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

Sponsor

Takeda (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05384080

Collaborator

(none)

160

Enrollment

Locations

Anticipated Duration (Months)

14.5

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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)].

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Disease (IBD) Crohn's Disease Ulcerative Colitis

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 Design

Study Type:

Observational

Anticipated Enrollment :

160 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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)

Anticipated Study Start Date :

Aug 31, 2022

Anticipated Primary Completion Date :

Aug 31, 2025

Anticipated Study Completion Date :

Aug 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

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]
Number of Participants Who Discontinued Vedolizumab Treatment [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Uniwersytecki Szpital Kliniczny	Wroclaw	Dolnoslskie	Poland	50-556
2	Szpital Uniwersytecki Nr 2 Im. Dr Jana Biziela W Bydgoszczy	Bydgoszcz	Kujawsko-Pomorskie	Poland	85-168
3	Spzoz Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego	Lodz	Lodzkie	Poland	90-153
4	Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie	Lublin	Lubelskie	Poland	20-954
5	Szpital Uniwersytecki w Krakowie	Krakow	Malopolskie	Poland	30-688
6	Centralny Szpital Kliniczny MSWiA w Warszawie	Warszawa	Mazowieckie	Poland	02-507
7	Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie	Warszawa	Mazowieckie	Poland	02-781
8	Wojskowy Instytut Medyczny	Warszawa	Mazowieckie	Poland	04-141
9	HT Centrum Medyczne	Tychy	Slskie	Poland	43-100
10	Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Miedzychodzie	Miedzychod	Wielkopolskie	Poland	64-400
11	Szpital Kliniczny Im. Heliodora Swiecickiego Uniwersytetu Medycznego Im. Karola Marcinkowskiego W Poznaniu	Poznan	Wielkopolskie	Poland	60-335