A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI) | 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)
Health Conditions
  • Crohn's Disease
  • Colitis
  • IBD
  • Inflammatory Bowel Disease
Recruiting
Recruitment Status
NCT01369355
Primary Trial ID Number
Summary
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.
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
Research Question
  • 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.
Design Type
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Ethics Approval
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Publications
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Countries of Recruitment
United States; 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
Participant Sex
Both
Participant Age Range
18 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
1310
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
  • 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
Interventions
Drug; Placebo; Responders to ustekinumab: Form=solution for injection, route=Subcutaneous use. One SC injection q4w; [001]; Drug; Ustekinumab; Responders to ustekinumab: Form=solution for injection, route=Subcutaneous use. One SC injection q12w; [002]; Drug; Ustekinumab; Responders to ustekinumab: type=1, unit=mg, number=90, form=solution for injection, route=Subcutaneous use. One SC injection q8w; [003]; Drug; Ustekinumab; Nonresponders to IV induction ustekinumab: type=1, unit=mg, number=90, form=solution for injection, route=Subcutaneous use. One SC injection at Week 0; [004]; Drug; Ustekinumab; if then respond, one SC injection q8w; [005]
Design Details
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Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Results Reporting
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Acronym
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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
Secondary Trial Identifying Number
CNTO1275CRD3003; 2010-022760-12
Website
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Study Funded By
Janssen Research & Development, LLC
Funder Type
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Study Sponsored By
Janssen Research & Development, LLC
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

07 Jun 2011

Last Updated

22 Jul 2015

Date Record Refreshed on UKCTG

24 Jul 2015