Clinical trial NCT05056441: A Study of Real-World Outcomes of People With Crohn's Disease (CD)
Official title: ENTYVIO® Real-World Outcomes in Bio-naïve Crohn's Disease Patients in Belgium, Australia, and Switzerland: An EVOLVE Observational Expansion Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-09-24
Enrollment: 623
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Biologic-naïve CD participants who initiated biologic treatment with vedolizumab or ustekinumab (index event) during the eligibility period.

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.

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).

Primary outcomes:
measure: Cumulative Rates of Clinical Remission Over 36 Months Compared Between VDZ and UST Cohorts
timeFrame: Baseline up to 36 months post-index date
Secondary outcomes:
measure: Cumulative Rates of Clinical Response Over 36 Months Compared Between VDZ and UST Cohorts
timeFrame: Baseline up to 36 months post-index date
measure: Cumulative Rates of Clinical Remission Over 30 Months Compared Between VDZ and UST Cohorts
timeFrame: Baseline up to 30 months post-index date
measure: Cumulative Rates of Mucosal Healing Over 36 Months Compared Between VDZ and UST Cohorts
timeFrame: Baseline up to 36 months post-index date
measure: Cumulative Rates of Deep Remission Over 36 Months Compared Between VDZ and UST Cohorts
timeFrame: Baseline up to 36 months post-index date
measure: Cumulative Rates of Corticosteroid (CS)-free Remission Over 36 Months Compared Between VDZ and UST Cohorts
timeFrame: Baseline up to 36 months post-index date
measure: Cumulative Rates of CS-free Response Over 36 Months Compared Between VDZ and UST Cohorts
timeFrame: Baseline up to 36 months post-index date
measure: Time to Treatment Switching Compared Between VDZ and UST Cohorts
timeFrame: From index event up to a maximum of 36 months post-index date
measure: Time to Treatment Discontinuation Compared Between VDZ and UST Cohorts
timeFrame: From index event up to a maximum of 36 months post-index date
measure: Time to Dose Escalation Compared Between VDZ and UST Cohorts
timeFrame: From index event up to a maximum of 36 months post-index date
measure: Incidence Rate of Adverse Events (AEs) Compared Between VDZ and UST Cohorts
timeFrame: From the index event (Baseline) to the earliest date of chart abstraction initiation, death or last contact with the site (up to approximately Month 6 post-index date)
measure: Incidence Rate of Serious Adverse Events (SAEs) Compared Between VDZ and UST Cohorts
timeFrame: From the index event (Baseline) to the earliest date of chart abstraction initiation, death or last contact with the site (up to approximately Month 6 post-index date)
measure: Incidence Rate of Serious Infections (SIs) Compared Between VDZ and UST Cohorts
timeFrame: From the index event (Baseline) to the earliest date of chart abstraction initiation, death or last contact with the site (up to approximately Month 6 post-index date)
measure: Incidence Rate of Emergency Department (ED) Visits Compared Between VDZ and UST Cohorts
timeFrame: From the index event (Baseline) to the earliest date of chart abstraction initiation, death or last contact with the site (up to approximately Month 12 post-index date)
measure: Incidence Rate of CD-related Hospitalizations Compared Between VDZ and UST Cohorts
timeFrame: From the index event (Baseline) to the earliest date of chart abstraction initiation, death or last contact with the site (up to approximately Month 12 post-index date)
measure: Incidence Rate of CD-related Surgical Procedures compared between VDZ and UST cohorts
timeFrame: From the index event (Baseline) to the earliest date of chart abstraction initiation, death or last contact with the site (up to approximately Month 12 post-index date)
measure: Incidence Rate of Disease Exacerbations Compared Between VDZ and UST Cohorts
timeFrame: From the date of initiation of subsequent line treatment up to the earliest date of chart abstraction initiation, death or last contact with the site (up to a maximum of 36 months post-index date)
measure: Time to Treatment Switching of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
timeFrame: From the date of initiation of subsequent line treatment up to the earliest date of chart abstraction initiation, death or last contact with the site (up to a maximum of 36 months post-index date)
measure: Time to Treatment Discontinuation of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
timeFrame: From the date of initiation of subsequent line treatment up to the earliest date of chart abstraction initiation, death or last contact with the site (up to a maximum of 36 months post-index date)
measure: Time to Dose Escalation of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
timeFrame: From the date of initiation of subsequent line treatment up to the earliest date of chart abstraction initiation, death or last contact with the site (up to a maximum of 36 months post-index date)
measure: Cumulative Rates of Clinical Response of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
timeFrame: From the date of initiation of subsequent line treatment up to the earliest date of chart abstraction initiation, death or last contact with the site (up to a maximum of 36 months post-index date)
measure: Cumulative Rates of Clinical Remission of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
timeFrame: From the date of initiation of subsequent line treatment up to the earliest date of chart abstraction initiation, death or last contact with the site (up to a maximum of 36 months post-index date)
measure: Cumulative Rates of Mucosal Healing of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
timeFrame: From the date of initiation of subsequent line treatment up to the earliest date of chart abstraction initiation, death or last contact with the site (up to a maximum of 36 months post-index date)
measure: Cumulative Rates of Deep Remission of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
timeFrame: From the date of initiation of subsequent line treatment up to the earliest date of chart abstraction initiation, death or last contact with the site (up to a maximum of 36 months post-index date)
measure: Cumulative Rates of Corticosteroid (CS)-free Remission of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
timeFrame: From the date of initiation of subsequent line treatment up to the earliest date of chart abstraction initiation, death or last contact with the site (up to a maximum of 36 months post-index date)
measure: Cumulative Rates of CS-free Response of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
timeFrame: From the date of initiation of subsequent line treatment up to the earliest date of chart abstraction initiation, death or last contact with the site (up to a maximum of 36 months post-index date)
measure: Incidence Rate of AEs of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
timeFrame: From the date of initiation of subsequent line treatment up to the earliest date of chart abstraction initiation, death or last contact with the site (up to a maximum of 36 months post-index date)
measure: Incidence Rate of SAEs of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
timeFrame: From the date of initiation of subsequent line treatment up to the earliest date of chart abstraction initiation, death or last contact with the site (up to a maximum of 36 months post-index date)
measure: Incidence Rate of SIs of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
timeFrame: From the date of initiation of subsequent line treatment up to the earliest date of chart abstraction initiation, death or last contact with the site (up to a maximum of 36 months post-index date)
Other outcomes:
Locations:
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: New Lambton
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane & Women's Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Misericordiae Health Services
state: Queensland
city: Taringa
country: Australia
facility: Integrated Gut Health Pty Ltd
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Elizabeth Vale
country: Australia
facility: Lyell McEwin Hospital
state: South Australia
city: Clayton
country: Australia
facility: Monash Health, Monash Medical Centre
state: Victoria
city: East Melbourne
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Subiaco
country: Australia
facility: St John of God Hospital Subiaco
state: Western Australia
city: Bonheiden
country: Belgium
facility: Imelda VZW
state: Antwerpen
city: Edegem
country: Belgium
facility: UZ Antwerpen
state: Antwerpen
city: Anderlecht
country: Belgium
facility: Hopital Erasme
state: Brussels
city: Mons
country: Belgium
facility: Centre Hospitalier Universitaire Ambroise Pare
state: Hainaut
city: Tournai
country: Belgium
facility: CHWAPI Tournai
state: Hainaut
city: Gent
country: Belgium
facility: AZ Sint-Lucas
state: Oost-Vlaanderen
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams Brabant
city: Kortrijk
country: Belgium
facility: AZ Groeninge
state: West-Vlaanderen
city: Roeselare
country: Belgium
facility: AZ Delta
state: West-Vlaanderen
city: Brussels
country: Belgium
facility: CHU St-Pierre
city: Liege
country: Belgium
facility: Centre Hospitalier Chretien MontLegia
city: Liege
country: Belgium
facility: CHU de Liege
city: Basel
country: Switzerland
facility: Clarunis Bauchzenturm
state: Basel-Stadt (de)
city: Bern
country: Switzerland
facility: Inselspital Bern
state: Bern (de)
city: Bern
country: Switzerland
facility: Intesto KLG Gastroenterologische Praxis Crohn-Colitis-Zentrum
state: Bern (de)
city: Zurich
country: Switzerland
facility: Stadtspital Triemli Zurich
state: Zurich (de)
city: Zurich
country: Switzerland
facility: Universitatsspital Zurich
state: Zurich (de)
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: