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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT04362735
Date of registration: 19/04/2020
Prospective Registration: Yes
Primary sponsor: Pontifícia Universidade Católica do Paraná
Public title: Efficacy of Vedolizumab in Crohn's Disease Patients Naive to Biological Therapy
Scientific title: Efficacy of Vedolizumab in Crohn's Disease Patients Naive to Biological Therapy: a Brazilian Multicentric Observational Real-world Study
Date of first enrolment: August 1, 2020
Target sample size: 100
Recruitment status: Not yet recruiting
URL:  https://clinicaltrials.gov/show/NCT04362735
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Contacts
Name:     Paulo Kotze, phd
Address: 
Telephone: +5541996648989
Email: pgkotze@hotmail.com
Affiliation: 
Name:     Paulo Kotze, phd
Address: 
Telephone:
Email:
Affiliation:  Professor of postgraduate program
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with CD (any location)who used vedolizumab as the first biological agent during
medical treatment, after failure of conventional therapy (5-ASA, steroids and/or
immunomodulators such as azathioprine and methotrexate).

Exclusion Criteria:

- Patients with UC

- Patients with other causes of intestinal inflammation (ischemic or infectious colitis,
for example) non-IBD related

- Patients with IBD-undetermined not defined as CD or UC

- Patients with vedolizumab who had previous exposure to anti-TNF agents

- Pregnant patients

- Pediatric patients (less than 18 years old)



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Crohn Disease
Intervention(s)
Drug: Vedolizumab
Primary Outcome(s)
Clinical remission [Time Frame: 12 weeks]
Clinical remission [Time Frame: 26 weeks]
Clinical remission [Time Frame: 52 weeks]
Secondary Outcome(s)
Clinical response [Time Frame: 12 weeks]
Clinical response [Time Frame: 26 weeks]
Clinical response [Time Frame: 52 weeks]
Mucosal healing [Time Frame: through study completion, an average of 52 weeks]
Need for major surgery during treatment [Time Frame: through study completion, an average of 52 weeks]
Secondary ID(s)
IISR-2020-103104
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Takeda
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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