Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study was to determine the effect of vedolizumab induction treatment on clinical response and remission at 6 weeks and to determine the effect of vedolizumab maintenance treatment on clinical remission at 52 weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Millennium Pharmaceuticals, Inc.
• Treatments: Vedolizumab

Criteria

Inclusion Criteria:

1. Age 18 to 80

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

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 1 of the following agents, within protocol-specified parameters:

1. Immunomodulators

2. Tumor necrosis factor-alpha (TNFα) antagonists

3. Corticosteroids

5. May be receiving a therapeutic dose of conventional therapies for irritable bowel disease (IBD) defined by the protocol

Exclusion Criteria

1. Evidence of abdominal abscess at the initial screening visit, other than a minimum of 10 aphthous ulcerations involving a minimum of 10 contiguous cm of intestine

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