Corticosteroids With Vedolizumab in Crohn's Disease

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.

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