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

Active, not recruiting

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

• Registration Number: NCT05384080
• Lead Sponsor: Takeda

Brief 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 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 Timeline

• Study First Submitted: 2022-05-17
• Study First Submitted QC: 2022-05-17
• Study First Posted: 2022-05-20
• Study Start: 2022-08-08
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 165

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Discontinued Vedolizumab Treatment	Baseline up to 24 months
Number of Participants With Change in Vedolizumab Dosing Frequency	Baseline up to 24 months
Number of Participants With Reason for Treatment Change	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
Time to any Treatment Change	Baseline up to 24 months

Trial Locations

Locations (11)

Uniwersytecki Szpital Kliniczny; 🇵🇱 Wroclaw, Dolnoslskie, Poland

Szpital Uniwersytecki w Krakowie; 🇵🇱 Krakow, Malopolskie, Poland

Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie; 🇵🇱 Lublin, Lubelskie, Poland

Centralny Szpital Kliniczny MSWiA w Warszawie; 🇵🇱 Warszawa, Mazowieckie, Poland

Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie; 🇵🇱 Warszawa, Mazowieckie, Poland

Wojskowy Instytut Medyczny; 🇵🇱 Warszawa, Mazowieckie, Poland

HT Centrum Medyczne; 🇵🇱 Tychy, Slskie, Poland

Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Miedzychodzie; 🇵🇱 Miedzychod, Wielkopolskie, Poland

Szpital Uniwersytecki Nr 2 Im. Dr Jana Biziela W Bydgoszczy; 🇵🇱 Bydgoszcz, Kujawsko-Pomorskie, Poland

Spzoz Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego; 🇵🇱 Lodz, Lodzkie, Poland

Szpital Kliniczny Im. Heliodora Swiecickiego Uniwersytetu Medycznego Im. Karola Marcinkowskiego W Poznaniu; 🇵🇱 Poznan, Wielkopolskie, Poland