Corticosteroids With Vedolizumab in Crohn's Disease

Mount Sinai Health System

Status and phase: Terminated; Phase 4

Conditions: Crohn's Disease

Treatments: Drug: Prednisone; Drug: Vedolizumab; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02324699

GCO 14-2209

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1 participants in 2 patient groups, including a placebo group

Prednisone co-inductive therapy

Experimental group

Description:

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

Treatment:

Drug: Vedolizumab

Drug: Prednisone

Placebo

Placebo Comparator group

Description:

Identical placebo taper

Treatment:

Drug: Placebo

Drug: Vedolizumab