Status:
UNKNOWN
Efficacy of Vedolizumab in Crohn's Disease Patients Naive to Biological Therapy
Lead Sponsor:
Pontifícia Universidade Católica do Paraná
Collaborating Sponsors:
Takeda
Conditions:
Crohn Disease
Eligibility:
All Genders
18+ years
Brief Summary
INTRODUCTION: Vedolizumab is a gut selective anti-integrin agent which binds to the alfa4beta7 integrin, preventing its coupling to the endothelial MadCAM-1. It reduces leucocyte trafficking from the ...
Detailed Description
INTRODUCTION: Inflammatory bowel diseases (IBD) are a group of chronic, idiopathic and immune-mediated diseases, mainly represented by Crohn's disease (CD) and Ulcerative Colitis (UC). There is a broa...
Eligibility Criteria
Inclusion
- \- 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
- 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)
Key Trial Info
Start Date :
August 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04362735
Start Date
August 1 2020
End Date
April 1 2021
Last Update
April 27 2020
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