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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05056441




Registration number
NCT05056441
Ethics application status
Date submitted
27/08/2021
Date registered
24/09/2021

Titles & IDs
Public title
A Study of Real-World Outcomes of People With Crohn's Disease (CD)
Scientific title
ENTYVIO® Real-World Outcomes in Bio-naïve Crohn's Disease Patients in Belgium, Australia, and Switzerland: An EVOLVE Observational Expansion Study
Secondary ID [1] 0 0
Vedolizumab-5066
Universal Trial Number (UTN)
Trial acronym
EVOLVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.

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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cumulative Rates of Clinical Remission Over 36 Months Compared Between VDZ and UST Cohorts
Timepoint [1] 0 0
Baseline up to 36 months post-index date
Secondary outcome [1] 0 0
Cumulative Rates of Clinical Response Over 36 Months Compared Between VDZ and UST Cohorts
Timepoint [1] 0 0
Baseline up to 36 months post-index date
Secondary outcome [2] 0 0
Cumulative Rates of Clinical Remission Over 30 Months Compared Between VDZ and UST Cohorts
Timepoint [2] 0 0
Baseline up to 30 months post-index date
Secondary outcome [3] 0 0
Cumulative Rates of Mucosal Healing Over 36 Months Compared Between VDZ and UST Cohorts
Timepoint [3] 0 0
Baseline up to 36 months post-index date
Secondary outcome [4] 0 0
Cumulative Rates of Deep Remission Over 36 Months Compared Between VDZ and UST Cohorts
Timepoint [4] 0 0
Baseline up to 36 months post-index date
Secondary outcome [5] 0 0
Cumulative Rates of Corticosteroid (CS)-free Remission Over 36 Months Compared Between VDZ and UST Cohorts
Timepoint [5] 0 0
Baseline up to 36 months post-index date
Secondary outcome [6] 0 0
Cumulative Rates of CS-free Response Over 36 Months Compared Between VDZ and UST Cohorts
Timepoint [6] 0 0
Baseline up to 36 months post-index date
Secondary outcome [7] 0 0
Time to Treatment Switching Compared Between VDZ and UST Cohorts
Timepoint [7] 0 0
From index event up to a maximum of 36 months post-index date
Secondary outcome [8] 0 0
Time to Treatment Discontinuation Compared Between VDZ and UST Cohorts
Timepoint [8] 0 0
From index event up to a maximum of 36 months post-index date
Secondary outcome [9] 0 0
Time to Dose Escalation Compared Between VDZ and UST Cohorts
Timepoint [9] 0 0
From index event up to a maximum of 36 months post-index date
Secondary outcome [10] 0 0
Incidence Rate of Adverse Events (AEs) Compared Between VDZ and UST Cohorts
Timepoint [10] 0 0
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)
Secondary outcome [11] 0 0
Incidence Rate of Serious Adverse Events (SAEs) Compared Between VDZ and UST Cohorts
Timepoint [11] 0 0
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)
Secondary outcome [12] 0 0
Incidence Rate of Serious Infections (SIs) Compared Between VDZ and UST Cohorts
Timepoint [12] 0 0
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)
Secondary outcome [13] 0 0
Incidence Rate of Emergency Department (ED) Visits Compared Between VDZ and UST Cohorts
Timepoint [13] 0 0
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)
Secondary outcome [14] 0 0
Incidence Rate of CD-related Hospitalizations Compared Between VDZ and UST Cohorts
Timepoint [14] 0 0
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)
Secondary outcome [15] 0 0
Incidence Rate of CD-related Surgical Procedures compared between VDZ and UST cohorts
Timepoint [15] 0 0
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)
Secondary outcome [16] 0 0
Incidence Rate of Disease Exacerbations Compared Between VDZ and UST Cohorts
Timepoint [16] 0 0
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)
Secondary outcome [17] 0 0
Time to Treatment Switching of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Timepoint [17] 0 0
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)
Secondary outcome [18] 0 0
Time to Treatment Discontinuation of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Timepoint [18] 0 0
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)
Secondary outcome [19] 0 0
Time to Dose Escalation of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Timepoint [19] 0 0
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)
Secondary outcome [20] 0 0
Cumulative Rates of Clinical Response of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Timepoint [20] 0 0
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)
Secondary outcome [21] 0 0
Cumulative Rates of Clinical Remission of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Timepoint [21] 0 0
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)
Secondary outcome [22] 0 0
Cumulative Rates of Mucosal Healing of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Timepoint [22] 0 0
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)
Secondary outcome [23] 0 0
Cumulative Rates of Deep Remission of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Timepoint [23] 0 0
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)
Secondary outcome [24] 0 0
Cumulative Rates of Corticosteroid (CS)-free Remission of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Timepoint [24] 0 0
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)
Secondary outcome [25] 0 0
Cumulative Rates of CS-free Response of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Timepoint [25] 0 0
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)
Secondary outcome [26] 0 0
Incidence Rate of AEs of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Timepoint [26] 0 0
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)
Secondary outcome [27] 0 0
Incidence Rate of SAEs of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Timepoint [27] 0 0
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)
Secondary outcome [28] 0 0
Incidence Rate of SIs of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Timepoint [28] 0 0
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)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2022
Sample size
Target
Accrual to date
Final
623
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
John Hunter Hospital - New Lambton
Recruitment hospital [4] 0 0
Royal Brisbane & Women's Hospital - Herston
Recruitment hospital [5] 0 0
Mater Misericordiae Health Services - South Brisbane
Recruitment hospital [6] 0 0
Integrated Gut Health Pty Ltd - Taringa
Recruitment hospital [7] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [8] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [9] 0 0
Monash Health, Monash Medical Centre - Clayton
Recruitment hospital [10] 0 0
Royal Melbourne Hospital - East Melbourne
Recruitment hospital [11] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [12] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [13] 0 0
St John of God Hospital Subiaco - Subiaco
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2305 - New Lambton
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
4068 - Taringa
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [9] 0 0
3168 - Clayton
Recruitment postcode(s) [10] 0 0
3000 - East Melbourne
Recruitment postcode(s) [11] 0 0
3004 - Melbourne
Recruitment postcode(s) [12] 0 0
6150 - Murdoch
Recruitment postcode(s) [13] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerpen
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussels
Country [3] 0 0
Belgium
State/province [3] 0 0
Hainaut
Country [4] 0 0
Belgium
State/province [4] 0 0
Oost-Vlaanderen
Country [5] 0 0
Belgium
State/province [5] 0 0
Vlaams Brabant
Country [6] 0 0
Belgium
State/province [6] 0 0
West-Vlaanderen
Country [7] 0 0
Belgium
State/province [7] 0 0
Liege
Country [8] 0 0
Switzerland
State/province [8] 0 0
Basel-Stadt (de)
Country [9] 0 0
Switzerland
State/province [9] 0 0
Bern (de)
Country [10] 0 0
Switzerland
State/province [10] 0 0
Zurich (de)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Takeda
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05056441