IMUNITI

• 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 Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease

• IRAS ID

  82940

• Contact name

  Stuart Bloom

• Sponsor organisation

  Janssen-Cilag International N.V.

• Eudract number

  2010-022760-12

• Clinicaltrials.gov Identifier

  NCT01369355

• Research summary

  The main purpose of this study is to determine whether additional ustekinumab treatment is beneficial in patients with moderately to severely active Crohn??s disease who initially had a clinical response to ustekinumab in the initial induction studies (CNTO1275CRD3001 [??UNITI-1?] or CNTO1275CRD3002 [??UNITI-2?]). Participants in response to ustekinumab will be randomised (by chance, like rolling dice) to receive either placebo (Group 1), 90 mg Ustekinumab every 12 weeks (Group 2), or 90 mg Ustekinumab every 8 weeks (Group 3). If participants lose response, they will then receive 90mg ustekinumab every 8 weeks. Other populations (non-responders to prior ustekinumab or placebo) will receive ustekinumab at week 0 (either 90 mg or 130 mg, respectively) and continue ustekinumab if in response at Week 8. Participants in clinical response to placebo will continue to receive placebo at week 0 and every 4 weeks thereafter. The study will be double-blinded (so that neither participants nor study personnel know the the assigned treatment). All participants from the UNITI-1 or UNITI-2 studies will be eligible to enter this study, provided the Week 8 visit in those trials was completed and study requirements are still met. The main part of this study, also called the maintenance portion, will last 44 weeks. After week 44, all participants who are continuing to do well will be eligible to continue to receive study agent in the second part of the study, a long term extension where the study agent will continue to be administered for (up to) 3 additional years. Participants who discontinue study agent, either during the study, or after the full 4 years, will be asked to return for a final safety follow-up visit 20 weeks after they last received study agent.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  11/SC/0329

• Date of REC Opinion

  21 Oct 2011

• REC opinion

  Further Information Favourable Opinion