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

NCT04885920 | Completed

• 1 other identifier: Vedolizumab-4036
• Study Type: observational
• Target: 120
• Locations: 2 countries
• Sites: 8

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.

Conditions

Inflammatory Bowel Diseases; Crohns Disease; Colitis, Ulcerative

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (8)

Klinicki bolnicki centar Osijek (University medical centre Osijek)

Osijek, 31000, Croatia

Location

Klinicki bolnicki centar Rijeka (University medical centre Rijeka)

Rijeka, 51000, Croatia

Location

Klinicki bolnicki centar Split (University medical centre Split)

Split, 21000, Croatia

Location

Klinicki bolnicki centar Sestre milosrdnice (University medical centre Sestre milosrdnice)

Zagreb, 10000, Croatia

Location

Klinicki bolnicki centar Zagreb (University medical centre Zagreb)

Zagreb, 10000, Croatia

Location

Splosna bolnisnica Celje (General hospital Celje)

Celje, 3000, Slovenia

Location

Univerzitetni klinicni center Ljubljana (University medical Centre Ljubljana)

Ljubljana, 1000, Slovenia

Location

Univerzitetni klinicni center Maribor (University medical centre Maribor)

Maribor, 2000, Slovenia

Location

Related Links

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

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 13, 2021
• Study Start: February 22, 2022
• Primary Completion: March 12, 2024
• Study Completion: March 12, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.

Locations

SL (3); CR (5)