A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

This is a multicenter study in pediatric participants aged 2 to 17 years with moderately to
severely active UC, defined as a baseline Mayo score of 6 through 12, inclusive, with an
endoscopy subscore of greater than or equal to (>=)2. This 54-week study will consist of a
6-week short-term phase and a 48-week long-term phase followed by a study extension (Week 54
to end of study). At Week 58, participants who are eligible will continue receiving golimumab
in the study extension. The primary hypothesis is that golimumab is an effective therapy in
pediatric UC relative to historical placebo control as assessed by clinical remission based
on Mayo score. Safety will be monitored throughout the study.

Inclusion Criteria:

- Must either be currently receiving treatment with, or have a history of having failed
to respond to, or have a medical contraindication to at least 1 of the following
therapies: oral or intravenous corticosteroids, 6-mercaptopurine, methotrexate or
azathioprine OR must either have or have had a history of corticosteroid dependency
(that is an inability to successfully taper corticosteroids without a return of the
symptoms of ulcerative colitis [UC]) OR required more than 3 courses of
corticosteroids in the past year

- Moderately to severely active UC (as defined by baseline Mayo score of 6 through 12
[endoscopy {sigmoidoscopy or colonoscopy} sub score assigned by local endoscopist],
inclusive), including a (sigmoidoscopy or colonoscopy) sub score greater than or equal
to (>=2)

- If receiving parenteral or enteral nutrition, must have been on a stable regimen for
at least 2 weeks prior to the first administration of study intervention at Week 0

- No history of latent or active tuberculosis prior to screening

- Acceptable evidence of immunity to measles, mumps, rubella, and varicella

Exclusion Criteria:

- History of liver or renal insufficiency; significant cardiac, vascular, pulmonary,
gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric
(including suicidality), or metabolic disturbances

- History of malignancy or macrophage activation syndrome (MAS) or hemophagocytic
lymphohistiocytosis (HLH)

- Have UC limited to the rectum only or to <20 percent (%) of the colon

- Presence of a stoma

- Presence or history of a fistula

- Contraindications to the use of golimumab or infliximab or anti-tumor necrosis factor
(TNF-alpha) therapy per local prescribing information