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

Inflammatory Bowel Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04885920
• Other study ID #: Vedolizumab-4036
• Status: Completed
• Start date: February 22, 2022
• Est. completion date: March 12, 2024

Study information

• Verified date: April 2024
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 12, 2024
• Est. primary completion date: March 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Crohns Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Locations

Country	Name	City	State
Croatia	Klinicki bolnicki centar Osijek (University medical centre Osijek)	Osijek
Croatia	Klinicki bolnicki centar Rijeka (University medical centre Rijeka)	Rijeka
Croatia	Klinicki bolnicki centar Split (University medical centre Split)	Split
Croatia	Klinicki bolnicki centar Sestre milosrdnice (University medical centre Sestre milosrdnice)	Zagreb
Croatia	Klinicki bolnicki centar Zagreb (University medical centre Zagreb)	Zagreb
Slovenia	Splosna bolnisnica Celje (General hospital Celje)	Celje
Slovenia	Univerzitetni klinicni center Ljubljana (University medical Centre Ljubljana)	Ljubljana
Slovenia	Univerzitetni klinicni center Maribor (University medical centre Maribor)	Maribor

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Countries where clinical trial is conducted

Croatia,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Persisting to Treatment With Vedolizumab IV Compared to Participants With Treatment Change at 12 Months		Baseline up to 12 months
Primary	Time to any Treatment Change		Baseline up to 12 months
Primary	Number of Participants With Reason for Treatment Change		Baseline up to 12 months
Primary	Number of Participants With Change in Vedolizumab Dosing Frequency		Baseline up to 12 months
Primary	Number of Participants Who Discontinued the Vedolizumab Treatment		Baseline up to 12 months
Primary	Number of Participants Who Changed to Another Treatment		Baseline up to 12 months

External Links

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