An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis

This was a Phase 3, multicenter (conducted in more than one center), placebo-controlled (an
inactive substance that is compared with a drug to test whether the drug has a real effect
in a clinical trial), double-blind (neither the Physician nor the participant know about the
study medication), parallel-group (a medical research study comparing the response in 2 or
more groups of participants receiving different interventions), randomized-withdrawal study.
Participants who were in clinical response to golimumab at Week 6 in induction study
C0524T16 (NCT00488774) or C0524T17 (NCT00487539) will be randomly assigned in a 1:1:1 ratio
at Week 0 of this study to receive 1 of the following maintenance treatment regimens
administered subcutaneously every 4 weeks through Week 52: placebo, golimumab 50 mg, or
golimumab 100 mg. Participants who were in clinical response to placebo and participants who
were not in clinical response to golimumab or placebo at Week 6 in induction study C0524T16
(NCT00488774) or C0524T17 (NCT00487539) will not be randomly assigned but will be eligible
to be enrolled in the study (i.e., the nonrandomized group) and received the following
treatment regimens: placebo, golimumab 100 mg and golimumab 100 mg. Dose adjustment will be
done for participants who were in clinical response to golimumab or placebo during induction
studies C0524T16 (NCT00488774) or C0524T17 (NCT00487539) but lose clinical response during
maintenance study C0524T18 (NCT00488631). On completing this study, participant will have
the opportunity to continue to receive study medication in a study extension that will last
up to approximately 3 years. Efficacy will be primarily evaluated by assessing the clinical
response using Mayo Score. Participants' safety will be monitored throughout the study.

Inclusion Criteria:

- Participants who received all study agent administrations and completed the Week 6
Mayo score evaluation in induction study C0524T16 (NCT00488774) or C0524T17
(NCT00487539)

- Participants who completed the Week 0 visit for this maintenance study C0524T18
(NCT00488631) on the same day as the Week 6 visit of the induction study C0524T16
(NCT00488774) or C0524T17 (NCT00487539)

Exclusion Criteria:

- Participants who increased the dose of their concomitant (given at the same time) UC
medications since Week 0 of induction study C0524T16 (NCT00488774) or C0524T17
(NCT00487539)

- Participants who initiated a concomitant UC medication since Week 0 of an induction
study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)

- Participants who had a partial or total colectomy (surgery to remove part or all of
the colon) or an ostomy (surgical construction of an artificial opening (stoma) for
external fistulization of a duct or vessel by insertion of a tube with or without a
supportive stent) since Week 0 of an induction study C0524T16 (NCT00488774) or
C0524T17 (NCT00487539)

- Participants with signs or symptoms of latent or active granulomatous infection
(including TB); a nontuberculous mycobacterial infection or opportunistic infection;
or infection with HIV (Human Immunodeficiency Virus), hepatitis B, or hepatitis C

- Participants with signs and symptoms of any malignancy or suggestive of a possible
lymphoproliferative disease (disorders characterized by proliferation of lymphoid
tissue, general or unspecified)