search
Back to results

Corticosteroids With Vedolizumab in Crohn's Disease

Primary Purpose

Crohn's Disease

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Prednisone
Placebo
Vedolizumab
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Vedolizumab, Corticosteroids, Prednisone, Crohn's disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Prednisone co-inductive therapy

Placebo

Arm Description

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

Identical placebo taper

Outcomes

Primary Outcome Measures

Crohn's Disease Activity Index (CDAI)
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

Secondary Outcome Measures

Change in Simple Endoscopic Score for Crohn's Disease (SES-CD)
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.
Change in C-Reactive Protein (CRP)
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.
Change in Calprotectin
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.

Full Information

First Posted
December 19, 2014
Last Updated
April 4, 2019
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Takeda
search

1. Study Identification

Unique Protocol Identification Number
NCT02324699
Brief Title
Corticosteroids With Vedolizumab in Crohn's Disease
Official Title
Corticosteroids as Co-Induction Agents With Vedolizumab in Crohn's Disease: a Double-blind Placebo Controlled Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Difficult recruitment
Study Start Date
April 2016 (undefined)
Primary Completion Date
February 8, 2018 (Actual)
Study Completion Date
February 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Takeda

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Vedolizumab, Corticosteroids, Prednisone, Crohn's disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prednisone co-inductive therapy
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Identical placebo taper
Intervention Type
Drug
Intervention Name(s)
Prednisone
Other Intervention Name(s)
corticosteroids
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Vedolizumab
Other Intervention Name(s)
Entyvio
Intervention Description
300mg IV over 30 minutes. Both arms will receive vedolizumab at weeks 0, 2, and 6.
Primary Outcome Measure Information:
Title
Crohn's Disease Activity Index (CDAI)
Description
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
Time Frame
baseline, week 6, week 10
Secondary Outcome Measure Information:
Title
Change in Simple Endoscopic Score for Crohn's Disease (SES-CD)
Description
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.
Time Frame
baseline and week 10
Title
Change in C-Reactive Protein (CRP)
Description
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.
Time Frame
baseline and week 10
Title
Change in Calprotectin
Description
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.
Time Frame
baseline, week 6 and week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce E Sands, MD, MS
Organizational Affiliation
Icahn School of Medicine at Mount Sinai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Corticosteroids With Vedolizumab in Crohn's Disease

We'll reach out to this number within 24 hrs