IRB Number:

07-003521

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

The main purpose of this study is to assess the effects (good and bad) of golimumab on subjects with ulcerative colitis.

Who is Eligible to Participate in the Study?

Patients with ulcerative colitis

Minimum Age:

18

Maximum Age:

101

What is Involved With this Study?

There are two parts to this study. Part 1 is called "dose-ranging." This means that different doses of medication are being tested to find out which dose(s) will be used for further testing in the treatment of ulcerative colitis. Part 2 is called "dose confirming." This means that the selected dose(s) from Part 1 will be further tested in the treatment of ulcerative colitis. If you are among the first 176 subjects to enroll, you will be enrolled in Part 1. If you enroll in Part 1, you will be randomized to one of four treatment groups and will receive subcutaneous injections at Week 0 and Week 2.

How long will the Study run?

Up to 20 weeks

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: 10/24/2008