A Study on Administration Choices of Vedolizumab and Outcomes for Adults With Inflammatory Bowel Disease (IBD) (VARIETY - CROATIA AND SLOVENIA)

Prospective, Non-interventional, Observational Study in Patients With IBD Receiving IV or SC Vedolizumab Therapy to Observe Route of Administration Choices and Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohns Disease

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.

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Croatia
  • Osijek, Croatia, 31000
    • Klinicki bolnicki centar Osijek (University medical centre Osijek)
  • Rijeka, Croatia, 51000
    • Klinicki bolnicki centar Rijeka (University medical centre Rijeka)
  • Split, Croatia, 21000
    • Klinicki bolnicki centar Split (University medical centre Split)
  • Zagreb, Croatia, 10000
    • Klinicki bolnicki centar Sestre milosrdnice (University medical centre Sestre milosrdnice)
  • Zagreb, Croatia, 10000
    • Klinicki bolnicki centar Zagreb (University medical centre Zagreb)
• Slovenia
  • Celje, Slovenia, 3000
    • Splosna bolnisnica Celje (General hospital Celje)
  • Ljubljana, Slovenia, 1000
    • Univerzitetni klinicni center Ljubljana (University medical Centre Ljubljana)
  • Maribor, Slovenia, 2000
    • Univerzitetni klinicni center Maribor (University medical centre Maribor)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Participants With IBD; Participants diagnosed with moderately to severely active IBD (UC or CD) who initiated or are currently ongoing vedolizumab IV induction treatment in accordance with the current Summary of Product Characteristics (SmPC) or receiving vedolizumab ongoing or maintenance IV treatment with the option to switch to vedolizumab SC treatment, will be observed prospectively for at least 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants Persisting to Treatment With Vedolizumab IV Compared to Participants With Treatment Change at 12 Months	Baseline up to 12 months
Time to any Treatment Change	Baseline up to 12 months
Number of Participants With Reason for Treatment Change	Baseline up to 12 months
Number of Participants With Change in Vedolizumab Dosing Frequency	Baseline up to 12 months
Number of Participants Who Discontinued the Vedolizumab Treatment	Baseline up to 12 months
Number of Participants Who Changed to Another Treatment	Baseline up to 12 months

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2022
• Primary Completion (Actual): March 12, 2024
• Study Completion (Actual): March 12, 2024

Study Registration Dates

• First Submitted: May 12, 2021
• First Submitted That Met QC Criteria: May 12, 2021
• First Posted (Actual): May 13, 2021

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Colitis; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases; Colitis, Ulcerative
• Other Study ID Numbers: Vedolizumab-4036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No