NCT05384080Completed
A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Poland
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)
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
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 \[including Ulcerative Colitis (UC) and Crohn's Disease (CD)\].
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 165 (actual)
- First submitted
- 17 May 2022
- Start date
- 8 Aug 2022
- Primary completion date
- 13 Jun 2025
- Lead sponsor
- Takeda
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT05384080
What you commit to
- Study type: Observational
- Participants enrolled: 165
- From 8 Aug 2022 to the primary completion date, 13 Jun 2025
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- Current or planned participation in an interventional clinical trial for CD or UC.
- Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- .
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Unknown status |
| Szpital Uniwersytecki w Krakowie Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
| Spzoz Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego Coordinator of this site? Confirm its status | Lodz | Poland | Unknown status |
| Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Coordinator of this site? Confirm its status | Lublin | Poland | Unknown status |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Miedzychodzie Coordinator of this site? Confirm its status | Międzychód | Poland | Unknown status |
| Szpital Kliniczny Im. Heliodora Swiecickiego Uniwersytetu Medycznego Im. Karola Marcinkowskiego W Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Unknown status |
| HT Centrum Medyczne Coordinator of this site? Confirm its status | Tychy | Poland | Unknown status |
| Wojskowy Instytut Medyczny Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Centralny Szpital Kliniczny MSWiA w Warszawie Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Centrum Onkologii Instytut im.Marii Sklodowskiej-Curie Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Uniwersytecki Szpital Kliniczny Coordinator of this site? Confirm its status | Wroclaw | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.