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Category: Gastroenterology/Hepatology,
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HIC#14449
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| 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 |
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Contact:Sandra Oliphant
Phone:(434)982-0871
E-mail:slo2n@virginia.edu
The UVA Digestive Health Center of Excellence is seeking men and women age 18 and older with active Crohn's disease to participate in a clinical trial using the experimental medication ustekinumab. Ustekinumab is an antibody that helps to block two of the immune substances (Interleukin-12 and Interleukin-23) that are thought to cause the abnormal inflammation of Crohn's disease. The purpose of this study is to compare the effects, good and/or bad, of ustekinumab with that of a placebo in inducing a clinical response in participants with moderate to severe Crohn's disease who have failed or are intolerant to TNF antagonist therapy (ie: infliximab, adalimumab, & certolizumab pegol).
Participants that enroll in the study will take ustekinumab or a placebo intravenous for the first of the three treatments at week 0. The remaining 2 treatments will be given as three subcutaneous injections during week 8 and 16.
All participants will be randomized to receive one of the following treatment groups at Week 0; you have a 75% chance of receiving ustekinumab at a varied dose:
Group 1 placebo IV at Week 0
Group 2 ustekinumab 1 mg/kg IV at Week 0
Group 3 ustekinumab 3 mg/kg IV at Week 0
Group 4 ustekinumab 6 mg/kg IV at Week 0
At Week 6, all participants will be re-randomized based on what group they were assigned for Week 0 and also what their response to that treatment was. Participants will be re-randomized to receive 1 of the 3 following treatment regimens:
placebo SC injections at Weeks 8 and 16
ustekinumab 90 mg SC injections at Weeks 8 and 16
ustekinumab 270mg SC injection at Week 8 &
ustekinumab 90mg SC injection at Week 16
Eligible participants will have all study-related care and the study medication provided free of charge; please note you will receive compensation for time or travel for each visit The study duration will be 36 weeks.
Contact: Sandra Oliphant, RN (434) 982 - 0871
HIC 14449
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 Primary Investigator: Behm Brian,
Department: Internal Medicine
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Accepts adult enrollment :YES
Accepts minor enrollment :NO |