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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05056441
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Takeda
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Study Director
Principal Investigator Affiliation Takeda
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Belgium, Switzerland
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

: 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.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Concord Repatriation General Hospital, Concord, New South Wales, Australia

Status

Not yet recruiting

Address

Concord Repatriation General Hospital

Concord, New South Wales, 2139

Site Contact

Site Contact

rupert.leong@health.nsw.gov.au

+61297676111

Liverpool Hospital, Liverpool, New South Wales, Australia

Status

Recruiting

Address

Liverpool Hospital

Liverpool, New South Wales, 2170

John Hunter Hospital, New Lambton, New South Wales, Australia

Status

Recruiting

Address

John Hunter Hospital

New Lambton, New South Wales, 2305

Site Contact

Site Contact

laytheng.gan@health.nsw.gov.au

+618888888888

Royal Brisbane & Women's Hospital, Herston, Queensland, Australia

Status

Not yet recruiting

Address

Royal Brisbane & Women's Hospital

Herston, Queensland, 4029

Mater Misericordiae Health Services, South Brisbane, Queensland, Australia

Status

Not yet recruiting

Address

Mater Misericordiae Health Services

South Brisbane, Queensland, 4101

Site Contact

Site Contact

yoon.an@mater.uq.edu.au

+61731638195

Integrated Gut Health Pty Ltd, Taringa, Queensland, Australia

Status

Recruiting

Address

Integrated Gut Health Pty Ltd

Taringa, Queensland, 4068

Royal Adelaide Hospital, Adelaide, South Australia, Australia

Status

Not yet recruiting

Address

Royal Adelaide Hospital

Adelaide, South Australia, 5000

Site Contact

Site Contact

kate.lynch@sa.gov.au

+61870742181

Lyell McEwin Hospital, Elizabeth Vale, South Australia, Australia

Status

Not yet recruiting

Address

Lyell McEwin Hospital

Elizabeth Vale, South Australia, 5112

Site Contact

Site Contact

derrick.tee@sa.gov.au

+618888888888

Monash Health, Monash Medical Centre, Clayton, Victoria, Australia

Status

Not yet recruiting

Address

Monash Health, Monash Medical Centre

Clayton, Victoria, 3168

Site Contact

Site Contact

gregory.moore@med.monash.edu.au

+61395943177

Royal Melbourne Hospital, East Melbourne, Victoria, Australia

Status

Recruiting

Address

Royal Melbourne Hospital

East Melbourne, Victoria, 3000

Site Contact

Site Contact

Britt.Christensen@mh.org.au

+61396507917

The Alfred Hospital, Melbourne, Victoria, Australia

Status

Recruiting

Address

The Alfred Hospital

Melbourne, Victoria, 3004

Site Contact

Site Contact

m.sparrow@alfred.org.au

+61398950369

Fiona Stanley Hospital, Murdoch, Western Australia, Australia

Status

Recruiting

Address

Fiona Stanley Hospital

Murdoch, Western Australia, 6150

Site Contact

Site Contact

lena.thin@health.wa.gov.au

+61403128519

St John of God Hospital Subiaco, Subiaco, Western Australia, Australia

Status

Recruiting

Address

St John of God Hospital Subiaco

Subiaco, Western Australia, 6008

Site Contact

Site Contact

ian.lawrance@uwa.edu.au

+61894313333

Imelda VZW, Bonheiden, Antwerpen, Belgium

Status

Recruiting

Address

Imelda VZW

Bonheiden, Antwerpen, 2820

Site Contact

Site Contact

lieven.pouillon@imelda.be

+3215505165

UZ Antwerpen, Edegem, Antwerpen, Belgium

Status

Not yet recruiting

Address

UZ Antwerpen

Edegem, Antwerpen, 2650

Site Contact

Site Contact

elisabeth.macken@uza.be

+3238213323

Hopital Erasme, Anderlecht, Brussels, Belgium

Status

Recruiting

Address

Hopital Erasme

Anderlecht, Brussels, 1070

Mons, Hainaut, Belgium

Status

Recruiting

Address

Centre Hospitalier Universitaire Ambroise Pare

Mons, Hainaut, 7000

Site Contact

Site Contact

frederic.flamme@hap.be

+3265392111

CHWAPI Tournai, Tournai, Hainaut, Belgium

Status

Recruiting

Address

CHWAPI Tournai

Tournai, Hainaut, 7500

Site Contact

Site Contact

antoine.nakad@chwapi.be

+3269258731

AZ Sint-Lucas, Gent, Oost-Vlaanderen, Belgium

Status

Recruiting

Address

AZ Sint-Lucas

Gent, Oost-Vlaanderen, 9000

Site Contact

Site Contact

harald.peeters@azstlucas.be

+3292246480

UZ Gent, Gent, Oost-Vlaanderen, Belgium

Status

Recruiting

Address

UZ Gent

Gent, Oost-Vlaanderen, 9000

Site Contact

Site Contact

triana.lobatonortega@uzgent.be

+3293325166

UZ Leuven, Leuven, Vlaams Brabant, Belgium

Status

Not yet recruiting

Address

UZ Leuven

Leuven, Vlaams Brabant, 3000

Site Contact

Site Contact

marc.ferrante@uzleuven.be

+3216344225

AZ Groeninge, Kortrijk, West-Vlaanderen, Belgium

Status

Recruiting

Address

AZ Groeninge

Kortrijk, West-Vlaanderen, 8500

AZ Delta, Roeselare, West-Vlaanderen, Belgium

Status

Recruiting

Address

AZ Delta

Roeselare, West-Vlaanderen, 8800

Site Contact

Site Contact

filip.baert@azdelta.be

+3251237215

CHU St-Pierre, Brussels, Belgium

Status

Recruiting

Address

CHU St-Pierre

Brussels, , 1000

Site Contact

Site Contact

vinciane_muls@stpierre-bru.be

+3225354217

Centre Hospitalier Chretien MontLegia, Liege, Belgium

Status

Recruiting

Address

Centre Hospitalier Chretien MontLegia

Liege, , 4000

Site Contact

Site Contact

arnaud.colard@chc.be

+3243554130

CHU de Liege, Liege, Belgium

Status

Recruiting

Address

CHU de Liege

Liege, , 4000

Site Contact

Site Contact

edouard.louis@uliege.be

+3243667869

Clarunis Bauchzenturm, Basel, Basel-Stadt (de), Switzerland

Status

Active, not recruiting

Address

Clarunis Bauchzenturm

Basel, Basel-Stadt (de), 4051

Inselspital Bern, Bern, Bern (de), Switzerland

Status

Not yet recruiting

Address

Inselspital Bern

Bern, Bern (de), 3010

Site Contact

Site Contact

benjamin.misselwitz@insel.ch

+41316325900

Bern, Bern (de), Switzerland

Status

Recruiting

Address

Intesto KLG Gastroenterologische Praxis Crohn-Colitis-Zentrum

Bern, Bern (de), 3012

Stadtspital Triemli Zurich, Zurich, Zurich (de), Switzerland

Status

Recruiting

Address

Stadtspital Triemli Zurich

Zurich, Zurich (de), 8063

Site Contact

Site Contact

stephan.vavricka@hin.ch

+41444163317

Universitatsspital Zurich, Zurich, Zurich (de), Switzerland

Status

Recruiting

Address

Universitatsspital Zurich

Zurich, Zurich (de), 8091

Site Contact

Site Contact

michael.scharl@usz.ch

+418888888888

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