Etanercept and Methotrexate in Combination or as Monotherapy in Psoriatic Arthritis

• Status: Completed
• Trial end date: 2018-07-06
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Etanercept; Methotrexate

Criteria

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.