Corticosteroids With Vedolizumab in Crohn's Disease

NCT02324699 | Terminated Phase 4 Results DMC

• 1 other identifier: GCO 14-2209
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn's Disease

Keywords

Vedolizumab; Corticosteroids; Prednisone; Crohn's disease

Outcome Measures

Primary Outcomes (1)

• 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

  baseline, week 6, week 10

Secondary Outcomes (3)

• Change in Simple Endoscopic Score for Crohn's Disease (SES-CD)

  baseline and week 10

• Change in C-Reactive Protein (CRP)

  baseline and week 10

• Change in Calprotectin

  baseline, week 6 and week 10

Study Arms (2)

Prednisone co-inductive therapy

EXPERIMENTAL

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; Drug: Vedolizumab

Placebo

PLACEBO COMPARATOR

Identical placebo taper

Drug: Placebo; Drug: Vedolizumab

Interventions

Prednisone DRUG

Also known as: corticosteroids

Prednisone co-inductive therapy

Placebo DRUG

Placebo

Vedolizumab DRUG

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

Also known as: Entyvio

Placebo; Prednisone co-inductive therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Takeda: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Prednisone; Adrenal Cortex Hormones; vedolizumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Limitations and Caveats

Study terminated due to enrollment difficulty.

Results Point of Contact

• Title: Dr. Bruce Sands
• Organization: Icahn School of Medicine at Mount Sinai

bruce.sands@mssm.edu

212-241-8100

Study Officials

• Bruce E Sands, MD, MS

  Icahn School of Medicine at Mount Sinai Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine Division of Gastroenterology

Study Record Dates

• First Submitted: December 19, 2014
• First Posted: December 24, 2014
• Study Start: April 1, 2016
• Primary Completion: February 8, 2018
• Study Completion: February 8, 2018
• Last Updated: April 26, 2019
• Results First Posted: April 26, 2019

Record last verified: 2019-04

Locations

US (1)