A Study of Vedolizumab in Adults With Crohn's Disease (CD) (SUNRISE)

Takeda

Status: Completed

Conditions: Crohn's Disease

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT05192863

Vedolizumab-4038

Details and patient eligibility

About

The main aim of this study is to see if adults with CD treated with vedolizumab have less symptoms and inflammation of the bowel assessed by ultrasonography.

Participants will be treated with vedolizumab according to their clinic's standard practice.

Full description

This is a non-interventional, prospective study of participants with moderately to severely active CD who are initiating treatment with vedolizumab according to the current summary of product characteristics (SmPC) 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 CD

This multi-center study will be conducted in Canada, Italy, and Israel at specialized gastroenterology centers. The overall duration of the study will be 18 months.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Has moderately to severely active CD with a BWT of >3 mm, based on IUS performed within the previous 4 weeks from baseline.
2. Newly initiating IV vedolizumab induction treatment in accordance with the current SmPC either at enrolment or within 2 weeks after enrolment (switch to SC is acceptable at maintenance treatment stage).

Exclusion criteria

1. Prior history of intolerability, hypersensitivity to the active substance or to any of the excipients of vedolizumab.
2. Active severe infections such as tuberculosis (TB), sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as Progressive Multifocal Leukoencephalopathy (PML).
3. Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
4. Current or previous participation in an interventional clinical trial for CD within the past 30 days, or planned to be enrolled in an interventional clinical trial for CD.
5. Ongoing or planned pregnancy or breastfeeding participants.
6. Active perforating complications or significant current strictures (assessed by IUS, with or without pre-stenotic dilatation) as per clinical judgement.
7. Characteristics precluding IUS visualization of affected bowel segments or normal BWT of <=3 mm for all segments.

Trial design

72 participants in 1 patient group

Participants with CD

Description:

Participants diagnosed with moderately to severely active CD who are initiating vedolizumab intravenous (IV) induction treatment with the option to switch to vedolizumab subcutaneous (SC) treatment, as maintenance therapy in accordance with the current SmPC will be observed prospectively for 18 months.

Treatment:

Other: No Intervention