Clinical trial NCT04885920: A Study on Administration Choices of Vedolizumab and Outcomes for Adults With Inflammatory Bowel Disease (IBD) (VARIETY - CROATIA AND SLOVENIA)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Crohns Disease
Colitis, Ulcerative
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-05-13
Enrollment: 120
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.

Brief summary: Inflammatory bowel disease consists of either ulcerative colitis (UC) or Crohn's disease (CD).

The main aim of this study is to describe real-world treatment patterns in adults with moderate to severe ulcerative colitis or Crohn's disease when treated with vedolizumab. This will include the administration choices which can either be an infusion through a vein (intravenous or IV), or an injection just under the skin (subcutaneous injection, or SC).

Treatment will be determined by the study doctor according to routine clinical practice.

Detailed description: This is a non-interventional, prospective study of participants with IBD who initiated or who are currently ongoing induction or maintenance with vedolizumab in the real world setting.

The study will enroll approximately 120 participants. 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 multi-center study will be conducted in Croatia and Slovenia having specialized gastroenterology centers. The overall duration of the study will be at least 26 months. Data will be collected at baseline, at 3 months (+/- 1 month) after induction, and every 6 months (+/- 1 month) after that, and at the time of switch, discontinuation and/or at routine follow-up visits up to 12 months.

Eligibility criteria: Inclusion Criteria:

1. Has moderately to severely active IBD (UC or CD), initiating or ongoing IV induction treatment with vedolizumab in accordance with the current SmPC 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 to Treatment With Vedolizumab IV Compared to Participants With Treatment Change at 12 Months
timeFrame: Baseline up to 12 months
measure: Time to any Treatment Change
timeFrame: Baseline up to 12 months
measure: Number of Participants With Reason for Treatment Change
timeFrame: Baseline up to 12 months
measure: Number of Participants With Change in Vedolizumab Dosing Frequency
timeFrame: Baseline up to 12 months
measure: Number of Participants Who Discontinued the Vedolizumab Treatment
timeFrame: Baseline up to 12 months
measure: Number of Participants Who Changed to Another Treatment
timeFrame: Baseline up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Osijek
country: Croatia
facility: Klinicki bolnicki centar Osijek (University medical centre Osijek)
city: Rijeka
country: Croatia
facility: Klinicki bolnicki centar Rijeka (University medical centre Rijeka)
city: Split
country: Croatia
facility: Klinicki bolnicki centar Split (University medical centre Split)
city: Zagreb
country: Croatia
facility: Klinicki bolnicki centar Sestre milosrdnice (University medical centre Sestre milosrdnice)
city: Zagreb
country: Croatia
facility: Klinicki bolnicki centar Zagreb (University medical centre Zagreb)
city: Celje
country: Slovenia
facility: Splosna bolnisnica Celje (General hospital Celje)
city: Ljubljana
country: Slovenia
facility: Univerzitetni klinicni center Ljubljana (University medical Centre Ljubljana)
city: Maribor
country: Slovenia
facility: Univerzitetni klinicni center Maribor (University medical centre Maribor)
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: