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

NCT ID: NCT05056441

Last Updated: 2022-10-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 623 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-09-30

Brief Summary

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.

Detailed 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.

Conditions

Crohn Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Cohort 1: Vedolizumab

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.

No interventions assigned to this group

Cohort 2: Ustekinumab

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.

No interventions assigned to this group

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

John Hunter Hospital

New Lambton, New South Wales, Australia

Royal Brisbane & Women's Hospital

Herston, Queensland, Australia

Mater Misericordiae Health Services

South Brisbane, Queensland, Australia

Integrated Gut Health Pty Ltd

Taringa, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Lyell McEwin Hospital

Elizabeth Vale, South Australia, Australia

Monash Health, Monash Medical Centre

Clayton, Victoria, Australia

Royal Melbourne Hospital

East Melbourne, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

St John of God Hospital Subiaco

Subiaco, Western Australia, Australia

Imelda VZW

Bonheiden, Antwerpen, Belgium

UZ Antwerpen

Edegem, Antwerpen, Belgium

Hopital Erasme

Anderlecht, Brussels Capital, Belgium

Centre Hospitalier Universitaire Ambroise Pare

Mons, Hainaut, Belgium

CHWAPI Tournai

Tournai, Hainaut, Belgium

AZ Sint-Lucas

Ghent, Oost-Vlaanderen, Belgium

UZ Gent

Ghent, Oost-Vlaanderen, Belgium

UZ Leuven

Leuven, Vlaams Brabant, Belgium

AZ Groeninge

Kortrijk, West-Vlaanderen, Belgium

AZ Delta

Roeselare, West-Vlaanderen, Belgium

CHU St-Pierre

Brussels, , Belgium

Centre Hospitalier Chretien MontLegia

Liège, , Belgium

CHU de Liege

Liège, , Belgium

Clarunis Bauchzenturm

Basel, Basel-Stadt (de), Switzerland

Inselspital Bern

Bern, Bern (de), Switzerland

Intesto KLG Gastroenterologische Praxis Crohn-Colitis-Zentrum

Bern, Bern (de), Switzerland

Stadtspital Triemli Zurich

Zurich, Zurich (de), Switzerland

Universitatsspital Zurich

Zurich, Zurich (de), Switzerland

Countries

Australia; Belgium; Switzerland

References

Christensen B, Scharl M, Bressler B, Khan Z, Halchenko Y, Gisler C, Kamble P, Adsul S, Farhat Z, Ferrante M. Real-World Clinical Effectiveness and Safety of Vedolizumab and Ustekinumab in Biologic-Naive Patients With Early or Late Crohn's Disease: Results From the EVOLVE Expansion Study. Crohns Colitis 360. 2025 Jul 9;7(3):otaf031. doi: 10.1093/crocol/otaf031. eCollection 2025 Jul.

Reference Type: DERIVED

PMID: 40641824 (View on PubMed)

Related Links

https://clinicaltrials.takeda.com/study-detail/614e34bbc15195002c0ba31b

To obtain more information on the study, click here/on this link

Other Identifiers

Vedolizumab-5066

Identifier Type: -

Identifier Source: org_study_id