IRB Number:

08-005559

Trial status:

Open for Enrollment

Phase: III

Why is this study being done?

The main purpose of this study is to find out whether treatment with Vedolizumab is effective and safe in treating your CD.

Who is eligible to participate?

Patients with active Crohn?s disease.

What is involved?

Induction Phase:
370 subjects will be assigned to Cohort 1. Subjects in this group will receive either Vedolizumab or placebo (inactive salt water). If you are assigned to Cohort 1, you will have a 6 in 10 chance of receiving Vedolizumab.
Approximately 689 subjects will be assigned to Cohort 2. All subjects in Cohort 2 will receive Vedolizumab. Your enrollment into Cohort 1 or 2 will be determined by the timing of your enrollment and your previous exposure to drugs called TNFa antagonists.
Maintenance Phase:
The Induction Phase ends at Week 6. All subjects will then start the Maintenance Phase which lasts 46 weeks. The study drug that you will receive in the Maintenance Phase is based on what you received in the Induction Phase and if you got better.

How long is the study?

You will be in the study for 15 months. You may also be contacted by phone for 2 years after your final dose of study drug.

Ad IRB approved 11/6/09.

Who can I contact for additional information?

Margo Marzolf 507-284-5908

Where is the trial located?

• Rochester, MN

Last updated: 12/01/2009