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

NCT05056441 | Completed

• 1 other identifier: Vedolizumab-5066
• Study Type: observational
• Target: 623
• Locations: 3 countries
• Sites: 31

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.

Conditions

Crohn Disease

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Baseline up to 36 months post-index date

• Cumulative Rates of Clinical Remission Over 30 Months Compared Between VDZ and UST Cohorts

  Baseline up to 30 months post-index date

• Cumulative Rates of Mucosal Healing Over 36 Months Compared Between VDZ and UST Cohorts

  Baseline up to 36 months post-index date

• Cumulative Rates of Deep Remission Over 36 Months Compared Between VDZ and UST Cohorts

  Baseline up to 36 months post-index date

• Cumulative Rates of Corticosteroid (CS)-free Remission Over 36 Months Compared Between VDZ and UST Cohorts

  Baseline up to 36 months post-index date

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Takeda: lead

Study Sites (31)

Concord Repatriation General Hospital

Concord, New South Wales, 2139, Australia

Location

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

John Hunter Hospital

New Lambton, New South Wales, 2305, Australia

Location

Royal Brisbane & Women's Hospital

Herston, Queensland, 4029, Australia

Location

Mater Misericordiae Health Services

South Brisbane, Queensland, 4101, Australia

Location

Integrated Gut Health Pty Ltd

Taringa, Queensland, 4068, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Lyell McEwin Hospital

Elizabeth Vale, South Australia, 5112, Australia

Location

Monash Health, Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

Royal Melbourne Hospital

East Melbourne, Victoria, 3000, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

Location

St John of God Hospital Subiaco

Subiaco, Western Australia, 6008, Australia

Location

Imelda VZW

Bonheiden, Antwerpen, 2820, Belgium

Location

UZ Antwerpen

Edegem, Antwerpen, 2650, Belgium

Location

Hopital Erasme

Anderlecht, Brussels Capital, 1070, Belgium

Location

Centre Hospitalier Universitaire Ambroise Pare

Mons, Hainaut, 7000, Belgium

Location

CHWAPI Tournai

Tournai, Hainaut, 7500, Belgium

Location

AZ Sint-Lucas

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

UZ Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

UZ Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

AZ Groeninge

Kortrijk, West-Vlaanderen, 8500, Belgium

Location

AZ Delta

Roeselare, West-Vlaanderen, 8800, Belgium

Location

CHU St-Pierre

Brussels, 1000, Belgium

Location

Centre Hospitalier Chretien MontLegia

Liège, 4000, Belgium

Location

CHU de Liege

Liège, 4000, Belgium

Location

Clarunis Bauchzenturm

Basel, Basel-Stadt (de), 4051, Switzerland

Location

Inselspital Bern

Bern, Bern (de), 3010, Switzerland

Location

Intesto KLG Gastroenterologische Praxis Crohn-Colitis-Zentrum

Bern, Bern (de), 3012, Switzerland

Location

Stadtspital Triemli Zurich

Zurich, Zurich (de), 8063, Switzerland

Location

Universitatsspital Zurich

Zurich, Zurich (de), 8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 40641824 DERIVED

Related Links

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

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 24, 2021
• Study Start: December 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: October 21, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 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.

Locations

AU (13); BE (13); CH (5)