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A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) 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 and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease

Inclusion Criteria:

1. Age 18 to 80

2. Diagnosis of moderately to severely active Crohn's disease

3. CD involvement of the ileum and/or colon

4. 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

5. May be receiving a therapeutic dose of conventional therapies for IBD as defined by
the protocol

Exclusion Criteria

1. Evidence of abdominal abscess at the initial screening visit

2. Extensive colonic resection, subtotal or total colectomy

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

4. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine

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

6. Chronic hepatitis B or C infection

7. Active or latent tuberculosis

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Proportion of patients in clinical remission

Outcome Time Frame:

Week 6 & 52

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:

December 2008

Completion Date:

May 2012

Related Keywords:

  • Crohn's Disease
  • Crohn Disease



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