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

Ulcerative Colitis Clinical Trial

— VARIETY  

Official 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05384080
• Other study ID #: VedolizumabSC-4004
• Status: Active, not recruiting
• Start date: August 8, 2022
• Est. completion date: August 31, 2025

Study information

• Verified date: September 2023
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)].

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 165
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Disease (IBD)
• Inflammatory Bowel Diseases
• Ulcer
• Ulcerative Colitis

Locations

Country	Name	City	State
Poland	Szpital Uniwersytecki Nr 2 Im. Dr Jana Biziela W Bydgoszczy	Bydgoszcz	Kujawsko-Pomorskie
Poland	Szpital Uniwersytecki w Krakowie	Krakow	Malopolskie
Poland	Spzoz Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego	Lodz	Lodzkie
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie	Lublin	Lubelskie
Poland	Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Miedzychodzie	Miedzychod	Wielkopolskie
Poland	Szpital Kliniczny Im. Heliodora Swiecickiego Uniwersytetu Medycznego Im. Karola Marcinkowskiego W Poznaniu	Poznan	Wielkopolskie
Poland	HT Centrum Medyczne	Tychy	Slskie
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	Uniwersytecki Szpital Kliniczny	Wroclaw	Dolnoslskie

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Persisting on Treatment With Vedolizumab IV Compared to Participants With Treatment Change up to 24 Months		Baseline up to 24 months
Primary	Time to any Treatment Change		Baseline up to 24 months
Primary	Number of Participants Who Discontinued Vedolizumab Treatment		Baseline up to 24 months
Primary	Number of Participants With Reason for Treatment Change		Baseline up to 24 months
Primary	Number of Participants With Change in Vedolizumab Dosing Frequency		Baseline up to 24 months
Primary	Number of Participants Who Changed to Another Treatment		Baseline up to 24 months

External Links

•   To obtain more information on the study, click on this link.