NCT04362735

Efficacy of Vedolizumab in Crohn's Disease Patients Naive to Biological Therapy

Status unknown Last updated 27 April 2020

What this trial tests

trial testing Vedolizumab in Crohn Disease in 100 participants. Status unknown.

Timeline

1 August 2020

Primary endpoint
20 January 2021

1 April 2021

Quick facts

Lead sponsor	Pontifícia Universidade Católica do Paraná
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	100
Start date	1 August 2020
Primary completion	20 January 2021
Estimated completion	1 April 2021

Drugs / interventions tested

• Vedolizumab (vedolizumab) — full drug profile →

Conditions studied

• Crohn Disease — all drugs for Crohn Disease →

Sponsor

Pontifícia Universidade Católica do Paraná

Who can join

18 and older, any sex, with Crohn Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 endothelium consequently reducing intestinal tissue inflammation. There is scarce evidence on the use of vedolizumab in CD in Brazil, mostly in patients with no previous biological therapy, where the drug seems to have a more adequate therapeutic potential.

Tha primary aim of the study is to analyze clinical remission rates at weeks 12, 26 and 52, and at last follow-up on naive CD patients submitted to vedolizumab therapy. Secondary outcomes will be clinical response rates at weeks 12, 26 and 52, and at last follow-up; endoscopic remission rates in colonoscopies performed; persistence of drug therapy over time; adverse events during treatment with vedolizumab and rates of abdominal surgery during therapy.

METHODS: A retrospective, longitudinal, observational study will be performed with patients with CD who used Vedolizumab at any time of their treatment as the first biologic option, after failure of conventional therapy. Following the induction dose of 300 mg at weeks 0, 2 and 6, and maintenance of 300 mg every 8 weeks, patients will be followed up to 52 weeks (1 year) or more (last follow-up captured). Records of the clinical evaluations at week 12, 26 and 52, and last follow-up, will be checked according to the HBI and PGA to define clinical response or clinical remission. Colonoscopies will also be checked to evaluate mucosal healing. Electronic charts will be reviewed also to analyze adverse events and surgery during therapy.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Vedolizumab in Mild-to-Moderate Crohn's Disease Patients Naïve to Biological Therapy: A Multicentric Observational Study.
   Dotti AZ, Magro DO, Vilela EG, Chebli JMF, et al · · 2023 · cited 4× · PMID 37859629 · DOI 10.1093/crocol/otad053