Clinical trial NCT05384080: A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Poland
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)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Inflammatory Bowel Disease (IBD)
Crohn's Disease
Ulcerative Colitis
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2022-05-20
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

   .

Primary outcomes:
measure: Percentage of Participants Persisting on Treatment With Vedolizumab IV Compared to Participants With Treatment Change up to 24 Months
timeFrame: Baseline up to 24 months
measure: Time to any Treatment Change
timeFrame: Baseline up to 24 months
measure: Number of Participants Who Discontinued Vedolizumab Treatment
timeFrame: Baseline up to 24 months
measure: Number of Participants With Reason for Treatment Change
timeFrame: Baseline up to 24 months
measure: Number of Participants With Change in Vedolizumab Dosing Frequency
timeFrame: Baseline up to 24 months
measure: Number of Participants Who Changed to Another Treatment
timeFrame: Baseline up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny
state: Dolnoslskie
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki Nr 2 Im. Dr Jana Biziela W Bydgoszczy
state: Kujawsko-Pomorskie
city: Lodz
country: Poland
facility: Spzoz Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego
state: Lodzkie
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie
state: Lubelskie
city: Krakow
country: Poland
facility: Szpital Uniwersytecki w Krakowie
state: Malopolskie
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSWiA w Warszawie
state: Mazowieckie
city: Warszawa
country: Poland
facility: Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie
state: Mazowieckie
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny
state: Mazowieckie
city: Tychy
country: Poland
facility: HT Centrum Medyczne
state: Slskie
city: Miedzychod
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Miedzychodzie
state: Wielkopolskie
city: Poznan
country: Poland
facility: Szpital Kliniczny Im. Heliodora Swiecickiego Uniwersytetu Medycznego Im. Karola Marcinkowskiego W Poznaniu
state: Wielkopolskie
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: