This study is for patients with moderately to severely active Crohn’s Disease and have failed or your disease is not responding well enough to medicines that decrease the immune-response, specifically oral steroids (for example, prednisone) or methotrexate, or 6-mercaptopurine, or azathioprine.

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

The purpose of this study is to determine whether or not treatment with ustekinumab improves symptoms of Crohn’s disease and also to look for any possible side effects (good and/or bad) in patients with this disease.

Who is eligible to participate?

The target population consists of men or women ≥ 18 years of age with moderately to severely active Crohn’s disease (of at least 3 months duration). Subjects must also have
demonstrated an inadequate response to or have failed to tolerate corticosteroids or immunomodulators: 6-mercaptopurine (6-MP), azathioprine (AZA), and methotrexate (MTX). Subjects having demonstrated corticosteroid dependence (ie, an inability to successfully taper corticosteroids without a return of the symptoms of Crohn’s disease) are eligible for entry into the study.

What is involved?

If you are eligible for the study, we will assign you by chance (like a coin toss) to one of three treatment groups. You may get either ustekinumab or placebo (placebo looks exactly like the study drug, but it contains no active ingredient). The chance that you will get ustekinumab in this study is 2 out of 3.

How long is the study?

Your participation in this study will last for 9 to 13 weeks (depending on how long you are in the screening period). You will visit your study doctor 5 times in this study. At the final visit (which occurs 8 weeks after your infusion), you will be asked to participate in an additional 44-week (maintenance) study and a long-term extension study that will last approximately 4 years. If you become ineligible or choose not to participate in the
maintenance study, your participation in this study will be extended for an additional 12 weeks to look for any potential adverse reactions in a final safety visit.

IRB Number:

13-003319