A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)
Condition: Crohn's Disease; Inflammatory Bowel Disease; IBD; Colitis
MeSH terms: Crohn Disease; Colitis; Inflammatory Bowel Diseases
Intervention: Group 1: Placebo; Group 2 ustekinumab 130 mg; Group 3: ustekinumab approximately 6 mg/kg
Intervention description: Form=solution for injection, route=intravenous use, in a single dose.; 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).
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: 640.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: ustekinumab; moderately to severely active Crohn's Disease; Stelara; IBD; colitis; crohn; UNITI; Crohn's

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.
    

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 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)