A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2) | Completed
A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)
Health Conditions
  • Crohn's Disease
  • Inflammatory Bowel Disease
  • IBD
  • Colitis
Completed
Recruitment Status
NCT01369342
Primary Trial ID Number
Summary
This study (UNITI-2) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to a placebo over 8 weeks in patients with moderately to severely active Crohn's disease.
Primary Outcome Measures
  • Clinical Response; Week 6
Secondary Outcome Measures
  • Clinical remission; Week 8; Clinical improvement/response; Study visits through Week 8
Research Question
  • This study (UNITI-2) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to a placebo over 8 weeks in patients with moderately to severely active Crohn's disease.
Design Type
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Ethics Approval
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Publications
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Countries of Recruitment
United States; Australia; Belgium; Brazil; Bulgaria; Canada; Croatia; France; Germany; Hungary; Iceland; 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
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Participant Inclusion Criteria
  • Inclusion Criteria:
  • - Have Crohn's disease of at least 3 months' duration with colitis, ileitis, or
  • ileocolitis, confirmed at some time in the past by radiography, histology, or
  • endoscopy
  • - Have active Crohn's disease, defined as a baseline Crohn Disease Activity Index
  • (CDAI) score of >= 220 and <= 450, with confirmation of active inflammation
  • - Has failed conventional therapy as demonstrated by having received corticosteroids
  • and/or immunomodulators(ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR
  • Have a history of failure to respond to or tolerate an adequate course of
  • corticosteroids and/or immunomodulators (ie, AZA, MTX, or 6-MP) at adequate
  • therapeutic doses OR Is corticosteroid dependent or has had a history of
  • corticosteroid dependency AND Has not previously demonstrated failure of or
  • intolerance to 1 or more TNF-antagonist therapies (ie, infliximab, adalimumab, or
  • certolizumab pegol) per study criteria
  • - Have screening laboratory test results within protocol-specified parameters
  • Exclusion Criteria:
  • - Patients who have had any kind of bowel resection within 6 months
  • - Are pregnant or planning pregnancy (both men and women) while enrolled in the study
  • or for 20 weeks after receiving study agent
  • - Patients who have received infliximab, adalimumab or certolizumab pegol < = 8 weeks
  • before the first administration of study drug
  • - Patients with certain complications of Crohn's disease that would make it hard to
  • assess response to study drug
  • - Patients with a history of or ongoing chronic or recurrent infectious disease
  • - Patients who have previously received a biologic agent targeting IL-12 or IL-23,
  • including but not limited to ustekinumab (CNTO 1275) or briakinumab (ABT-874)
Participant Exclusion Criteria
  • Inclusion Criteria:
  • - Have Crohn's disease of at least 3 months' duration with colitis, ileitis, or
  • ileocolitis, confirmed at some time in the past by radiography, histology, or
  • endoscopy
  • - Have active Crohn's disease, defined as a baseline Crohn Disease Activity Index
  • (CDAI) score of >= 220 and <= 450, with confirmation of active inflammation
  • - Has failed conventional therapy as demonstrated by having received corticosteroids
  • and/or immunomodulators(ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR
  • Have a history of failure to respond to or tolerate an adequate course of
  • corticosteroids and/or immunomodulators (ie, AZA, MTX, or 6-MP) at adequate
  • therapeutic doses OR Is corticosteroid dependent or has had a history of
  • corticosteroid dependency AND Has not previously demonstrated failure of or
  • intolerance to 1 or more TNF-antagonist therapies (ie, infliximab, adalimumab, or
  • certolizumab pegol) per study criteria
  • - Have screening laboratory test results within protocol-specified parameters
  • Exclusion Criteria:
  • - Patients who have had any kind of bowel resection within 6 months
  • - Are pregnant or planning pregnancy (both men and women) while enrolled in the study
  • or for 20 weeks after receiving study agent
  • - Patients who have received infliximab, adalimumab or certolizumab pegol < = 8 weeks
  • before the first administration of study drug
  • - Patients with certain complications of Crohn's disease that would make it hard to
  • assess response to study drug
  • - Patients with a history of or ongoing chronic or recurrent infectious disease
  • - Patients who have previously received a biologic agent targeting IL-12 or IL-23,
  • including but not limited to ustekinumab (CNTO 1275) or briakinumab (ABT-874)
Interventions
Drug; Group 3: ustekinumab approximately 6 mg/kg; Type=range, unit=mg/kg, number=6, form=solution for injection, route= intravenous use, in a single dose.weight-range based ustekinumab doses approximating ustekinumab 6 mg/kg: 260 mg (weight <= 55 kg), 390 mg (weight > 55 kg and <= 85 kg), and 520 mg (weight > 85 kg).; [003]; Drug; Group 1: Placebo; Form=solution for injection, route=intravenous use, in a single dose.; [001]; Drug; Group 2 ustekinumab 130 mg; Type=exact, unit=mg, number=130, form=solution for injection, route= intravenous use, in a single dose.; [002]
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 Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease (UNITI-2)
Secondary Trial Identifying Number
CNTO1275CRD3002; 2010-022759-42
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

02 Jul 2015

Date Record Refreshed on UKCTG

31 Jul 2015