Corticosteroids With Vedolizumab in Crohn's Disease

NCT ID: NCT02324699

Last Updated: 2019-04-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2018-02-08

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.

Conditions

Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Prednisone

Intervention Type: DRUG

Vedolizumab

Intervention Type: DRUG

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

Placebo

Identical placebo taper

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Vedolizumab

Intervention Type: DRUG

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

Interventions

Prednisone

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Vedolizumab

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

Intervention Type: DRUG

Other Intervention Names

corticosteroids; Entyvio

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Bruce E. Sands

Professor of Medicine Division of Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bruce E Sands, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai Hospital

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

GCO 14-2209

Identifier Type: -

Identifier Source: org_study_id