ENTYVIO in Bio-naive Patients With Moderate/Severe Crohn's Disease (CD) in Daily Practice (EARLY-CD)

A Prospective Observational Study of ENTYVIO Management in Crohn's Disease in Canada: Real-World Experience and Patient-Reported Outcomes

The purpose of this study is to describe physician-reported clinical effectiveness outcomes, as determined by Harvey-Bradshaw Index (HBI) assessment, in biologic-naive participants with CD over 12 months following treatment initiation with vedolizumab.

Study Overview

• Status: Withdrawn
• Conditions: Crohn Disease

Detailed Description

This is a non-interventional, single-cohort, prospective study of participants with moderate to severe CD. The study will review medical charts with prospective patient-reported outcome measures to provide real-world data to describe clinical outcomes and participant-reported symptom experience over 12 months following vedolizumab treatment initiation.

The study will enroll approximately 140 participants. All participants will be enrolled in one observational group:

• Vedolizumab

This multicenter trial will be conducted in Canada. The overall duration of study will be approximately 24 months, including participant's enrolment period of 12 months and follow-up data collection period of 12 months.

• Study Type: Observational

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 6J6
      • Kelowna GI Associates
    • New Westminster, British Columbia, Canada, V3L 3W4
      • Fraser Clinical Trials Inc.
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3C 0N2
      • The Winnipeg Clinic
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 4R3
      • REGIONAL HEALTH AUTHORITY B doing business as HORIZON HEALTH NETWORK
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3V 1V7
      • Nova ScotiaHealth Authority
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • Barrie GI Associates
    • London, Ontario, Canada, N6C 2R5
      • Lawson Health Research Institute a joint venture of London Health Science Centre Research Inc., Lawson Research Institute.
    • Oakville, Ontario, Canada, L6H 7v7
      • Girish Bajaj MPC
    • Toronto, Ontario, Canada, M5G 1X5
      • Sinai Health System
    • Toronto, Ontario, Canada, M5T 3A9
      • Kensington Cancer Screening Clinic
    • Toronto, Ontario, Canada, M6A 3B4
      • Toronto Immune and Digestive Health Institute
  • Quebec
    • Montreal, Quebec, Canada, H3G 1A4
      • Research Institute McGill University Health Centre (RI-MUHC)
    • Sherbrooke, Quebec, Canada, J1G 2E8
      • Centre integre universitaire de sante et de services sociaux de l'Estrie Centre hospitalier universitaire de Sherbrooke
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • University of Saskatchewan

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

Biologic-naive participants diagnosed with moderately to severely active CD who have initiated treatment with vedolizumab under standard clinical care will be observed.

Description

Inclusion Criteria:

1. Is enrolled in Takeda's participant support program prior to receiving vedolizumab.
2. Has a diagnosis of moderately-to-severely active CD, as documented in the medical records.
3. Scheduled for initial vedolizumab treatment per usual care recommendation.
4. Was biologic-naive at time of initiating vedolizumab treatment.

Exclusion Criteria:

1. Was prescribed vedolizumab as part of a clinical study.
2. Has isolated and active perianal disease in the absence of luminal CD.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Vedolizumab Participants; Participants diagnosed with moderate to severe CD from approximately 20 investigational sites will be observed over a period of 12 months after initiation of treatment with vedolizumab, intravenous infusion under standard clinical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants in Clinical Remission at Month 12	Clinical remission is defined as HBI less than or equal to (<=) 5. HBI score is used to measure disease activity of CD. It consists of clinical parameters: general well-being (0= very well to 4= terrible), abdominal pain (0=none to 3= severe), number of liquid or soft stools/ previous day, abdominal mass (0= none to 3= definite and tender), and complications (8 items; 1 score/item). The total score is sum of sub scores, where score <5 = remission, 5 to 7 = mild disease activity, 8 to 16 = moderate disease activity and greater than (>) 16 = severe disease activity.	Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in HBI at Month 12	HBI score is used to measure disease activity of CD. It consists of clinical parameters: general well-being (0= very well to 4= terrible), abdominal pain (0=none to 3= severe), number of liquid or soft stools/previous day, abdominal mass (0= none to 3= definite and tender), and complications (8 items; 1 score/item). The total score is sum of sub scores, where score <5 = remission, 5 to 7 = mild disease activity, 8 to 16 = moderate disease activity and >16 = severe disease activity.	Baseline up to Month 12
Change From Baseline in Physician Global Assessment (PGA) at Month 12	PGA score is used to measure disease activity of CD. Score ranges from 0 to 3, where 0 = normal condition; 1- mild disease condition; 2= moderate disease condition; and 3 = severe disease condition.	Baseline up to Month 12
Change From Baseline in Patient-reported Outcome (PRO) Using the Two-item (PRO-2) at Month 12	The PRO2 is comprised of the stool frequency and abdominal pain components of the Crohn's Disease Activity Index (CDAI). The PRO-2 score is the sum of the abdominal pain and stool frequency subscores of the CDAI score. The average daily number of stools and abdominal pain score (with 0 indicating no pain and 4 indicating severe pain) over the past seven days are weighted according to the CDAI multiplication factors (2 for stool frequency and 5 for abdominal pain).	Baseline and Month 12
Change From Baseline in C-reactive Protein (CRP) Level at Month 12	Comparison of absolute change in CRP from baseline to Month 12. CRP is produced by the liver. The level of CRP rises when there is inflammation throughout the body.	Baseline and Month 12
Percentage of Participants in Remission as Determined by CRP Measurements <5 Milligram per Liter (mg/L) at Month 12	Remission is defined as CRP <5 mg/L.	Month 12
Change From Baseline in Fecal Calprotectin (FCP) Levels at Month 12		Baseline and Month 12
Percentage of Participants in Remission as Determined by FCP Measurements (FCP < 50 milligram per kilogram [mg/Kg]) at Month 12	Remission is defined as FCP <50 mg/kg.	Month 12
Percentage of Participants With Endoscopic Improvement at Month 12 as Determined by Simple Endoscopic Score for Crohn's Disease (SES-CD) Values or Qualitative Physician Assessment of Disease Severity	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 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is 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. The Physician's Assessment of Disease Severity was ranked on a 9-point scale (9 = much worse, 7 = worse, 5 = no change, 3 = better, 1 = much better).	Baseline and Month 12
Number of Participants Categorized by Participant Demographics, Clinical Characteristics and Disease Phenotype		Month 12
Change From Baseline in Work Productivity and Activity Impairment Specific Health Problem (WPAI-SHP) Score at Month 12	The WPAI-SHP assess the impact of CD on work productivity and daily activities, and classroom impairment during the previous 7 days. The questionnaire consists of questions about the number of hours missed from work, hours worked, and the extent to which work productivity and regular daily activities were affected. Scores will be calculated as percentages of hours worked and percentages of productivity at work on work days. An overall work productivity score will be computed by multiplying the percentage of work time by the percentage productivity at work; the higher the scores, the better work productivity and activity performance.	Baseline, Month 12
Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score at Month 12	The SIBDQ is a self-reported quantitative assessment of participant's health-related quality of life (HRQoL) in terms of physical, emotional, and social symptoms associated with IBD. The questionnaire relates to the past two weeks and consists of 10 questions about fatigue, social and leisure activities, pain, feelings of depression, and physical health issues. It consists of 7 point scale, with 1 indicating severity and 7 indicating the lack of a problem. The overall score can range from 10-70, with higher scores signifying better HRQoL.	Baseline and Month 12
Change From Baseline in Corticosteroid Dose at Month 12		Baseline and Month 12
Change From Baseline in Immunomodulator Dose at Month 12		Baseline and Month 12
Change From Baseline in the Percentage of Participants That are Steroid-free at Month 12		Baseline and Month 12
Change From Baseline in the Percentage of Participants That are Immunomodulator-free at Month 12		Baseline and Month 12
Number of Participants with Reporting one or More Adverse Events and Serious Adverse Events (SAEs)		Baseline up to Month 12
Number of Participants Based on CD-related Emergency Room (ER) Visits, Hospitalizations, or Surgeries		Baseline up to Month 12
Number of Participants that initiated Vedolizumab treatment and are still on Vedolizumab treatment at 12 months of follow-up		Baseline up to Month 12
Number of Participants With Reasons for Discontinuation of Vedolizumab Treatment		Baseline up to Month 12
Number of Participants Based on Subsequent Biologic Therapy Type		Baseline up to Month 12
Number of Participants that Received vedolizumab Dose Optimization	Dose optimization is defined as a change from every 8 weeks maintenance vedolizumab to any other schedule.	Baseline up to Month 12
Time to vedolizumab Dose Optimization	Dose optimization is defined as a change from every 8 weeks maintenance vedolizumab to any other schedule.	Baseline up to Month 12

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start (Anticipated): September 30, 2020
• Primary Completion (Anticipated): November 30, 2022
• Study Completion (Anticipated): November 30, 2022

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (Actual): April 16, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2020
• Last Update Submitted That Met QC Criteria: October 2, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: Vedolizumab-4022; U1111-1217-6862 (Registry Identifier: WHO); MACS-2017-102118 (Other Identifier: Study ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Drug and device information, study documents

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