny Im. Heliodora Swiecickiego Uniwersytetu Medycznego Im. Karola Marcinkowskiego W Poznaniu
Poznan, Greater Poland Voivodeship, 60-335
HT Centrum Medyczne
Tychy, Slskie, 43-100
Centralny Szpital Kliniczny MSWiA w Warszawie
Warsaw, Masovian Voivodeship, 02-507
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie
Warsaw, Masovian Voivodeship, 02-781
Wojskowy Instytut Medyczny
Warsaw, Masovian Voivodeship, 04-141
Uniwersytecki Szpital Kliniczny
Wroclaw, Dolnoslskie, 50-556
About this study
Official title: Prospective, Non-interventional, Observational Study in Patients With IBD Receiving IV or SC Vedolizumab Therapy to Observe Route of Administration Choices and Outcomes (VARIETY-POLAND)
The primary reason of this study is to observe current treatment options in participants receiving Vedolizumab, intravenous (IV) or subcutaneous (SC), for IBD in Poland. There is no treatment involved in this study, this is only an observational review of ongoing/initiating treatment data relating to Vedolizumab induction and maintenance treatment for IBD [including Ulcerative Colitis (UC) and Crohn's Disease (CD)].
Read the detailed description
This is a non-interventional, prospective study of participants with moderately to severely active IBD (UC or CD) who are initiating or currently ongoing induction or maintenance treatment with vedolizumab in the real world setting.
The study will enroll approximately 160 participants: 100 participants with UC and 60 participants with CD. The data will be collected prospectively at the study sites and will be recorded into electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort:
•Participants with IBD
This single center study will be conducted in Poland at public hospitals and institutions that treat UC and CD. The overall duration of the study will be at least 24 months. Data will be collected at baseline, every 3 months within the first year and every 6 months within the second year, and at the time of switch, discontinuation and/or at routine follow-up visits.
- Keywords
- Drug Therapy
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants With IBD | Participants diagnosed with moderately to severely active IBD (UC or CD) who are currently ongoing vedolizumab IV induction treatment in accordance with the current Summary of Product Characteristics (SmPC) and National Drug Program (NDP) at baseline or receiving vedolizumab ongoing or maintenance IV treatment with the option to switch to vedolizumab SC treatment, will be observed prospectively for 24 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Persisting on Treatment With Vedolizumab IV Compared to Participants With Treatment Change up to 24 Months
Measured: Baseline up to 24 months
Time to any Treatment Change
Measured: Baseline up to 24 months
Number of Participants Who Discontinued Vedolizumab Treatment
Measured: Baseline up to 24 months
Number of Participants With Reason for Treatment Change
Measured: Baseline up to 24 months
Number of Participants With Change in Vedolizumab Dosing Frequency
Measured: Baseline up to 24 months
Number of Participants Who Changed to Another Treatment
Measured: Baseline up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start8 Aug 2022
- Primary completion13 Jun 2025
- Study completion13 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384080
- Sponsor's protocol ID
- VedolizumabSC-4004
- Acronym
- VARIETY
- Status last verified
- Apr 2026
- First submitted
- 17 May 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-interventional, Observational Study in Patients With IBD Receiving IV or SC Vedolizumab Therapy to Observe Route of Administration Choices and Outcomes (VARIETY-POLAND)
- ClinicalTrials.gov ID
- NCT05384080
- Acronym / sponsor ID
- VARIETY / VedolizumabSC-4004
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 13 Jun 2025 (actual)
- Study completion
- 13 Jun 2025 (actual)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary reason of this study is to observe current treatment options in participants receiving Vedolizumab, intravenous (IV) or subcutaneous (SC), for IBD in Poland. There is no treatment involved in this study, this is only an observational review of ongoing/initiating treatment data relating to Vedolizumab induction and maintenance treatment for IBD [including Ulcerative Colitis (UC) and Crohn's Disease (CD)].
Detailed description
This is a non-interventional, prospective study of participants with moderately to severely active IBD (UC or CD) who are initiating or currently ongoing induction or maintenance treatment with vedolizumab in the real world setting.
The study will enroll approximately 160 participants: 100 participants with UC and 60 participants with CD. The data will be collected prospectively at the study sites and will be recorded into electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort:
•Participants with IBD
This single center study will be conducted in Poland at public hospitals and institutions that treat UC and CD. The overall duration of the study will be at least 24 months. Data will be collected at baseline, every 3 months within the first year and every 6 months within the second year, and at the time of switch, discontinuation and/or at routine follow-up visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants With IBD | – | –Participants diagnosed with moderately to severely active IBD (UC or CD) who are currently ongoing vedolizumab IV induction treatment in accordance with the current Summary of Product Characteristics (SmPC) and National Drug Program (NDP) at baseline or receiving vedolizumab ongoing or maintenance IV treatment with the option to switch to vedolizumab SC treatment, will be observed prospectively for 24 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with moderately to severely active UC or CD receiving vedolizumab treatment in accordance with the approved SmPC and NDP.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
- Current or planned participation in an interventional clinical trial for CD or UC.
- Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants Persisting on Treatment With Vedolizumab IV Compared to Participants With Treatment Change up to 24 Months
Time frame: Baseline up to 24 months
Time to any Treatment Change
Time frame: Baseline up to 24 months
Number of Participants Who Discontinued Vedolizumab Treatment
Time frame: Baseline up to 24 months
Number of Participants With Reason for Treatment Change
Time frame: Baseline up to 24 months
Number of Participants With Change in Vedolizumab Dosing Frequency
Time frame: Baseline up to 24 months
Number of Participants Who Changed to Another Treatment
Time frame: Baseline up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Click here for more information about this trial in easy-to-understand language.Link provided by the sponsor.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease (IBD) and Crohn's Disease, run by Takeda at 11 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Persisting on Treatment With Vedolizumab IV Compared to Participants With Treatment Change up to 24 Months (time frame: Baseline up to 24 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.