UNITI 1
Research type
Research Study
Full title
A Phase 3, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Participants with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy
IRAS ID
80224
Contact name
Stuart Bloom
Sponsor organisation
Janssen-Cilag International N.V.
Eudract number
2010-022758-18
Clinicaltrials.gov Identifier
Research summary
This study (CNTO1275CRD3001 or ??UNITI-1?Â) examines ustekinumab (an antibody medication that inhibits the inflammatory proteins IL-12 and IL-23) versus a placebo (otherwise identical except without the ustekinumab antibody) given intravenously in adults with moderately to severely active Crohn??s disease who previously did not respond to, lost response to, or could not tolerate TNF-antagonist medications (specifically, infliximab, adalimumab or certolizumab pegol). Ustekinumab (also known as Stelara) is approved as a treatment for the skin condition of moderate to severe plaque-type psoriasis, but this study will examine if ustekinumab can provide benefit in Crohn??s disease and also assess for any risks or side effects. Both the positive and negative outcomes of IV placebo versus two different doses of IV ustekinumab will be tracked and compared over eight weeks in approximately 675 participants. Participants enrolling in this study will be assigned to one of the 3 treatment groups by chance (randomly, like rolling dice), and all will receive a single IV administration of study agent at the first study visit (after the screening period), and then will be asked to return for 3 additional visits through Week 8. The study is blinded so neither the participant nor the doctor will know which treatment has been assigned throughout the study. Participants who complete this study through the Week 8 visit and remain eligible can enter the maintenance study (CNTO1275CRD3003 or ??IM-UNITI?Â), where they will receive additional study agent, including the administration of ustekinumab in participants who receive placebo in this study and have not had improvement in their Crohn??s disease. Patients who do not enter the CNTO1275CRD3003 study will have a final safety follow-up visit approximately 20 weeks after they received study agent when they entered into this study at the Week 0 visit.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
11/SC/0326
Date of REC Opinion
21 Oct 2011
REC opinion
Further Information Favourable Opinion