A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Poland (VARIETY)

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)].

Study Overview

• Status: Completed
• Conditions: Crohn's Disease; Ulcerative Colitis; Inflammatory Bowel Disease (IBD)

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 Type: Observational
• Enrollment (Actual): 165

Contacts and Locations

Study Locations

• Poland
  • Dolnoslskie
    • Wroclaw, Dolnoslskie, Poland, 50-556
      • Uniwersytecki Szpital Kliniczny
  • Greater Poland Voivodeship
    • Międzychód, Greater Poland Voivodeship, Poland, 64-400
      • Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Miedzychodzie
    • Poznan, Greater Poland Voivodeship, Poland, 60-335
      • Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
  • Kuyavian-Pomeranian Voivodeship
    • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-168
      • Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-688
      • Szpital Uniwersytecki w Krakowie
  • Lublin Voivodeship
    • Lublin, Lublin Voivodeship, Poland, 20-954
      • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-507
      • Centralny Szpital Kliniczny MSWiA w Warszawie
    • Warsaw, Masovian Voivodeship, Poland, 02-781
      • Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie
    • Warsaw, Masovian Voivodeship, Poland, 04-141
      • Wojskowy Instytut Medyczny
  • Slskie
    • Tychy, Slskie, Poland, 43-100
      • HT Centrum Medyczne
  • Łódź Voivodeship
    • Lodz, Łódź Voivodeship, Poland, 90-153
      • Spzoz Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult participants with moderately to severely active UC or CD receiving vedolizumab treatment in accordance with the approved SmPC and NDP.

Description

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.

   .

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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 the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to any Treatment Change	Baseline up to 24 months
Number of Participants With Reason for Treatment Change	Baseline up to 24 months
Number of Participants With Change in Vedolizumab Dosing Frequency	Baseline up to 24 months
Number of Participants Who Changed to Another Treatment	Baseline up to 24 months
Percentage of Participants Persisting on Treatment With Vedolizumab IV Compared to Participants With Treatment Change up to 24 Months	Baseline up to 24 months
Number of Participants Who Discontinued Vedolizumab Treatment	Baseline up to 24 months

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

• 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.
• Click here for more information about this trial in easy-to-understand language.

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2022
• Primary Completion (Actual): June 13, 2025
• Study Completion (Actual): June 13, 2025

Study Registration Dates

• First Submitted: May 17, 2022
• First Submitted That Met QC Criteria: May 17, 2022
• First Posted (Actual): May 20, 2022

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Colitis; Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases
• Other Study ID Numbers: VedolizumabSC-4004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No