A Study of Real-World Outcomes of People With Crohn's Disease (CD) (EVOLVE)

Takeda

Status: Completed

Conditions: Crohn Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT05056441

Vedolizumab-5066

Details and patient eligibility

About

The main aim of this study is to compare long-term remission in participants receiving vedolizumab (VDZ) and those receiving ustekinumab (UST).

In this study, the study doctors will review each participant's past medical records. This study is about collecting existing information only; participants will not receive treatment or need to visit a study doctor during this study.

Full description

This is a non-interventional, retrospective study of participants with CD. The study will review the medical charts of participants who have initiated the treatment with vedolizumab and ustekinumab or another biologic agent (post- index).

The study will aim to enroll approximately 700 participants, with 350 participants in each of the following cohorts:

• Cohort 1: Vedolizumab
• Cohort 2: Ustekinumab

The data for participants will be collected in two main periods:

• Pre-Index Event Period: From the date of diagnosis of CD until the date of index when vedolizumab or ustekinumab was initiated during the eligibility period.
• Post-Index Event Period: From one day post-index when vedolizumab or ustekinumab was initiated during the eligibility period until chart abstraction initiation, unless the date of death or loss to follow-up is before the date of chart abstraction initiation.

This multi-center study will be conducted in Belgium, Australia, and Switzerland. The overall time for data collection in the study will be approximately 12 months and the long-term duration of the study is approximately 36 months.

Enrollment: 623 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Has a diagnosis of CD documented in the medical records.
2. Has received at least one dose of vedolizumab or ustekinumab at one of the participating study sites during the eligibility period.
3. Was biologic-naïve (no prior biologic use for any pathology, including CD) at the time of index event.
4. Has completed induction phase and has a minimum of a six-month duration between the date of the index event and the date of chart abstraction initiation and was still under active care at the site six months post-index date.

Exclusion criteria

1. Has received vedolizumab or ustekinumab as part of a clinical trial in their lifetime (includes index event).
2. Has initiated index treatment as combination therapy with two biologic agents.
3. Has received previous treatment with biologic agents for CD or conditions other than CD ever in their lifetime.
4. Has medical chart empty or missing.
5. Part or all of the participant's index treatment was received at a different site, and the participant's medical chart pertaining to this care is not accessible.
6. Has received a subcutaneous formulation of ustekinumab for induction (that is, a subcutaneous induction dose of ustekinumab prior to ustekinumab's approval for CD in the study countries).

Trial design

623 participants in 2 patient groups

Cohort 1: Vedolizumab

Description:

Biologic-naïve participants diagnosed with CD, who have initiated vedolizumab treatment will be observed from the data of diagnosis of CD until the date of index when vedolizumab treatment was initiated during the eligibility period until the earliest of chart abstraction initiation, death or last contact with the site. Index date is defined as the date when vedolizumab treatment was initiated.

Cohort 2: Ustekinumab

Description:

Biologic-naïve participants diagnosed with CD, who have initiated ustekinumab treatment will be observed from the data of diagnosis of CD until the date of index when ustekinumab treatment was initiated during the eligibility period until the earliest of chart abstraction initiation, death or last contact with the site. Index date is defined as the date when ustekinumab treatment was initiated.