Etanercept and Methotrexate in Combination or as Monotherapy in Psoriatic Arthritis



Status:Completed
Conditions:Arthritis, Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:3/8/2019
Start Date:March 3, 2015
End Date:July 6, 2018

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A Multicenter Double-Blind, Randomized Controlled Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects With Psoriatic Arthritis

The purpose of this study is to learn more about the role of etanercept alone or in
combination with methotrexate on disease activity in adults with 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.
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56
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Charleston, South Carolina 29412
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Charlotte, North Carolina 28207
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Ciudad Autónoma de Buenos Aires, Buenos Aires
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Duncansville, Pennsylvania 16635
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