A Study to Observe Vedolizumab and Anti-tumour Necrosis Factors (Anti-TNFs) Outcomes in Real-world Biologic Ulcerative Colitis (UC) and Crohn's Disease (CD) Participants (EVOLVE-IBERIA)

Vedolizumab and Anti-TNFs Outcomes in Real-World Biologic Ulcerative Colitis and Crohn's Disease Patients

The purpose of this study is to describe treatment patterns associated with first-line and second line biologic use (vedolizumab or other biologic) and to describe the real-world clinical effectiveness of the use (first-line and second line) vedolizumab versus other biologics at least 6 months post-treatment initiation.

Study Overview

• Status: Completed
• Conditions: Crohn Disease; Colitis, Ulcerative

Detailed Description

This is a retrospective, non-interventional study of participants with CD or UC. The study will review the medical charts of participants who have initiated the first or second line treatment with vedolizumab or another biologic agent (infliximab, adalimumab, or golimumab [UC only]) (index event) during the eligibility period to evaluate the treatment effectiveness, treatment patterns, health care utilization and safety of vedolizumab, and to provide the real-world treatment landscape with anti-TNF alpha therapies.

The study will enroll approximately 400 participants, with 200 participants in each treatment cohort. All participants will be enrolled into two observational groups:

• Cohort 1: Vedolizumab
• Cohort 2: Other Biologics

The data for participants will be collected in two main periods:

• Pre-index Event Period: From the data of diagnosis of UC/CD until one day prior to the date when vedolizumab or other biologic treatment was initiated during the eligibility period.
• Post-index Event Period: From the date when vedolizumab or other biologic treatment was initiated during the eligibility period until the earliest of 6 months (post-index treatment discontinuation, death of participants, lost-to-follow up, or date of chart abstraction initiation.

This multi-center trial will be conducted in Spain and Portugal. The overall time for data collection in the study will be approximately 12 months and the overall duration of the study is approximately 24 months.

• Study Type: Observational
• Enrollment (Actual): 409

Contacts and Locations

Study Locations

• Portugal
  • Evora, Portugal, 7000-811
    • Hospital do Espirito Santo de Evora
  • Lisboa, Portugal, 1649-028
    • Centro Hospitalar Universitário Lisboa Norte - Hospital De Santa Maria
  • Santarem, Portugal, 2005-177
    • Hospital Distrital de Santarém
  • Aveiro
    • Santa Maria da Feira, Aveiro, Portugal, 4520-211
      • Centro Hospitalar de Entre Douro e Vouga
  • Lisboa
    • Loures, Lisboa, Portugal, 2674-514
      • Hospital Beatriz Angelo
• Spain
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • Hospital Universitario Central de Asturias (HUCA)
  • Castilla Y Leon
    • Leon, Castilla Y Leon, Spain, 24071
      • Hospital Universitario de Leon
    • Salamanca, Castilla Y Leon, Spain, 37007
      • Hospital Universitario de Salamanca
  • Cataluna
    • Barcelona, Cataluna, Spain, 08035
      • Hospital Vall d'Hebron
    • Barcelona, Cataluna, Spain, 08041
      • Hospital de la Santa Creu i Sant Pau
    • Barcelona, Cataluna, Spain, 08208
      • Hospital Universitari Parc Tauli
    • Barcelona, Cataluna, Spain, 08970
      • Hospital de Sant Joan Despí - Moises Broggi
    • Girona, Cataluna, Spain, 17007
      • Hospital Universitari de Girona Doctor Josep Trueta
  • Comunidad De Madrid
    • Madrid, Comunidad De Madrid, Spain, 28040
      • Hospital Clinico San Carlos
    • Madrid, Comunidad De Madrid, Spain, 28006
      • Hospital de La Princesa
    • Madrid, Comunidad De Madrid, Spain, 28007
      • Hospital General Universitario Gregorio Marañon
    • Madrid, Comunidad De Madrid, Spain, 28041
      • Hospital Universitario 12 de Octubre
    • Madrid, Comunidad De Madrid, Spain, 28046
      • Hospital Universitario de La Paz
    • Madrid, Comunidad De Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro
  • Comunidad Valenciana
    • Alicante, Comunidad Valenciana, Spain, 03010
      • Hospital General Universitario de Alicante
    • Valencia, Comunidad Valenciana, Spain, 46010
      • Hospital Clinico Universitario de Valencia
    • Valencia, Comunidad Valenciana, Spain, 46026
      • Hospital Universitario y Politecnico La Fe
    • Valencia, Comunidad Valenciana, Spain, 46940
      • Hospital de Manises
  • Islas Baleares
    • Palma, Islas Baleares, Spain, 07120
      • Hospital Universitari Son Espases
  • Islas Canarias
    • Santa Cruz de Tenerife, Islas Canarias, Spain, 38320
      • Hospital Universitario de Canarias
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Hospital de Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants diagnosed with moderate to severe UC or CD, and have initiated first or second line treatment with vedolizumab and other biologics between January 2017 and the date of site initiation.

Description

Inclusion Criteria:

1. Has a diagnosis of moderate to severe UC or CD documented in the medical chart.
2. Received at least one dose of vedolizumab or other biologic (infliximab, adalimumab, or golimumab [UC only]) during the eligibility period.
3. Received the biologic treatment as first-line or second line biologic for UC or CD.
4. Has a minimum of six months of follow-up between date of starting biologic therapy (index event) and the date of completion of the participant pre-selection registry.

Exclusion Criteria:

1. Received vedolizumab or another biologic as part of an interventional clinical trial ever in their lifetime (includes index treatment).
2. Index treatment was another biologic therapy other than vedolizumab, infliximab, adalimumab, or golimumab (UC only).
3. Initiated index treatment as combination therapy with two biologic agents.
4. The biologic was prescribed for treatment of perianal disease.
5. Received biologic therapy before the index period for a disease other than inflammatory bowel disease.
6. Medical chart is unavailable.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cohort 1: Vedolizumab; Participants diagnosed with UC or CD, who have initiated vedolizumab treatment between January 2017 until date of site initiation from the 25 participating sites will be observed from the date of UC or CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date is defined as the date when vedolizumab treatment was initiated.
Cohort 2: Other Biologic; Participants diagnosed with UC or CD, who have initiated other biologic treatment (infliximab, adalimumab, or golimumab [UC only]) between January 2017 until date of site initiation from the 25 participating sites will be observed from the date of UC or CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date is defined as the date when other biologic treatment was initiated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Change in Dose and Frequency of Dose Intervals		From the index date up to treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)
Number of Participants With Treatment Modifications	Reasons for treatment modification will be related to adverse event (AE) versus related to disease management.	From the index date up to treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)
Number of Participants With Non-biological Concomitant Drug Treatment	Concomitant drug treatment will include prescribed non-biological drug therapy during post-index period. Index date is defined as the date when vedolizumab or other biologics treatment was initiated.	From the index date up to treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)
Number of Participants who Discontinued Index Therapy		From the index date up to treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)
Number of Participants who Discontinued Index Therapy With Subsequent Implementation of Another Biologic Therapy	Another biologic therapy will include either vedolizumab, infliximab, adalimumab, or golimumab (UC only), tofacitinib, certolizumab and ustekinumab.	From the index date up to treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)
Time to Switching	Time to switching is defined as time from index treatment initiation until a participant initiates another biologic treatment (vedolizumab, infliximab, adalimumab, or golimumab [UC only], tofacitinib, certolizumab and ustekinumab).	From index date up to initiation of another biological treatment (approximately 6 months post index date)
Time to Discontinuation	Time to discontinuation is defined as time from index treatment initiation until participant discontinues index treatment without switching to another biologic therapy.	From index date up to discontinuation of index treatment without switching to another biologic therapy (approximately 6 months post index date)
Change From Baseline in Mayo Score at Month 6	Mayo score is an instrument designed to measure disease activity of UC. Complete Mayo score consists of 4 sub-scores: stool pattern, most severe rectal bleeding of the day, endoscopic findings and global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 12. Partial Mayo score consists of 3 sub-scores: stool pattern, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Here, higher scores indicates more severe disease.	Baseline and Month 6 post-index date
Change From Baseline in Simple Endoscopic Index for Crohn's Disease (SES-CD) at Month 6	The SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of the surface area that is ulcerated, percentage of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.	Baseline and Month 6 post-index date
Change From Baseline in Harvey Bradshaw Index (HBI) Score at Month 6	HBI score is used to measure the disease activity of CD. It consists of clinical parameters: general well-being (0-4, where higher score means lower wellbeing), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools, where higher scores indicating more severe disease.	Baseline and Month 6 post-index date
Change From Baseline in Crohn's disease active index (CDAI) Score at Month 6	CDAI assesses CD based on clinical signs and symptoms such as number of liquid stools, intensity of abdominal pain, general well being, presence of comorbid conditions, use of antidiarrheal, physical examination and laboratory findings. Total score ranges from 0 to 600 points. Higher score indicates more severe disease. HBI consists of 5 clinical parameters: general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications. Total score is sum of individual parameters. Score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on number of liquid stools, where higher scores indicates more severe disease.	Baseline and Month 6 post-index date
Number of Participants With Change From baseline in C-reactive Protein (CRP) Level		Baseline and Month 6 post-index date
Number of Participants With Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Level		Baseline and Month 6 post-index date
Number of Participants With Change From Baseline in Fecal Calprotectin (FCP) Level		Baseline and Month 6 post-index date
Number of Participants With Change From Baseline in Endoscopic Findings		Baseline and Month 6 post-index date

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Mayo Score at Month 12	Mayo score is an instrument designed to measure disease activity of UC. Complete Mayo score consists of 4 sub-scores: stool pattern, most severe rectal bleeding of the day, endoscopic findings and global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 12. Partial Mayo score consists of 3 sub-scores: stool pattern, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Here, higher scores indicates more severe disease.	Baseline and Month 12 post-index date
Change From Baseline in SES-CD at Month 12	The SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of the surface area that is ulcerated, percentage of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.	Baseline and Month 12 post-index date
Change From Baseline in HBI Score at Month 12	HBI score is used to measure the disease activity of CD. It consists of clinical parameters: general well-being (0-4, where higher score means lower wellbeing), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools, where higher scores indicating more severe disease.	Baseline and Month 12 post-index date
Change From Baseline in CDAI Score at Month 12	CDAI assesses CD based on clinical signs and symptoms such as number of liquid stools, intensity of abdominal pain, general wellbeing, presence of comorbid conditions, use of antidiarrheal, physical examination and laboratory findings. Total score ranges from 0 to 600 points. Higher score indicates more severe disease. HBI consists of 5 clinical parameters: general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications. Total score is sum of individual parameters. Score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on number of liquid stools, where higher scores indicates more severe disease.	Baseline and Month 12 post-index date
Number of Participants with Change from Baseline in CRP Level, ESR Level, and FCP Level at Month 12		Baseline and Month 12 post-index date
Number of Participants with Change From Baseline in Endoscopic Findings		Baseline and Month 12 post-index date
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Non-Treatment Related Events		Baseline up to Month 6 post-index date
Number of Participants With Non-serious Adverse Events and Serious Adverse Events (SAEs) Related to Treatment		Baseline up to Month 6 post-index date
Number of Participants With Treatment Alterations due to AEs	Treatment alterations include the factors like treatment withdrawn, treatment reduced, treatment delayed or treatment increased.	Baseline up to Month 6 post-index date
AE Duration	AE duration is defined as date of onset of an AE till date of resolution.	From start of an AE up to AE resolution (Approximately up to 6 months)
Number of Participants with AE Outcome		Baseline up to Month 6 post-index date

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2019
• Primary Completion (Actual): August 23, 2021
• Study Completion (Actual): February 21, 2022

Study Registration Dates

• First Submitted: October 16, 2018
• First Submitted That Met QC Criteria: October 16, 2018
• First Posted (Actual): October 18, 2018

Study Record Updates

• Last Update Posted (Actual): June 16, 2022
• Last Update Submitted That Met QC Criteria: June 15, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Crohn Disease; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: Vedolizumab-5047; U1111-1218-0768 (Registry Identifier: WHO); TAK-VDZ-2018-01 (Other Identifier: Spanish Agency for Medicine and Health Products)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No