A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of
Subcutaneously Administered Golimumab, a Human anti-TNFα Antibody, in Pediatric
Subjects With Moderately to Severely Active Ulcerative Colitis

Golimumab is a fully human monoclonal antibody with an IgG1 heavy chain isotype
(G1m[z] allotype) and a kappa light chain isotype. Golimumab binds to human
tumor necrosis factor alpha (TNFα) with high affinity and specificity and
neutralizes TNFα bioactivity.
Golimumab has been shown to be safe and efficacious in adults with moderately
to severely active ulcerative colitis (UC). Golimumab has the potential to
offer pediatric patients with moderately to severely active UC a safe and
effective therapy with a convenient subcutaneous (SC) injection option given
every 4 weeks (q4w).

The primary study objectives are as follows:
-To evaluate the pharmacokinetics (PK) of golimumab in pediatric subjects aged
2 through 17 years with moderately to severely active UC.
-To evaluate the safety of golimumab in pediatric subjects aged 2 through 17
years with moderately to severely active UC.
An additional objective is to evaluate the efficacy of golimumab induction (ie,
short-term therapy) in pediatric subjects aged 2 through 17 years with
moderately to severely active UC.

This is a multicenter, open-label study to assess the PK and safety of
golimumab treatment in pediatric subjects aged 2 through 17 years with
moderately to severely active UC, defined as a baseline Mayo score of 6 through
12, inclusive, with an endoscopy subscore of >= 2. The study will be divided
into 2 parts: the PK portion of the study and the study extension.
-PK portion: Subjects will receive induction dose regimens of SC golimumab at
Week 0 and Week 2 based on body weight. At Week 6, all subjects will be
evaluated for clinical response; subjects in clinical response will continue to
receive open label golimumab maintenance therapy and will have the opportunity
to participate in the study extension that begins at Week 14. Subjects not in
clinical response at Week 6 will be withdrawn from further study agent
administration.
-Study Extension: Subjects in clinical response at Week 6 will continue to
receive open label golimumab maintenance therapy and will enter the study
extension at Week 14. During the study extension, subjects will receive
golimumab maintenance therapy every 4 weeks (q4w) through Week 110.
-At Week 114, subjects who, in the opinion of the investigator, may benefit
from continued treatment will be eligible to continue to receive golimumab q4w
under this protocol until marketing authorization is obtained for golimumab in
the treatment of pediatric UC in that country, or until a decision has been
made not to pursue an indication in pediatric UC, whichever occurs first.
An internal Safety Monitoring Committee, consisting of a clinician and a
statistician at a minimum, will monitor the safety data of the subjects in this
study on an ongoing basis.

The study will be divided into 2 parts: the PK portion of the study and the
study extension.
-PK portion: Subjects will receive induction dose regimens of SC golimumab at
Week 0 and Week 2.
-Study Extension: Subjects in clinical response at Week 6 will continue to
receive open label golimumab maintenance therapy and will enter the study
extension at Week 14. During the study extension, subjects will receive
golimumab maintenance therapy every 4 weeks (q4w) through
Week 110.
At Week 114, subjects who, in the opinion of the investigator, may benefit from
continued treatment will be eligible to continue to receive golimumab q4w under
this protocol.

Possible burden of the patient, related to the testing of the study will be
tests, will be such as Sigmoidoscopy, but this could also be standard procedure
of testing for patients with ulcerative colitis. Sigmoidoscopy and tests such
as the tuberculosis test can be experienced as unpleasant.
Further burden will be blood sampling and the visit days throughout the study,
during which childeren will be accompanied by their parents/guardians.