A Study to Evaluate the Accuracy of a Subset of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

The study drug, golimumab, belongs to a group of medicines known as tumor necrosis factor
(TNF) inhibitors and is approved in the United States, European Union, and Canada for
treatment of UC. Studies have shown that people respond differently to treatment with TNF
inhibitors and furthermore, some people may not actually respond to treatment. Tests which
could predict the likelihood of response to golimumab prior to treatment would be of benefit
to people with UC. This is an open label (physicians and participants know the identity of
the assigned treatment), multicenter study to evaluate the accuracy of a genetic test (a
subset of the length-109 probe set panel) in predicting response to golimumab treatment in
patients with moderately to severely active UC. The study will consist of a screening phase,
an open label treatment phase (Week 0 to Week 50), and a follow-up visit at Week 58. A
subset of the length-109 probe set panel will be tested on samples obtained from colonic
biopsies taken prior to treatment with golimumab for all participants at screening. All
participants enrolled in the study will receive subcutaneous golimumab from Week 0 to Week
50; at the discretion of the investigator, participants will be given the option to
self-administer golimumab from Week 6 onwards. Blood and fecal samples will be taken at
various time points during the study; colonic biopsies will be taken at screening, Week 6,
and Week 30; and endoscopies will be performed at Week 0, Week 6, and Week 30. The study
duration for each participant is expected to be approximately 58 weeks. Participant safety
will be monitored throughout the study.

Inclusion Criteria:

- Must have the following: a clinical diagnosis of moderately to severely active
ulcerative colitis (UC), defined as a baseline Mayo score of 6 to 12 (inclusive), for
at least 3 months prior to screening; and a screening endoscopy with a > = 2
endoscopy sub score of the Mayo score as determined by a central reading of the video
endoscopy

- Prior or current medication for UC must be as per protocol

- Prior to the screening endoscopy or the earliest entry in the Mayo diary card
(whichever of these 2 events comes first) the following conditions must be met: per
protocol requirements for treatment with 6-mercaptopurine, azathioprine, or
methotrexate; per protocol requirements for treatment with oral 5-aminosalicylate or
oral corticosteroids; treatment must have been discontinued for at least 2 weeks for
rectal corticosteroids, rectal 5-aminosalicylate compounds, parenteral
corticosteroids, total parenteral nutrition, pentoxifylline, thalidomide or related
agents, and antibiotics for the treatment of UC; and treatment with 6-thioguanine
must have been discontinued for at least 4 weeks

- Must have had a colonoscopy as per the time frame described in the protocol for the
following: extensive colitis for > = 8 years; disease limited to the left side of the
colon for > = 10 years; participants > = 45 years of age to assess for the presence
of adenomatous polyps

- Must meet the tuberculosis and hepatitis B virus screening criteria as defined in the
protocol

Exclusion Criteria:

- The presence of any of the following: severe extensive colitis; UC limited to the
rectum only or to <20 cm of the colon; a stoma; a fistula (or history of a fistula);
symptomatic colonic or small bowel obstruction; adenomatous colonic polyps (or
history of adenomatous colonic polyps); or indeterminate colitis or clinical findings
suggestive of Crohn's disease

- History of extensive colonic resection (eg, less than 30 cm of colon remaining) or
colonic mucosal dysplasia; requires (or has required within the 2 months prior to
screening) surgery for active gastrointestinal bleeding, peritonitis, intestinal
obstruction, intra abdominal or pancreatic abscess requiring surgical drainage

- Have received the following concomitant or previous medical therapies: biologic
therapy targeted at tumor necrosis factor alpha (eg, infliximab, adalimumab,
golimumab, etanercept, certolizumab); natalizumab within 12 months of first golimumab
administration; agents that deplete B- or T-cells (eg, rituximab, alemtuzumab, or
visilizumab) within 12 months of first golimumab administration, or continue to
manifest depletion of B- or T-cells more than 12 months after completion of therapy
with lymphocyte depleting agents; cyclosporine, tacrolimus, sirolimus, or
mycophenolate mofetil within 8 weeks prior to first administration of golimumab;
vedolizumab within 8 weeks prior to first golimumab administration; apheresis (ie,
Adacolumn apheresis) within 2 weeks prior to first administration of golimumab; any
investigational drug within 4 weeks prior to first administration of golimumab or
within 5 half-lives of the investigational agent, whichever is longer; or oral
corticosteroids at a dose of greater than 40 mg of prednisone or its equivalent per
day

- Have received, or are expected to receive, any live viral or bacterial vaccination
within 8 weeks (or longer as indicated in the package insert of the relevant vaccine)
prior to the first administration of golimumab or have had Bacille Calmette-Guerin
(BCG) vaccination within 12 months of screening

- History of, or currently active illness, considered to be clinically significant by
the Investigator or any other illness that the Investigator considers should exclude
the participant from the study or that could interfere with the interpretation of the
study results