Efficacy and Safety of Ustekinumab in Crohn's Disease

• Research type

  Research Study

• Full title

  A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Ustekinumab Therapy in Subjects with Moderately to Severely Active Crohn's Disease Previously Treated with TNF Antagonist Therapy

• IRAS ID

  5706

• Contact name

  Chris Probert

• Sponsor organisation

  Centocor B.V

• Eudract number

  2008-000649-77

• ISRCTN Number

  N/A

• Research summary

  In Crohns disease there is inflammation (changes in body tissue which normally happen during injury or infection) and or ulceration (open sores) in the intestines. This occurs because the immune system has an abnormal and overactive response against the intestine and bowel tissues of the body. Crohns disease is usually treated with medications that either directly decrease inflammation or decrease the general activity of the immune system to improve the diarrhea, abdominal pain, and other symptoms. Ustekinumab antibodies (natural substances made by your immune system to stick to and help remove foreign materials in your body that cause diseases) have been created to stick to and block the activity of two of the immune substances thought to cause abnormal inflammation of Crohns disease. Patients who are eligible and who have received Remicade, Humira, or Cimzia and failed or been intolerant to one of these drugs will be randomized to either active drug (ustekinumab) or placebo. All patients will be randomized (like flipping a coin) at week 0 to be in one of 4 groups. At week 0 the study drug will be given by IV administration and at weeks 8 and 16 by subcutaneous injection. There will be 11 study visits in total and the study will continue until week 36. Blood and stool samples will be collected and studied, questionnaires to check on how you are doing in terms of your disease will be completed, an Electrocardiogram (EKG) obtained, safety evaluations conducted and diary cards distributed to be completed during the entire study. One of 4 groups: Grp 1-placebo, Grp 2-active drug 1mg/kg IV, Grp 3-active drug 3mg/kg IV, Grp 4-active drug 6mg/kg IV. Based on the clinical response status at Week 6, patients from Grps 2, 3 and 4 will be re-randomized at week 8 to receive either placebo or 90 mg SC at both weeks 8 and 16 and patients from Grp 1 will receive placebo at Week 8 and Week 16 or a 270 mg SC injection at Week 8 and 90 mg SC at Week 16.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  08/H0604/165

• Date of REC Opinion

  23 Jan 2009

• REC opinion

  Further Information Favourable Opinion