IRB Number:

08-004353

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

The purpose of this study is to determine the effects (good and bad) of an investigational drug called ustekinumab in patients with Crohn's disease.

Who is Eligible to Participate in the Study?

Patients with active Crohn's Disease

Minimum Age:

18

Maximum Age:

101

What is Involved With this Study?

You will be put in 1 of 4 groups by chance (as in the flip of a coin). The chance that you will get ustekinumab is 3 out of 4.
- Group 1: placebo IV
- Group 2: 1 mg/kg IV ustekinumab
- Group 3: 3 mg/kg IV ustekinumab
- Group 4: 6 mg/kg IV ustekinumab

How long will the Study run?

You will be in the study for about 36 weeks (about 9 months). Planned follow-up visits will last up to 20 weeks after you receive your last study treatment.

Who can I Contact for Additional Information on this Trial?

Margo Marzolf at 507-284-5908.

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 03/16/2009