Prospective, Non-interventional, Observational Study in Patients With IBD Receiving IV or SC Vedolizumab Therapy to Observe Route of Administration Choices and Outcomes (VARIETY-Switzerland)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 92
- Locations
- 6
- Primary Endpoint
- Number of Participants Who Discontinued Vedolizumab Treatment
Study Overview
Brief Summary
Vedolizumab is a medicine that helps to reduce sensitivity and pain in the digestive system for participants with UC or CD.
In this study, adults with UC or CD will be treated with vedolizumab according to their clinic's standard practice. Participants will receive vedolizumab as either an infusion or an injection just under the skin (subcutaneous). The main aim of the study is to observe real-world treatment patterns in participants treated with vedolizumab.
The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.
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 100 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 Switzerland at specialized gastroenterology centers. The overall duration of the study will be 24 months (104 weeks). Data will be collected at baseline, at 3 months (12 weeks) after induction, and every 6 months (24 weeks) after that, and at the time of switch, discontinuation and/or at routine follow-up visits up to 12 months (48 weeks).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Outcomes
Primary Outcomes
Number of Participants Who Discontinued Vedolizumab Treatment
Time Frame: Baseline up to 12 months
Number of Participants Who Changed to Another Treatment
Time Frame: Baseline up to 12 months
Time to any Treatment Change
Time Frame: Baseline up to 12 months
Percentage of Participants Persisting on Treatment With Vedolizumab IV Compared to Participants With Treatment Change up to 12 Months
Time Frame: Baseline up to 12 months
Number of Participants With Reason for Treatment Change
Time Frame: Baseline up to 12 months
Number of Participants With Change in Vedolizumab Dosing Frequency
Time Frame: Baseline up to 12 months
Secondary Outcomes
No secondary outcomes reported