Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease

Inclusion Criteria:

• Age 18 to 80

• Diagnosis of moderately to severely active Crohn's disease

• Crohn's Disease involvement of the ileum and/or colon

• Demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance of at least one conventional therapy as defined by the protocol

• May be receiving a therapeutic dose of conventional therapies for inflammatory bowel disease (IBD) as defined by the protocol

Exclusion Criteria

• Evidence of abdominal abscess at the initial screening visit

• Extensive colonic resection, subtotal or total colectomy

• History of >3 small bowel resections or diagnosis of short bowel syndrome

• Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine

• Have received non permitted therapies within either 30 or 60 days, depending on the medication, as stated in the protocol

• Chronic hepatitis B or C infection; human immunodeficiency virus (HIV) infection

• Active or latent tuberculosis