Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year

This study compares the safety and efficacy of ustekinumab versus adalimumab. It will consist
of screening (within 1- 5 weeks prior to Week 0), treatment phase (Weeks 0 to 52), and
follow-up phase (up to Week 76). The primary hypothesis is that ustekinumab is superior to
adalimumab as measured by clinical remission after one year of treatment. Study assessments
will include Crohn's disease activity index (CDAI), video ileocolonoscopy; CD-related
healthcare utilization; patient-reported outcomes (PROs); laboratory evaluations; biomarkers;
review of concomitant medications and adverse events (AEs); and evaluation of serum
concentrations of study agent as well as development of antibodies to study agent. All
participants will randomly be assigned to receive either ustekinumab or adalimumab. No
participants will be treated with placebo only.

Inclusion Criteria:

- Has Crohn's Disease (CD) or fistulizing CD of at least 3 months' duration, with
colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography,
histology, and/or endoscopy

- Has moderately-to-severely active CD with a baseline Crohn's disease activity index
(CDAI) score of greater than or equal to (>=) 220 and less than or equal to (<=) 450

- Has one or more ulceration on screening ileocolonoscopy (which by definition, would
result in an Simple Endoscopic Score for Crohn's Disease [SES-CD] of at least 3)

- Has failed or was intolerant to conventional therapy (corticosteroids, azathioprine
[AZA], 6-mercaptopurine [6-MP] and/or methotrexate [MTX]) at adequate doses or is
corticosteroid dependent

- Has not previously received an approved biologic for Crohn's Disease (i.e.,
infliximab, adalimumab, certolizumab pegol, ustekinumab, natalizumab, vedolizumab or
approved biosimilars of these agents)

- Participants on oral corticosteroids (e.g., prednisone, budesonide) at a
prednisone-equivalent dose of <=40 or milligram/day (mg/day) or <=9 mg/day of
budesonide are budesonide <=9 mg/day are permitted if doses are stable for 3 weeks
prior to baseline

- Participants on AZA, 6-MP, or MTX at screening (or recently prior), must discontinue
these medications at least 3 weeks prior to baseline

Exclusion Criteria:

- Has complications of CD that are likely to require surgery or would confound the
ability to assess the effect of ustekinumab or adalimumab treatment using the CDAI,
such as: active stoma; short-gut syndrome and severe or symptomatic strictures or
stenosis

- Currently has, or is suspected to have, an abscess. Recent cutaneous and perianal
abscesses are not exclusionary if drained and adequately treated at least 3 weeks
prior to baseline, or 8 weeks prior for intra-abdominal abscesses, if there is no
anticipated need for any further surgery. Participants with active fistulas may be
included if there is no anticipation of a need for surgery and there are currently no
abscesses present

- Has had any kind of bowel resection within 6 months prior to baseline or other
intra-abdominal surgery or a hospital admission for bowel obstruction within 3 months
prior to baseline

- Has a stool culture or other examination positive for an enteric pathogen, including
Clostridium difficile toxin, in the last 4 months unless a repeat examination is
negative and there are no signs of ongoing infection with that pathogen

- Has received a Bacillus Calmette-Guerin (BCG) vaccination within 12 months or any
other live bacterial or live viral vaccination within 2 weeks of baseline

- Has a history of, or ongoing, chronic or recurrent infectious disease, including but
not limited to, chronic renal infection, chronic chest infection, recurrent urinary
tract infection (eg, recurrent pyelonephritis or chronic nonremitting cystitis), or
infected skin wounds or ulcers