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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 \[including Ulcerative Colitis (UC) and Crohn's Disease (CD)\].
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Uniwersytecki Szpital Kliniczny
Wroclaw, Dolnoslskie, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Miedzychodzie
Międzychód, Greater Poland Voivodeship, Poland
Szpital Kliniczny Im. Heliodora Swiecickiego Uniwersytetu Medycznego Im. Karola Marcinkowskiego W Poznaniu
Poznan, Greater Poland Voivodeship, Poland
Szpital Uniwersytecki Nr 2 Im. Dr Jana Biziela W Bydgoszczy
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Szpital Uniwersytecki w Krakowie
Krakow, Lesser Poland Voivodeship, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie
Lublin, Lublin Voivodeship, Poland
Centralny Szpital Kliniczny MSWiA w Warszawie
Warsaw, Masovian Voivodeship, Poland
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie
Warsaw, Masovian Voivodeship, Poland
Wojskowy Instytut Medyczny
Warsaw, Masovian Voivodeship, Poland
HT Centrum Medyczne
Tychy, Slskie, Poland
Start Date
August 8, 2022
Primary Completion Date
June 13, 2025
Completion Date
June 13, 2025
Last Updated
September 2, 2025
165
ACTUAL participants
Lead Sponsor
Takeda
NCT06226883
NCT07271069
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06975722