Corticosteroids With Vedolizumab in Crohn's Disease

Phase 4

Terminated

• Conditions: Crohn's Disease
• Interventions: Drug: Prednisone; Drug: Placebo; Drug: Vedolizumab

• Registration Number: NCT02324699
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Study Timeline

• Study First Submitted: 2014-12-19
• Study First Submitted QC: 2014-12-19
• Study First Posted: 2014-12-24
• Study Start: 2016-04
• Primary Completion: 2018-02-08
• Study Completion: 2018-02-08
• Status Verified: 2019-04
• Results First Submitted: 2019-04-04
• Results First Submitted QC: 2019-04-04
• Last Update Submitted: 2019-04-04
• Results First Posted: 2019-04-26
• Last Update Posted: 2019-04-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prednisone co-inductive therapy	Prednisone	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
Prednisone co-inductive therapy	Vedolizumab	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
Placebo	Placebo	Identical placebo taper
Placebo	Vedolizumab	Identical placebo taper

Primary Outcome Measures

Name	Time	Method
Crohn's Disease Activity Index (CDAI)	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States