Study Stopped
Business Decision (no enrollment)
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
3 other identifiers
observational
N/A
1 country
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2020
Typical duration for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2020
CompletedFirst Posted
Study publicly available on registry
April 16, 2020
CompletedStudy Start
First participant enrolled
September 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedOctober 6, 2020
October 1, 2020
2.2 years
April 14, 2020
October 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (22)
Change From Baseline in HBI at Month 12
Baseline up to Month 12
Change From Baseline in Physician Global Assessment (PGA) at Month 12
Baseline up to Month 12
Change From Baseline in Patient-reported Outcome (PRO) Using the Two-item (PRO-2) at Month 12
Baseline and Month 12
Change From Baseline in C-reactive Protein (CRP) Level at Month 12
Baseline and Month 12
Percentage of Participants in Remission as Determined by CRP Measurements <5 Milligram per Liter (mg/L) at Month 12
Month 12
- +17 more secondary outcomes
Study Arms (1)
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.
Eligibility Criteria
Biologic-naive participants diagnosed with moderately to severely active CD who have initiated treatment with vedolizumab under standard clinical care will be observed.
You may qualify if:
- Is enrolled in Takeda's participant support program prior to receiving vedolizumab.
- Has a diagnosis of moderately-to-severely active CD, as documented in the medical records.
- Scheduled for initial vedolizumab treatment per usual care recommendation.
- Was biologic-naive at time of initiating vedolizumab treatment.
You may not qualify if:
- Was prescribed vedolizumab as part of a clinical study.
- Has isolated and active perianal disease in the absence of luminal CD.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (14)
Kelowna GI Associates
Kelowna, British Columbia, V1Y 6J6, Canada
Fraser Clinical Trials Inc.
New Westminster, British Columbia, V3L 3W4, Canada
The Winnipeg Clinic
Winnipeg, Manitoba, R3C 0N2, Canada
REGIONAL HEALTH AUTHORITY B doing business as HORIZON HEALTH NETWORK
Fredericton, New Brunswick, E3B 4R3, Canada
Nova ScotiaHealth Authority
Halifax, Nova Scotia, B3V 1V7, Canada
Barrie GI Associates
Barrie, Ontario, L4M 7G1, Canada
Lawson Health Research Institute a joint venture of London Health Science Centre Research Inc., Lawson Research Institute.
London, Ontario, N6C 2R5, Canada
Girish Bajaj MPC
Oakville, Ontario, L6H 7v7, Canada
Sinai Health System
Toronto, Ontario, M5G 1X5, Canada
Kensington Cancer Screening Clinic
Toronto, Ontario, M5T 3A9, Canada
Toronto Immune and Digestive Health Institute
Toronto, Ontario, M6A 3B4, Canada
Research Institute McGill University Health Centre (RI-MUHC)
Montreal, Quebec, H3G 1A4, Canada
Centre integre universitaire de sante et de services sociaux de l'Estrie Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1G 2E8, Canada
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Takeda
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2020
First Posted
April 16, 2020
Study Start
September 30, 2020
Primary Completion
November 30, 2022
Study Completion
November 30, 2022
Last Updated
October 6, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will share
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.