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)

This study (CNTO1275CRD3001 or "UNITI-1") examines ustekinumab (an antibody medication that
inhibits the inflammatory proteins IL-12 and IL-23) versus a placebo (otherwise identical
except without the ustekinumab antibody) given intravenously (by an IV) in adults with
moderately to severely active Crohn's disease who previously did not respond to, lost
response to, or could not tolerate TNF-antagonist medications (specifically, infliximab,
adalimumab or certolizumab pegol). Ustekinumab (also known as Stelara) is approved as a
treatment for the skin condition of moderate to severe plaque-type psoriasis, but this study
will examine if ustekinumab can provide benefit in Crohn's disease and also assess for any
risks or side effects. Both the positive and negative outcomes of IV placebo versus two
different doses of IV ustekinumab will be tracked and compared over eight weeks, in
approximately 703 patients. Patients enrolling in this study will be assigned to one of the 3
treatment groups by chance (randomly, like rolling dice), and all will receive a single IV
administration of study agent at the first study visit (after the screening period), and then
will be asked to return for 3 additional visits through Week 8. Patients who complete this
study through the Week 8 visit and remain eligible can enter the maintenance study
(CNTO1275CRD3003 or "IM-UNITI'' [NCT01369355]), where they will receive additional study
agent, including the administration of ustekinumab in patients who receive placebo in this
study and have not had improvement in their Crohn's disease. Patients who do not enter the
CNTO1275CRD3003 study will have a final safety follow-up visit approximately 20 weeks after
they received study agent when they entered into this study at the Week 0 visit. .All
patients will receive a single intravenous (IV) administration of study drug (either placebo
or ustekinumab) at the first (week 0) visit when they enter the study.There are 3 treatment
groups: Group 1: Placebo; Group 2: ustekinumab 130 mg, Group 3: 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).

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)