Corticosteroids With Vedolizumab in Crohn's Disease

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02324699
• Other study ID #: GCO 14-2209
• Status: Terminated
• Phase: Phase 4
• Start date: April 2016
• Est. completion date: February 8, 2018

Study information

• Verified date: April 2019
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: February 8, 2018
• Est. primary completion date: February 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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-TNFa 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-TNFa 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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Prednisone

• Placebo

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

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	baseline and week 10
Secondary	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.	baseline and week 10
Secondary	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.	baseline, week 6 and week 10