Crohn DiseaseEVOLVENCT05056441
A Study of Real-World Outcomes of People With Crohn's Disease (CD)
An observational study of Crohn Disease, run by Takeda at 31 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- How many people
- 623 participants
- Where
- 31 sitesin 3 countries
- Study dates
- 1 Dec 2021to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Biologic-naïve CD participants who initiated biologic treatment with vedolizumab or ustekinumab (index event) during the eligibility period.
Who may be able to join
- Has a diagnosis of CD documented in the medical records.
- Has received at least one dose of vedolizumab or ustekinumab at one of the participating study sites during the eligibility period.
- Was biologic-naïve (no prior biologic use for any pathology, including CD) at the time of index event.
- 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.
Who cannot join
- Has received vedolizumab or ustekinumab as part of a clinical trial in their lifetime (includes index event).
- Has initiated index treatment as combination therapy with two biologic agents.
- Has received previous treatment with biologic agents for CD or conditions other than CD ever in their lifetime.
- Has medical chart empty or missing.
- 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.
- 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 locations and contacts
31 sites in 3 countries.
31 sites in 3 countries
Australia13 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Monash Health, Monash Medical Centre
Clayton, Victoria, 3168
Concord Repatriation General Hospital
Concord, New South Wales, 2139
Royal Melbourne Hospital
East Melbourne, Victoria, 3000
Lyell McEwin Hospital
Elizabeth Vale, South Australia, 5112
Royal Brisbane & Women's Hospital
Herston, Queensland, 4029
Liverpool Hospital
Liverpool, New South Wales, 2170
The Alfred Hospital
Melbourne, Victoria, 3004
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
John Hunter Hospital
New Lambton, New South Wales, 2305
Mater Misericordiae Health Services
South Brisbane, Queensland, 4101
St John of God Hospital Subiaco
Subiaco, Western Australia, 6008
Integrated Gut Health Pty Ltd
Taringa, Queensland, 4068
Belgium13 sites
Hopital Erasme
Anderlecht, Brussels Capital, 1070
Imelda VZW
Bonheiden, Antwerpen, 2820
CHU St-Pierre
Brussels, 1000
UZ Antwerpen
Edegem, Antwerpen, 2650
AZ Sint-Lucas
Ghent, Oost-Vlaanderen, 9000
UZ Gent
Ghent, Oost-Vlaanderen, 9000
AZ Groeninge
Kortrijk, West-Vlaanderen, 8500
UZ Leuven
Leuven, Vlaams Brabant, 3000
Centre Hospitalier Chretien MontLegia
Liège, 4000
CHU de Liege
Liège, 4000
Centre Hospitalier Universitaire Ambroise Pare
Mons, Hainaut, 7000
AZ Delta
Roeselare, West-Vlaanderen, 8800
CHWAPI Tournai
Tournai, Hainaut, 7500
Switzerland5 sites
Clarunis Bauchzenturm
Basel, Basel-Stadt (de), 4051
Inselspital Bern
Bern, Bern (de), 3010
Intesto KLG Gastroenterologische Praxis Crohn-Colitis-Zentrum
Bern, Bern (de), 3012
Stadtspital Triemli Zurich
Zurich, Zurich (de), 8063
Universitatsspital Zurich
Zurich, Zurich (de), 8091
About this study
Official title: ENTYVIO® Real-World Outcomes in Bio-naïve Crohn's Disease Patients in Belgium, Australia, and Switzerland: An EVOLVE Observational Expansion Study
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.
Read the 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
- Keywords
- Drug Therapy
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Rates of Clinical Remission Over 36 Months Compared Between VDZ and UST Cohorts
Clinical remission will be defined as Crohn's Disease Activity Index (CDAI) score less than (<) 150 points, or if unknown, Harvey-Bradshaw Index (HBI) Overall score less than or equal to (<=) 4 points, or if unknown, Modified HBI (mHBI) score <=4 points, or if unknown, changes in biomarker assessments (C-reactive Protein, Fecal Calprotectin, and albumin) or remission status recorded in medical chart as 'in remission'. CDAI score <150 indicates quiescent disease and >450 indicates extremely severe disease. HBI consisted of 5 clinical parameters: general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications. mHBI consisted of 4 clinical parameters- general well-being, abdominal pain, number of liquid stools per day and additional manifestation. HBI and mHBI total score will be sum of individual parameters, score ranges 0 to no pre-specified maximum score as it depends on number of liquid stools, where higher scores is more severe disease.
Measured: Baseline up to 36 months post-index date
Secondary outcomes (28)
Cumulative Rates of Clinical Response Over 36 Months Compared Between VDZ and UST Cohorts
Clinical response will be defined as CDAI positive change in score from baseline, or if unknown, HBI overall score decrease of >=3 points from baseline, or if unknown, Modified HBI score decrease of >=3 points from baseline, or if unknown, changes in biomarker assessments (CRP, FCP, and albumin) or treatment response recorded in the medical chart as 'complete response' or 'partial response'. CDAI score <150 indicates quiescent disease and >450 indicates extremely severe disease. HBI consisted of 5 clinical parameters: general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications. mHBI consisted of 4 clinical parameters- general well-being, abdominal pain, number of liquid stools per day and additional manifestation. HBI and mHBI total score will be sum of individual parameters, score ranges 0 to no pre-specified maximum score as it depends on number of liquid stools, where higher scores is more severe disease.
Measured: Baseline up to 36 months post-index date
Cumulative Rates of Clinical Remission Over 30 Months Compared Between VDZ and UST Cohorts
Clinical remission will be defined as CDAI score <150 points, or if unknown, HBI Overall score of <=4 points, or if unknown, mHBI score of <=4 points, or if unknown, changes in biomarker assessments (CRP, FCP, and albumin) or remission status recorded in the medical chart as 'in remission'. CDAI score <150 indicates quiescent disease and >450 indicates extremely severe disease. HBI consisted of 5 clinical parameters: general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications. mHBI consisted of 4 clinical parameters- general well-being, abdominal pain, number of liquid stools per day and additional manifestation. HBI and mHBI total score will be sum of individual parameters, score ranges 0 to no pre-specified maximum score as it depends on number of liquid stools, where higher scores is more severe disease.
Measured: Baseline up to 30 months post-index date
Cumulative Rates of Mucosal Healing Over 36 Months Compared Between VDZ and UST Cohorts
Mucosal healing will be defined as endoscopic assessment score = 0 or 1 (that is, normal or inactive disease or mild disease), or if unknown, Simple Endoscopic Score for Crohn's Disease [SES-CD] score of <3, 'lack of ulceration' defined by one or more of the following endoscopic procedure findings either selection of 'no ulcers' or free-text indication of 'lack of ulceration', or if unknown, one or more endoscopic procedure findings indicating inactive disease (no findings/no active disease, no erosion, no ulcers, no inflammation or inflammatory activity, or no pathological findings), with higher scores indicating more severe disease. The score for each endoscopic variable is sum of values obtained for each segment. The SES-CD total is sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
Measured: Baseline up to 36 months post-index date
Cumulative Rates of Deep Remission Over 36 Months Compared Between VDZ and UST Cohorts
Deep remission (clinical remission and mucosal healing) is defined as CDAI score <150 and SES-CD score <3. CDAI is scoring system for the assessment of CD activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease. The SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of the surface area affected, and stenosis in 5 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
Measured: Baseline up to 36 months post-index date
Cumulative Rates of Corticosteroid (CS)-free Remission Over 36 Months Compared Between VDZ and UST Cohorts
CS-free remission is defined as participants using oral corticosteroids at baseline who have discontinued corticosteroids and have clinical remission up to 36-months.
Measured: Baseline up to 36 months post-index date
Cumulative Rates of CS-free Response Over 36 Months Compared Between VDZ and UST Cohorts
Corticosteroid-free response is defined as participants using oral corticosteroids at baseline who have discontinued oral corticosteroids and have clinical response up to 36-months.
Measured: Baseline up to 36 months post-index date
Time to Treatment Switching Compared Between VDZ and UST Cohorts
Time to Treatment Switching is defined as time from index treatment initiation until a participant initiates subsequent treatments.
Measured: From index event up to a maximum of 36 months post-index date
Time to Treatment Discontinuation Compared Between VDZ and UST Cohorts
Time to Treatment Discontinuation is defined as time from index treatment initiation until participant discontinues index treatment without switching to subsequent treatments.
Measured: From index event up to a maximum of 36 months post-index date
Time to Dose Escalation Compared Between VDZ and UST Cohorts
Time to Dose Escalation is defined as time from index treatment initiation until increase in index treatment frequency or dose and/or treatment frequency for >=2 consecutive drug administrations.
Measured: From index event up to a maximum of 36 months post-index date
Incidence Rate of Adverse Events (AEs) Compared Between VDZ and UST Cohorts
Incidence rate of AE will be measured in per 100 person-years. 100 person-years will be used as it is a method that can account for large among-participant variations in follow-up time.
Measured: 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)
Incidence Rate of Serious Adverse Events (SAEs) Compared Between VDZ and UST Cohorts
Incidence rate of SAEs will be measured in per 100 person-years. 100 person-years will be used as it is a method that can account for large among-participant variations in follow-up time. SAE is defined as an AE that either results in death, was a life threatening event), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event in the opinion of the physician.
Measured: 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)
Incidence Rate of Serious Infections (SIs) Compared Between VDZ and UST Cohorts
Incidence rate of SIs will be measured in per 100 person-years. 100 person-years will be used as it is a method that can account for large among-participant variations in follow-up time. SI is defined as an SAE that is an infection.
Measured: 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)
Incidence Rate of Emergency Department (ED) Visits Compared Between VDZ and UST Cohorts
Incidence rate of ED will be measured in per 100 person-years. 100 person-years will be used as it is a method that can account for large among-participant variations in follow-up time.
Measured: 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)
Incidence Rate of CD-related Hospitalizations Compared Between VDZ and UST Cohorts
Incidence rate of CD-related hospitalizations will be measured in per 100 person-years. 100 person-years will be used as it is a method that can account for large among-participant variations in follow-up time. and CD-related Hospitalizations is defined as hospitalization with reason for hospitalization related to CD.
Measured: 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)
Incidence Rate of CD-related Surgical Procedures compared between VDZ and UST cohorts
Incidence rate of CD-related surgical procedures will be measured in per 100 person-years. 100 person-years will be used as it is a method that can account for large among-participant variations in follow-up time. CD-related surgical procedures are defined as types of surgeries that are related to CD.
Measured: 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)
Incidence Rate of Disease Exacerbations Compared Between VDZ and UST Cohorts
Incidence rate of disease exacerbations will be measured in per 100 person-years. 100 person-years will be used as it is a method that can account for large among-participant variations in follow-up time. Exacerbations are defined as disease flares documented in the participant's medical chart.
Measured: 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)
Time to Treatment Switching of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Subsequent line treatment is defined as biologic and advanced therapy regimen(s) for participants who discontinued biologic vedolizumab or ustekinumab and initiated one or more biologic and advanced therapies, post-index treatment discontinuation.
Measured: 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)
Time to Treatment Discontinuation of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Subsequent line treatment is defined as biologic and advanced therapy regimen(s) for participants who discontinued biologic vedolizumab or ustekinumab and initiated one or more biologic and advanced therapies, post-index treatment discontinuation.
Measured: 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)
Time to Dose Escalation of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Subsequent line treatment is defined as biologic and advanced therapy regimen(s) for participants who discontinued biologic vedolizumab or ustekinumab and initiated one or more biologic and advanced therapies, post-index treatment discontinuation.
Measured: 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)
Cumulative Rates of Clinical Response of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Clinical response defined as CDAI positive change in score from baseline, if unknown, HBI overall score decrease >=3 points from baseline, if unknown, mHBI score decrease >=3 points from baseline, if unknown, changes in CRP, FCP, albumin or treatment response as complete response/partial response. CDAI score <150 indicates quiescent disease, >450 indicates extremely severe disease. HBI includes general well-being, abdominal pain, number of liquid stools per day, abdominal mass, complications. mHBI includes general well-being, abdominal pain, number of liquid stools/day, additional manifestation. HBI and mHBI total score is sum of individual parameters, score ranges 0 to no pre-specified maximum score, as it depends on number of liquid stools, higher scores means severe disease. Subsequent line treatment: biologic and advanced therapy regimen for participants who discontinued biologic VDZ and UST, initiated 1 or more biologic, advanced therapies, post-index treatment discontinuation.
Measured: 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)
Cumulative Rates of Clinical Remission of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Clinical remission defined as CDAI score <150 points, or if unknown, HBI Overall score of <=4 points, or if unknown, mHBI score of <=4 points, or if unknown, changes in CRP, FCP, and albumin or remission status recorded in the medical chart as 'in remission'. CDAI score <150 indicates quiescent disease and >450 indicates extremely severe disease. HBI includes: general well-being, abdominal pain, number of liquid stools/day, abdominal mass, complications. mHBI includes- general well-being, abdominal pain, number of liquid stools/day and additional manifestation. HBI and mHBI total score will be sum of individual parameters, score ranges 0 to no pre-specified maximum score as it depends on number of liquid stools, where higher scores is more severe disease. Subsequent line treatment is defined as biologic and advanced therapy regimen(s) for participants who discontinued biologic VDZ or UST and initiated one or more biologic and advanced therapies, post-index treatment discontinuation.
Measured: 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)
Cumulative Rates of Mucosal Healing of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Mucosal healing defined as endoscopic score = 0 or 1 (normal or inactive disease or mild disease), or if unknown, Simple Endoscopic Score for Crohn's Disease [SES-CD] score of <3, 'lack of ulceration' defined by one or more of following endoscopic procedure findings either selection of 'no ulcers' or free-text indication of 'lack of ulceration', or if unknown, one or more endoscopic procedure findings: inactive disease (no findings/no active disease, no erosion, no ulcers, no inflammation or inflammatory activity, or no pathological findings), higher scores more severe disease. Score for each endoscopic variable is sum of values obtained for each segment. SES-CD total is sum endoscopic variable scores: 0 to 56, higher scores indicate more severe disease. Subsequent line treatment is defined as biologic and advanced therapy regimen(s) for participants who discontinued biologic VDZ or UST and initiated one or more biologic and advanced therapies, post-index treatment discontinuation.
Measured: 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)
Cumulative Rates of Deep Remission of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Deep remission (clinical remission and mucosal healing) is defined as CDAI score <150 and SES-CD score <3. CDAI is scoring system for the assessment of CD activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease. The SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of the surface area affected, and stenosis in 5 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease. Subsequent line treatment is defined as biologic and advanced therapy regimen(s) for participants who discontinued biologic vedolizumab or ustekinumab and initiated one or more biologic and advanced therapies, post-index treatment discontinuation.
Measured: 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)
Cumulative Rates of Corticosteroid (CS)-free Remission of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
CS-free remission is defined as participants using oral corticosteroids at baseline. Subsequent line treatment is defined as biologic and advanced therapy regimen(s) for participants who discontinued biologic vedolizumab or ustekinumab and initiated one or more biologic and advanced therapies, post-index treatment discontinuation.
Measured: 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)
Cumulative Rates of CS-free Response of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Corticosteroid-free response is defined as participants using oral corticosteroids at baseline. Subsequent line treatment is defined as biologic and advanced therapy regimen(s) for participants who discontinued biologic vedolizumab or ustekinumab and initiated one or more biologic and advanced therapies, post-index treatment discontinuation.
Measured: 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)
Incidence Rate of AEs of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Incidence rate of AE will be measured in per 100 person-years. 100 person-years will be used as it is a method that can account for large among-participant variations in follow-up time. Subsequent line treatment is defined as biologic and advanced therapy regimen(s) for participants who discontinued biologic vedolizumab or ustekinumab and initiated one or more biologic and advanced therapies, post-index treatment discontinuation.
Measured: 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)
Incidence Rate of SAEs of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Incidence rate of SAEs will be measured in per 100 person-years. 100 person-years will be used as it is a method that can account for large among-participant variations in follow-up time. SAE is defined as an AE that either results in death, was a life threatening event), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event in the opinion of the physician. Subsequent line treatment is defined as biologic and advanced therapy regimen(s) for participants who discontinued biologic vedolizumab or ustekinumab and initiated one or more biologic and advanced therapies, post-index treatment discontinuation.
Measured: 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)
Incidence Rate of SIs of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Incidence rate of SIs will be measured in per 100 person-years. 100 person-years will be used as it is a method that can account for large among-participant variations in follow-up time. SI is defined as an SAE that is an infection. Subsequent line treatment is defined as biologic and advanced therapy regimen(s) for participants who discontinued biologic vedolizumab or ustekinumab and initiated one or more biologic and advanced therapies, post-index treatment discontinuation.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start1 Dec 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 623 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056441
- Sponsor's protocol ID
- Vedolizumab-5066
- Acronym
- EVOLVE
- Status last verified
- Oct 2022
- First submitted
- 27 Aug 2021
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Ferrante M, Christensen B, Bressler B, Brett NR, Bassel M, Kamble P, Adsul S, Gianchetti L, Scharl M. Real-World Effectiveness and Safety of Vedolizumab and Ustekinumab in Biologic-Naive Patients With Crohn's Disease: Results From the EVOLVE Expansion Chart Review Study. J Clin Gastroenterol. 2026 Feb 24. doi: 10.1097/MCG.0000000000002350. Online ahead of print.
PubMed 41729856Christensen 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.
PubMed 40641824
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENTYVIO® Real-World Outcomes in Bio-naïve Crohn's Disease Patients in Belgium, Australia, and Switzerland: An EVOLVE Observational Expansion Study
- ClinicalTrials.gov ID
- NCT05056441
- Acronym / sponsor ID
- EVOLVE / Vedolizumab-5066
- Conditions
- Crohn Disease
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 623 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 24 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Biologic-naïve CD participants who initiated biologic treatment with vedolizumab or ustekinumab (index event) during the eligibility period.
Key inclusion criteria (4 listed)
- Has a diagnosis of CD documented in the medical records.
- Has received at least one dose of vedolizumab or ustekinumab at one of the participating study sites during the eligibility period.
- Was biologic-naïve (no prior biologic use for any pathology, including CD) at the time of index event.
- 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.
Key exclusion criteria (6 listed)
- Has received vedolizumab or ustekinumab as part of a clinical trial in their lifetime (includes index event).
- Has initiated index treatment as combination therapy with two biologic agents.
- Has received previous treatment with biologic agents for CD or conditions other than CD ever in their lifetime.
- Has medical chart empty or missing.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cumulative Rates of Clinical Remission Over 36 Months Compared Between VDZ and UST Cohorts
Time frame: Baseline up to 36 months post-index date
Clinical remission will be defined as Crohn's Disease Activity Index (CDAI) score less than (<) 150 points, or if unknown, Harvey-Bradshaw Index (HBI) Overall score less than or equal to (<=) 4 points, or if unknown, Modified HBI (mHBI) score <=4 points, or if unknown, changes in biomarker assessments (C-reactive Protein, Fecal Calprotectin, and albumin) or remission status recorded in medical chart as 'in remission'. CDAI score <150 indicates quiescent disease and >450 indicates extremely severe disease. HBI consisted of 5 clinical parameters: general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications. mHBI consisted of 4 clinical parameters- general well-being, abdominal pain, number of liquid stools per day and additional manifestation. HBI and mHBI total score will be sum of individual parameters, score ranges 0 to no pre-specified maximum score as it depends on number of liquid stools, where higher scores is more severe disease.
28 secondary outcomes
Cumulative Rates of Clinical Response Over 36 Months Compared Between VDZ and UST Cohorts
Time frame: Baseline up to 36 months post-index date
Cumulative Rates of Clinical Remission Over 30 Months Compared Between VDZ and UST Cohorts
Time frame: Baseline up to 30 months post-index date
Cumulative Rates of Mucosal Healing Over 36 Months Compared Between VDZ and UST Cohorts
Time frame: Baseline up to 36 months post-index date
Cumulative Rates of Deep Remission Over 36 Months Compared Between VDZ and UST Cohorts
Time frame: Baseline up to 36 months post-index date
Cumulative Rates of Corticosteroid (CS)-free Remission Over 36 Months Compared Between VDZ and UST Cohorts
Time frame: Baseline up to 36 months post-index date
Cumulative Rates of CS-free Response Over 36 Months Compared Between VDZ and UST Cohorts
Time frame: Baseline up to 36 months post-index date
Time to Treatment Switching Compared Between VDZ and UST Cohorts
Time frame: From index event up to a maximum of 36 months post-index date
Time to Treatment Discontinuation Compared Between VDZ and UST Cohorts
Time frame: From index event up to a maximum of 36 months post-index date
Time to Dose Escalation Compared Between VDZ and UST Cohorts
Time frame: From index event up to a maximum of 36 months post-index date
Incidence Rate of Adverse Events (AEs) Compared Between VDZ and UST Cohorts
Time frame: 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)
Incidence Rate of Serious Adverse Events (SAEs) Compared Between VDZ and UST Cohorts
Time frame: 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)
Incidence Rate of Serious Infections (SIs) Compared Between VDZ and UST Cohorts
Time frame: 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)
Incidence Rate of Emergency Department (ED) Visits Compared Between VDZ and UST Cohorts
Time frame: 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)
Incidence Rate of CD-related Hospitalizations Compared Between VDZ and UST Cohorts
Time frame: 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)
Incidence Rate of CD-related Surgical Procedures compared between VDZ and UST cohorts
Time frame: 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)
Incidence Rate of Disease Exacerbations Compared Between VDZ and UST Cohorts
Time frame: 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)
Time to Treatment Switching of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Time frame: 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)
Time to Treatment Discontinuation of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Time frame: 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)
Time to Dose Escalation of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Time frame: 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)
Cumulative Rates of Clinical Response of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Time frame: 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)
Cumulative Rates of Clinical Remission of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Time frame: 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)
Cumulative Rates of Mucosal Healing of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Time frame: 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)
Cumulative Rates of Deep Remission of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Time frame: 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)
Cumulative Rates of Corticosteroid (CS)-free Remission of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Time frame: 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)
Cumulative Rates of CS-free Response of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Time frame: 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)
Incidence Rate of AEs of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Time frame: 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)
Incidence Rate of SAEs of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Time frame: 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)
Incidence Rate of SIs of Subsequent Line Treatments Compared Between VDZ and UST Cohorts
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
- Derived from this study: PubMed 41729856Ferrante M, Christensen B, Bressler B, Brett NR, Bassel M, Kamble P, Adsul S, Gianchetti L, Scharl M. Real-World Effectiveness and Safety of Vedolizumab and Ustekinumab in Biologic-Naive Patients With Crohn's Disease: Results From the EVOLVE Expansion Chart Review Study. J Clin Gastroenterol. 2026 Feb 24. doi: 10.1097/MCG.0000000000002350. Online ahead of print.
- Derived from this study: PubMed 40641824Christensen 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.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
31 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by Takeda at 31 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Australia, Belgium, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Rates of Clinical Remission Over 36 Months Compared Between VDZ and UST Cohorts (time frame: Baseline up to 36 months post-index date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05056441, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2022.