ENTYVIO in Bio-naive Patients With Moderate/Severe Crohn's Disease (CD) in Daily Practice
NCT ID: NCT04349449
Last Updated: 2020-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2020-09-30
2022-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
2. Has isolated and active perianal disease in the absence of luminal CD.
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Kelowna GI Associates
Kelowna, British Columbia, Canada
Fraser Clinical Trials Inc.
New Westminster, British Columbia, Canada
The Winnipeg Clinic
Winnipeg, Manitoba, Canada
REGIONAL HEALTH AUTHORITY B doing business as HORIZON HEALTH NETWORK
Fredericton, New Brunswick, Canada
Nova ScotiaHealth Authority
Halifax, Nova Scotia, Canada
Barrie GI Associates
Barrie, Ontario, Canada
Lawson Health Research Institute a joint venture of London Health Science Centre Research Inc., Lawson Research Institute.
London, Ontario, Canada
Girish Bajaj MPC
Oakville, Ontario, Canada
Sinai Health System
Toronto, Ontario, Canada
Kensington Cancer Screening Clinic
Toronto, Ontario, Canada
Toronto Immune and Digestive Health Institute
Toronto, Ontario, Canada
Research Institute McGill University Health Centre (RI-MUHC)
Montreal, Quebec, Canada
Centre integre universitaire de sante et de services sociaux de l'Estrie Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
University of Saskatchewan
Saskatoon, Saskatchewan, Canada
Countries
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Other Identifiers
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U1111-1217-6862
Identifier Type: REGISTRY
Identifier Source: secondary_id
MACS-2017-102118
Identifier Type: OTHER
Identifier Source: secondary_id
Vedolizumab-4022
Identifier Type: -
Identifier Source: org_study_id
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