A Study of Golimumab in Participants With Active Psoriatic Arthritis

This is a Phase 3, multicenter (when more than one hospital or medical school team work on a
medical research study), randomized (study drug assigned by chance), double-blind (neither
the researchers nor the participants know what treatment the participant is receiving),
placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is
compared in a clinical trial with a drug to test if the drug has a real effect) study of
golimumab compared with placebo in participants with active psoriatic arthritis. The study
will include 4 phases: Screening phase (up to 6 weeks), Double-blind placebo-controlled phase
(Week 0 to Week 24), Active treatment phase (Week 24 to Week 52), and Safety follow-up phase
(8 weeks from last study drug administration). Total duration of the study will be 60 weeks
per participant. Eligible Participants will be randomly assigned to either Treatment Group 1:
Placebo or Treatment Group 2: Golimumab. Participants randomized to Placebo Group, will
receive intravenous infusions of placebo at Weeks 0, 4, 12 and 20. At Week 24, all
participants receiving placebo will begin receiving intravenous infusions of golimumab (2
mg/kg) at Week 24, 28 and thereafter every 8 weeks up to Week 52. Participants randomized to
Golimumab Group, will receive intravenous infusions of golimumab 2 mg/kg at Week 0, 4 and
thereafter every 8 weeks up to Week 52. At Week 24, participants randomized to golimumab
Group will receive a placebo infusion to maintain the blind. The efficacy will be assessed
primarily by measuring percentage of participants who achieve a 20 percent improvement from
baseline in the assessment used in active psoriatic arthritis at Week 14. Participants'
safety will be monitored throughout the study.

Inclusion Criteria:

- Have had psoriatic arthritis (PsA) for at least 6 months prior to the first
administration of study agent

- Have a diagnosis of active PSA as defined by 5 or more swollen joints and 5 or more
tender joints at Screening and at Baseline and C-reactive protein >=0.6 milligram per
deciliter (mg/dL) at Screening

- Have active plaque psoriasis or a documented history of plaque psoriasis

- Have active PsA despite current or previous disease-modifying antirheumatic drugs
(DMARD) and/or nonsteroidal anti-inflammatory drug (NSAID) therapy. DMARD therapy is
defined as taking a DMARD for at least 3 months, or evidence of DMARD intolerance.
NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of NSAID
intolerance

Exclusion Criteria:

- Have other inflammatory diseases that might confound the evaluations of benefit of
Golimumab therapy, including but not limited to rheumatoid arthritis, ankylosing
spondylitis, systemic lupus erythematosus, or Lyme disease

- Are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in
the study or within 4 months after receiving the last administration of study agent

- Have used any biologic agents that are targeted for reducing tumor necrosis factors
(TNF) alpha, including but not limited to Infliximab, Etanercept, Adalimumab,
Golimumab, and Certolizumab Pegol

- Have ever used cytotoxic drugs, including Chlorambucil, Cyclophosphamide, Nitrogen
mustard, or other Alkylating agents