Corticosteroids With Vedolizumab in Crohn's Disease

April 4, 2019 updated by: Bruce E. Sands, Icahn School of Medicine at Mount Sinai

Corticosteroids as Co-Induction Agents With Vedolizumab in Crohn's Disease: a Double-blind Placebo Controlled Randomized Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This study will examine prednisone co-induction with vedolizumab in patients with Crohn's disease. To address questions regarding the effect of co-induction on mucosal healing, the study will include colonoscopic assessment of mucosal healing. Finally, colonic biopsies in this study will allow to elucidate further the mechanism of action of vedolizumab in Crohn's disease through immune phenotyping studies.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age at entry 18 to 70
  • CDAI score > 220
  • Concomitant azathioprine, methotrexate, or mercaptopurine permitted if dose has been stable for > 8 weeks. Prior anti-TNFα antibody use permitted but must be discontinued (>2 weeks from last dose) prior to initiation of vedolizumab.
  • Documented ulceration on colonoscopy done at screening of 3 or more large ulcers or 10 or more aphthous ulcers
  • Able to provide written informed consent.
  • Patient is planned for or eligible to initiate vedolizumab

Exclusion Criteria:

  • Concurrent use of anti-TNFα antibodies.
  • No corticosteroids within prior 3 months (other than budesonide controlled ileal release)
  • No stoma at the time of enrollment
  • No absolute contraindication to systemic corticosteroid use such as hypersensitivity to any part of the formulation, systemic fungal infection, or recent administration of live or live attenuated vaccine within prior two weeks.
  • Pregnant women or plans for pregnancy within 3 months of study inclusion
  • Presence of stoma, more than three small-bowel resections, or documented history of short bowel syndrome
  • Intestinal stricture requiring surgery
  • Abdominal abscess
  • Inability or unwillingness to provide informed consent
  • Any other condition, which, in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prednisone co-inductive therapy
Prednisone 40 mg/day starting at week 0 for 2 weeks, tapered by 10 mg weekly to achieve 0 mg by end of week 5
Drug: Prednisone
Other Names:
  • corticosteroids
Drug: Vedolizumab
300mg IV over 30 minutes. Both arms will receive vedolizumab at weeks 0, 2, and 6.
Other Names:
  • Entyvio
Placebo Comparator: Placebo
Identical placebo taper
Drug: Placebo
Drug: Vedolizumab
300mg IV over 30 minutes. Both arms will receive vedolizumab at weeks 0, 2, and 6.
Other Names:
  • Entyvio

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Crohn's Disease Activity Index (CDAI)
Time Frame: baseline, week 6, week 10
Clinical remission, defined as CDAI < 150, in group with steroid co-induction vs. placebo co-induction. The purpose of this crohn's disease activity index (CDAI) calculator is to gauge the progress or lack of progress for people with crohn's disease. CDAI scores below 150 indicate a better prognosis than higher scores
baseline, week 6, week 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Simple Endoscopic Score for Crohn's Disease (SES-CD)
Time Frame: baseline and week 10
The SES-CD tool is used to quantify and compare inflammatory load. The Simple Endoscopic Score for Crohn Disease (SES-CD) assesses the size of mucosal ulcers, the ulcerated surface, the endoscopic extension and the presence of stenosis. Each item is scored from 0-3, with total score from 0-60. Higher score indicates more severe endoscopic activity.
baseline and week 10
Change in C-Reactive Protein (CRP)
Time Frame: baseline and week 10
Comparison of absolute change in CRP from baseline to week 10. C-reactive protein is produced by the liver. The level of CRP rises when there is inflammation throughout the body.
baseline and week 10
Change in Calprotectin
Time Frame: baseline, week 6 and week 10
Comparison of absolute change in calprotectin from baseline to week 6. Calprotectin is a stool (fecal) test that is used to detect inflammation in the intestines.
baseline, week 6 and week 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

Takeda

Investigators

  • Principal Investigator: Bruce E Sands, MD, MS, Icahn School of Medicine at Mount Sinai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

February 8, 2018

Study Completion (Actual)

February 8, 2018

Study Registration Dates

First Submitted

December 19, 2014

First Submitted That Met QC Criteria

December 19, 2014

First Posted (Estimate)

December 24, 2014

Study Record Updates

Last Update Posted (Actual)

April 26, 2019

Last Update Submitted That Met QC Criteria

April 4, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 14-2209

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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