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Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's Disease

NCT02630966 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2019-11-19

Study results available
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Summary

The purpose of this study is to evaluate the percentage of participants with perianal fistula healing at Week 30 in 2 different dose regimens of vedolizumab intravenous (IV) 300 milligram (mg) in participants with fistulizing Crohn's disease (CD).

Conditions

Interventions

DRUG

Vedolizumab

Vedolizumab 300 mg IV infusion

DRUG

Placebo

0.9% sodium chloride IV infusion

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-10
Primary Completion
2018-09-04
Completion
2018-11-14

Countries

  • United States
  • Canada
  • France
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02630966 on ClinicalTrials.gov