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Corticosteroids With Vedolizumab in Crohn's Disease

NCT02324699 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2019-04-26

Study results available
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Summary

Use of co-induction with corticosteroid therapies may accelerate the remission rate when used with vedolizumab. Further, this may lead to higher rates of response and remission at week 10 than would be seen with vedolizumab monotherapy.

Conditions

Interventions

DRUG

Prednisone

DRUG

Placebo

DRUG

Vedolizumab

300mg IV over 30 minutes. Both arms will receive vedolizumab at weeks 0, 2, and 6.

Sponsors & Collaborators

Principal Investigators

  • Bruce E Sands, MD, MS · Icahn School of Medicine at Mount Sinai Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2018-02-08
Completion
2018-02-08

Countries

  • United States

Study Locations

More Related Trials

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 NCT02324699 on ClinicalTrials.gov