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A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn's Disease

Phase 3
18 Years
80 Years
Not Enrolling
Crohn's Disease

Thank you

Trial Information

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by 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

- May be receiving a therapeutic dose of conventional therapies for 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; HIV infection

- Active or latent tuberculosis

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Proportion of patients in clinical remission in the tumor necrosis factor alpha antagonist therapy subpopulation

Outcome Time Frame:

Week 6

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

November 2010

Completion Date:

April 2012

Related Keywords:

  • Crohn's Disease
  • Crohn Disease



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