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NCT Number: NCT05384080

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

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Key information

Conditions

Inflammatory Bowel Disease (IBD) Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Crohn's Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Ulcerative Colitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uniwersytecki Szpital Kliniczny, Wroclaw, Dolnoslskie, Poland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

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Treatment and study plan

Primary outcomes

  1. 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

  2. Time to any Treatment Change

    Time frame: Baseline up to 24 months

  3. Number of Participants Who Discontinued Vedolizumab Treatment

    Time frame: Baseline up to 24 months

  4. Number of Participants With Reason for Treatment Change

    Time frame: Baseline up to 24 months

  5. Number of Participants With Change in Vedolizumab Dosing Frequency

    Time frame: Baseline up to 24 months

  6. Number of Participants Who Changed to Another Treatment

    Time frame: Baseline up to 24 months

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study 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)

Acronym: VARIETY

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 20, 2022
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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