A Study on Administration Choices of Vedolizumab and Outcomes for Adults With Inflammatory Bowel Disease (IBD)

Purpose of this study?

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.

Inclusion Criteria:

Has moderately to severely active IBD (UC or CD), initiating or ongoing IV induction treatment with vedolizumab in accordance with the current SmPC¹ 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 SmPC¹.
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 outcome measures:

1. Percentage of Participants Persisting to Treatment With Vedolizumab IV Compared to  Participants With Treatment Change at 12 Months [Time Frame: Baseline up to 12 months]
2. Time to any Treatment Change [Time Frame: Baseline up to 12 months]
3. Number of Participants With Reason for Treatment Change [Time Frame: Baseline up to 12 months]
4. Number of Participants With Change in Vedolizumab Dosing Frequency [Time Frame: Baseline up to 12 months]
5. Number of Participants Who Discontinued the Vedolizumab Treatment [Time Frame: Baseline up to 12 months]
6. Number of Participants Who Changed to Another Treatment [Time Frame: Baseline up to 12 months]

Study Locations in Europe:

Croatia, Slovenia

Estimated Study Completion Date: December 1, 2023

Further information on clinicaltrial.gov with trial number NCT04885920