A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1)
Condition: Crohn's Disease; IBD; Colitis; Inflammatory Bowel Disease
MeSH terms: Crohn Disease; Inflammatory Bowel Diseases
Intervention: Group 2 ustekinumab 130 mg; Group 3: ustekinumab approximately 6 mg/kg; Group 1: Placebo
Intervention description: Type=exact, unit=mg, number=130, form=solution for injection, route= intravenous use, in a single dose.; 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).; Form=solution for injection, route=intravenous use, in a single dose.
Intervention MeSH terms: Ustekinumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 769.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ustekinumab; moderately to severely active Crohn's Disease; tumor necrosis factor, Stelara; Crohn; Crohn's; IBD; UNITI

Summary:

      This study (UNITI-1) will compare the effects (both positive and negative) of an initial
      treatment with ustekinumab to placebo over 8 weeks, in patients with moderately to severely
      active Crohn's disease who have either failed or could not tolerate at least one
      TNF-antagonist medications in the past (specifically, infliximab, adalimumab, or certolizumab
      pegol).
    

Eligibility 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's Disease Activity Index
             (CDAI) score of >= 220 and <= 450

          -  Have received infliximab, adalimumab, or certolizumab pegol at a dose approved for the
             treatment of Crohn disease and did not respond initially (ie, primary nonresponse)

          -  Or responded initially but then lost response with continued therapy (ie, secondary
             nonresponse)

          -  Or were intolerant to the medication

          -  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)