A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI) | Not Recruiting
A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI)

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Crohn's Disease
  • Colitis
  • IBD
  • Inflammatory Bowel Disease
Unfortunately contact details are not available for this trial.
Primary Contact Details
Not Recruiting
Recruitment Status
Primary Trial ID Number
The primary purpose of this study is to evaluate the efficacy and safety of 2 maintenance regimens of ustekinumab administered subcutaneously to patients with moderately to severely active Crohn's disease who responded to treatment with intravenous ustekinumab in studies CNTO1275CRD3001 and CNTO1275CRD3002, compared to subcutaneously administered placebo.
Research Details
  • 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 IV ustekinumab in one of the 2 initial induction studies (the CNTO1275CRD3001 ["UNITI-1"] or CNTO1275CRD3002 ["UNITI-2"] induction studies). The maintenance treatment will be injections in the skin (given subcutaneously, or "SC") of 90 mg ustekinumab either every 8 weeks or 12 weeks, and the effects (both the benefits and any side effects or adverse events) will be compared to SC placebo injections (otherwise identical except without ustekinumab). Patients who responded to IV ustekinumab in the UNITI-1 or UNITI-2 induction studies will be put into one of these 3 groups by chance (randomly, like rolling dice). The study will be double-blinded (so that neither patients nor study personnel know the identity of the assigned treatment). Patients who are randomized to either SC placebo or 90mg ustekinumab SC every 12 weeks who experience worsening in their Crohn's Disease symptoms (per the study loss of response criteria) will have their treatment adjusted so that they will instead start to receive 90mg ustekinumab SC every 8 weeks. All patients from the UNITI-1 or UNITI-2 studies (in addition to the patients described above who responded to IV ustekinumab) will be eligible to enter this study, provided the Week 8 visit in those trials was completed and study requirements are still met. Patients who are not in clinical response to IV placebo or ustekinumab in UNITI-1 or UNITI-2 will receive both IV and SC study agent at the first visit of this study (week 0). Patients previously receiving IV placebo will receive ustekinumab 130 mg IV at week 0 (and SC placebo), and patients previously receiving IV ustekinumab will receive 90 mg ustekinumab SC at week 0 (as well as IV placebo). If these patients are in clinical response 8 weeks later, they will receive 90 SC ustekinumab at that week8 visit, and will continue to receive ustekinumab throughout the rest of the study (provided they otherwise remain eligible). Patients in clinical response to IV placebo induction dosing will continue to receive SC placebo. 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 up to week 252. Participants who discontinue study agent, either during the study, or after week 252, will be asked to return for a final safety follow-up visit 20 weeks after they last received study agent. Patients in response to IV ustekinumab will be randomized to receive either placebo (Group 1), Ustekinumab 90 mg SC every 12 weeks (Group 2), or Ustekinumab 90mgSC every 8 weeks (Group 3). If patients in Groups 1 or 2 lose response, they will cross over to receive ustekinumab 90mg every 8 weeks. Other populations (nonresponders to prior IV ustekinumab or IV placebo) will receive ustekinumab at Week0 (either 90mg SC or 130mg IV, respectively) and continue SC ustekinumab if in response at Week8
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Study Type
Drug : Placebo, Drug : Ustekinumab, Drug : Ustekinumab, Drug : Ustekinumab, Drug : Ustekinumab

Study Arm Groups : 001, 002, 003, 004, 005

Intervention Type
See Interventions above
Primary Outcome Measures
  • Clinical remission; at Week 44
Secondary Outcome Measures
  • Remission in patient subgroups such as those in remission at Week 0 or those who previously failed TNF-antagonists (ie, patients entering from study CNTO1275CRD3001); at Week 44; Clinical response; at Week 44; Corticosteroid-free remission; at Week 44
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Age Range
18 Years - 99 Years
Who Can Participate
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
  • Inclusion Criteria:
  • - Patients who received study agent at the start of study CNTO1275CRD3001 or
  • CNTO1275CRD3002 and completed the Week 8 visit. Exclusion Criteria:
  • - Patients who underwent a Crohn's disease-related surgery since the start of induction
  • study CNTO1275CRD3001 or CNTO1275CRD3002
  • - Patients who started a protocol prohibited medication since the start of studies
  • CNTO1275CRD3001 and CNTO1275CRD3002
  • - Patients with protocol-specified changes to their concomitant medications due to
  • Crohn's disease (due to lack of efficacy) since the start of studies CNTO1275CRD3001
  • and CNTO1275CRD3002
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Bristol Royal Hospital
Southampton General Hospital
Gloucestershire Royal Hospital
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Croatia, Czech Republic, Denmark, France, Germany, Hungary, Iceland, Ireland, Israel, Japan, Korea, Republic of, Netherlands, New Zealand, Poland, Russian Federation, Serbia, South Africa, Spain, United Kingdom, United States
Scientific Title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease
EudraCT Number
Not available for this trial
    Sorry, this information is not available
Other Study ID Numbers
Janssen Research & Development, LLC
Key Dates

Recruitment Start Date

Sep 2011

Recruitment End Date

Jun 2015

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

07 Jun 2011

Last Updated

28 Oct 2015