NCT02324699

Corticosteroids With Vedolizumab in Crohn's Disease

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Prednisone
DRUG	Placebo
DRUG	Vedolizumab	300mg IV over 30 minutes. Both arms will receive vedolizumab at weeks 0, 2, and 6.

Timeline

• Start date: 2016-04-01
• Primary completion: 2018-02-08
• Completion: 2018-02-08
• First posted: 2014-12-24
• Last updated: 2019-04-26
• Results posted: 2019-04-26

Locations

1 site across 1 country: United States