Clinical trial NCT04349449: ENTYVIO in Bio-naive Patients With Moderate/Severe Crohn's Disease (CD) in Daily Practice
Official title: A Prospective Observational Study of ENTYVIO Management in Crohn's Disease in Canada: Real-World Experience and Patient-Reported Outcomes
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Crohn Disease
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2020-04-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants in Clinical Remission at Month 12
timeFrame: Month 12
Secondary outcomes:
measure: Change From Baseline in HBI at Month 12
timeFrame: Baseline up to Month 12
measure: Change From Baseline in Physician Global Assessment (PGA) at Month 12
timeFrame: Baseline up to Month 12
measure: Change From Baseline in Patient-reported Outcome (PRO) Using the Two-item (PRO-2) at Month 12
timeFrame: Baseline and Month 12
measure: Change From Baseline in C-reactive Protein (CRP) Level at Month 12
timeFrame: Baseline and Month 12
measure: Percentage of Participants in Remission as Determined by CRP Measurements <5 Milligram per Liter (mg/L) at Month 12
timeFrame: Month 12
measure: Change From Baseline in Fecal Calprotectin (FCP) Levels at Month 12
timeFrame: Baseline and Month 12
measure: Percentage of Participants in Remission as Determined by FCP Measurements (FCP < 50 milligram per kilogram [mg/Kg]) at Month 12
timeFrame: Month 12
measure: 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
timeFrame: Baseline and Month 12
measure: Number of Participants Categorized by Participant Demographics, Clinical Characteristics and Disease Phenotype
timeFrame: Month 12
measure: Change From Baseline in Work Productivity and Activity Impairment Specific Health Problem (WPAI-SHP) Score at Month 12
timeFrame: Baseline, Month 12
measure: Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score at Month 12
timeFrame: Baseline and Month 12
measure: Change From Baseline in Corticosteroid Dose at Month 12
timeFrame: Baseline and Month 12
measure: Change From Baseline in Immunomodulator Dose at Month 12
timeFrame: Baseline and Month 12
measure: Change From Baseline in the Percentage of Participants That are Steroid-free at Month 12
timeFrame: Baseline and Month 12
measure: Change From Baseline in the Percentage of Participants That are Immunomodulator-free at Month 12
timeFrame: Baseline and Month 12
measure: Number of Participants with Reporting one or More Adverse Events and Serious Adverse Events (SAEs)
timeFrame: Baseline up to Month 12
measure: Number of Participants Based on CD-related Emergency Room (ER) Visits, Hospitalizations, or Surgeries
timeFrame: Baseline up to Month 12
measure: Number of Participants that initiated Vedolizumab treatment and are still on Vedolizumab treatment at 12 months of follow-up
timeFrame: Baseline up to Month 12
measure: Number of Participants With Reasons for Discontinuation of Vedolizumab Treatment
timeFrame: Baseline up to Month 12
measure: Number of Participants Based on Subsequent Biologic Therapy Type
timeFrame: Baseline up to Month 12
measure: Number of Participants that Received vedolizumab Dose Optimization
timeFrame: Baseline up to Month 12
measure: Time to vedolizumab Dose Optimization
timeFrame: Baseline up to Month 12
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: Kelowna GI Associates
state: British Columbia
city: New Westminster
country: Canada
facility: Fraser Clinical Trials Inc.
state: British Columbia
city: Winnipeg
country: Canada
facility: The Winnipeg Clinic
state: Manitoba
city: Fredericton
country: Canada
facility: REGIONAL HEALTH AUTHORITY B doing business as HORIZON HEALTH NETWORK
state: New Brunswick
city: Halifax
country: Canada
facility: Nova ScotiaHealth Authority
state: Nova Scotia
city: Barrie
country: Canada
facility: Barrie GI Associates
state: Ontario
city: London
country: Canada
facility: Lawson Health Research Institute a joint venture of London Health Science Centre Research Inc., Lawson Research Institute.
state: Ontario
city: Oakville
country: Canada
facility: Girish Bajaj MPC
state: Ontario
city: Toronto
country: Canada
facility: Sinai Health System
state: Ontario
city: Toronto
country: Canada
facility: Kensington Cancer Screening Clinic
state: Ontario
city: Toronto
country: Canada
facility: Toronto Immune and Digestive Health Institute
state: Ontario
city: Montreal
country: Canada
facility: Research Institute McGill University Health Centre (RI-MUHC)
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre integre universitaire de sante et de services sociaux de l'Estrie Centre hospitalier universitaire de Sherbrooke
state: Quebec
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: