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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