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 (CERTIFI)
Summary:
| HR#: |
18962 |
| PRINCIPAL INVESTIGATOR: |
Todd Dantzler, , MD |
| SPONSOR: |
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| TARGET ENROLLMENT: |
10 |
| DISEASE TYPE: |
Crohns Disease |
| BODY LOCATION(S): |
Large Intestine,Other, |
| PRIMARY OBJECTIVE: |
Centocor, Inc. (the sponsor of the study) is conducting a medical research study designed to investigate the safety and the effectiveness of an experimental drug called ustekinumab in adult patients who have moderate to severe Crohn’s disease. |
| SECONDARY OBJECTIVE(S): |
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| INCLUSION CRITERIA: |
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| EXCLUSION CRITERIA: |
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| TREATMENT GROUPS: |
All subjects will be randomized to receive 1 of 4 induction regimens, then will be re-randomized at Week 8 (with two separate randomizations, one for subjects in clinical response at Week 6 and one for those not in clinical response at Week 6) to receive 1 of 2 treatment regimens. |
| LENGTH OF STUDY: |
36 Weeks |
| CONTACTS: |
- , (Primary Study Coordinator)
or
- Kyle Orrell, MSHP (DDC Research Program Manager)
843-876-4303 or orrell@musc.edu
- Todd Dantzler, , MD (Principal Investigator)
(843) 876-4261 or dantzlet@musc.edu
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