Characterization of CD Responders to Vedolizumab

Inclusion criteria

• Male or Female ≥18 and ≤70 years old.
• Patients must be appropriate for baseline colonoscopy prior to induction therapy with vedolizumab.
• Patients must have active inflammatory disease as seen by colonoscopy. 3A-Adult patients with moderately to severely active UC who have:

• had an inadequate response with, lost response to, or were;
• intolerant to a tumor necrosis factor (TNF) blocker or;
• immunomodulator; or had an inadequate response with, were;
• intolerant to, or demonstrated dependence on corticosteroids:

• inducing and maintaining clinical response
• inducing and maintaining clinical remission
• improving endoscopic appearance of the mucosa
• achieving corticosteroid-free remission 3B-Adult patients with moderately to severely active CD who have

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• had an inadequate response with, lost response to, or were
• intolerant to a TNF blocker or immunomodulator; or had an
• inadequate response with, were intolerant to, or demonstrated
• dependence on corticosteroids:

• achieving clinical response
• achieving clinical remission
• achieving corticosteroid-free remission
• Patients will also have biochemical analysis with CRP and fecal calprotectin prior to initiating treatment with vedolizumab.

Exclusion criteria

• Patients that will not undergo colonoscopy at baseline prior to treatment with vedolizumab.
• Patients who do not have endoscopic or biochemical (CRP, calprotectin) evidence of inflammation.
• Patients that have been on natalizumab within 12 weeks of beginning vedolizumab.
• Previous treatment with cyclosporine, thalidomide, or investigational drugs within 30 days of enrollment, prior treatment with vedolizumab
• Toxic megacolon
• Abdominal abscess
• Symptomatic colonic stricture
• Stoma
• Increased risk of infection (eg, active or latent tuberculosis, immunodeficiency) Other clinically meaningful laboratory abnormalities: pregnancy or lactation, an unstable or uncontrolled medical disorder, colonic dysplasia or adenomas, and malignant neoplasms.