ENTYVIO in Bio-naive Patients With Moderate/Severe Crohn's Disease (CD) in Daily Practice (EARLY-CD)

Takeda

Status: Withdrawn

Conditions: Crohn Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT04349449

Vedolizumab-4022

MACS-2017-102118 (Other Identifier)

U1111-1217-6862 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to describe physician-reported clinical effectiveness outcomes, as determined by Harvey-Bradshaw Index (HBI) assessment, in biologic-naive participants with CD over 12 months following treatment initiation with vedolizumab.

Full description

This is a non-interventional, single-cohort, prospective study of participants with moderate to severe CD. The study will review medical charts with prospective patient-reported outcome measures to provide real-world data to describe clinical outcomes and participant-reported symptom experience over 12 months following vedolizumab treatment initiation.

The study will enroll approximately 140 participants. All participants will be enrolled in one observational group:

• Vedolizumab

This multicenter trial will be conducted in Canada. The overall duration of study will be approximately 24 months, including participant's enrolment period of 12 months and follow-up data collection period of 12 months.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Is enrolled in Takeda's participant support program prior to receiving vedolizumab.
2. Has a diagnosis of moderately-to-severely active CD, as documented in the medical records.
3. Scheduled for initial vedolizumab treatment per usual care recommendation.
4. Was biologic-naive at time of initiating vedolizumab treatment.

Exclusion criteria

1. Was prescribed vedolizumab as part of a clinical study.
2. Has isolated and active perianal disease in the absence of luminal CD.

Trial design

0 participants in 1 patient group

Vedolizumab Participants

Description:

Participants diagnosed with moderate to severe CD from approximately 20 investigational sites will be observed over a period of 12 months after initiation of treatment with vedolizumab, intravenous infusion under standard clinical care.