Diagnosis: Moderate to Severe, Active Crohn’s Disease
Study Name and Description:
A Trial to Evaluate the Effectiveness and Safety of Ustekinumab Therapy for Patients with Moderate to Severe, Active Crohn’s Disease
Ustekinumab is an antibody being used as a possible treatment for Crohn’s disease. Antibodies are natural substances made by your immune system to stick to and help remove foreign material in your body that cause diseases. Although Antibodies are normally important in helping fight infections, in this case the ustekinumab antibodies have been created to block immune substances thought to cause the abnormal inflammation of Crohn’s disease.
This research study is evaluating the effectiveness and safety of a new drug for Crohn’s disease called Ustekinumab. This therapy is reserved for patients not responding to conventional medications to Crohn’s disease. If you choose to participate in this study you will be randomized to one of four groups testing different doses of Ustekinumab vs. placebo ( an inactive substance.) The first dose of is administered through infusion and the subsequent doses are given through sub-cutaneous injection (a shot.) The study drug (or placebo) is administered a total of three times.
This clinical trial consists of 11 visits over a 9 month period.
You will not be paid for participation in this study, but all related study medications, office visits, and parking will be at no cost to you.
Contact: For more information, interested participants and clinicians may contact Michael Uetrecht at 847.570.1762 or e-mail muetrecht@northshore.org
Diagnosis: Mild to Moderate Ulcerative Colitis
Study Name and Description:
A Trial to Test the Effectiveness and Safety of Budesonide-MMX in Patients with Mild to Moderate Ulcerative Colitis
Budesonide-MMX is a new drug being tested for Ulcerative Colitis. MMX is a new controlled release system in extended-release tablets that releases the active ingredient in the distal gastro-intestinal tract at a controlled rate.
This research study is testing the effectiveness and safety of a drug for Ulcerative Colitis called Budesonide-MMX, which is an investigational formulation that is not approved by the FDA. The drug Budesonide is approved by the FDA, and is often used in the care of patients with Crohn’s disease and ulcerative colitis. This investigational medication differs in the delivery mechanism, which spreads throughout the whole colon.
A colonoscopy is performed to examine the colon.
This clinical trial consists of 6 visits over a two month period.
You will not be paid for participation in this study, but all related study medications, office visits, and parking will be at no cost to you.
Contact: For more information, interested participants and clinicians may contact Michael Uetrecht at 847.570.1762 or e-mail muetrecht@northshore.org