Etanercept and Methotrexate in Combination or as Monotherapy in Psoriatic Arthritis

The study will consist of a 30-day screening period, a 48-week double-blind treatment period
and a 30-day safety follow-up period.

At or after week 24, participants with an inadequate response could receive rescue therapy
with etanercept plus methotrexate until the end of the treatment period.

Key Inclusion Criteria:

- Subject must have a diagnosis of psoriatic arthritis (PsA) by the Classification
Criteria for Psoriatic Arthritis (CASPAR) criteria.

- Subject has ≥ 3 tender and ≥ 3 swollen joints at screening and at baseline.

- Subject has an active psoriatic skin lesion

- Subject is naïve to etanercept and any other biologic for the treatment for PsA or
psoriasis.

- Subject has no prior use of methotrexate for PsA.

- Subject has no history of tuberculosis

- Subject has a negative test for tuberculosis, hepatitis B and C.

Exclusion Criteria:

- Subject has known history of alcoholic hepatitis, nonalcoholic steatohepatitis or
immunodeficiency syndromes, including human immunodeficiency virus (HIV) infection.

- Subject has any active infection (including chronic or localized infections) for which
anti-infectives were indicated within 4 weeks prior to the first dose of
investigational product.

- Subject has a serious infection, defined as requiring hospitalization or intravenous
anti-infectives within 8 weeks prior to the first dose of investigational product.