for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:



The purpose of this study is to learn more about the role of etanercept alone or in combination with methotrexate on disease activity in subjects with psoriatic arthritis. To do this, etanercept alone will be compared to methotrexate alone or to combination etanercept and methotrexate.This study will last approximately 1 year (52 weeks) for an individual subject. Subjects will be randomized into 1 of 3 groups. Subjects will have a 1 in 3 chance of receiving etanercept plus methotrexate, etanercept alone or methotrexate alone. Neither the subject nor the study doctor can choose the group to which the subject will be randomized into. Subjects will take one study medication by injection under their skin and a second medication taken by mouth. After the first 24 weeks of the study, if the doctor evaluates the subject and determines that their condition has not improved, the subject may qualify to receive etanercept plus methotrexate.

Official Title

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


This is a multicenter, randomized, double-blind controlled study to evaluate the efficacy of etanercept plus methotrexate therapy and etanercept monotherapy compared to methotrexate monotherapy, in subjects with PsA as measured by the proportion of subjects achieving an American College of Rheumatology (ACR) 20 response and Minimal Disease Activity (MDA) at week 24.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. Approximately 840 subjects will be randomly assigned in a 1:1:1 ratio to one of three treatment groups (280 per group): etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 20 mg weekly, etanercept 50 mg weekly by subcutaneous injection plus oral placebo for methotrexate, and oral methotrexate 20 mg weekly plus placebo for etanercept. Starting at week 24 visit, subjects who have an inadequate response will be provided rescue treatment of etanercept plus methotrexate for the remainder of the study.


Psoriatic Arthritis Arthritis, Psoriasis Etanercept Enbrel Methotrexate Minimal Disease Activity Arthritis Arthritis, Psoriatic Etanercept + Oral Methotrexate Etanercept & Methotrexate Combo Etanercept Mono Methotrexate Mono


For people ages 18 years and up

Key Inclusion Criteria:

  • Subject must have a diagnosis of 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 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.


  • Research Site
    San Francisco California 94143 United States
  • Research Site
    Mather California 95655 United States
  • Research Site
    Thousand Oaks California 91360 United States
  • Research Site
    Los Angeles California 90095 United States
  • Research Site
    Santa Monica California 90404 United States
  • Research Site
    Tustin California 92780 United States
  • Research Site
    Las Vegas Nevada 89128 United States
  • Research Site
    Hemet California 92543 United States
  • Research Site
    Palm Desert California 92260 United States
  • Research Site
    Escondido California 92025 United States


in progress, not accepting new patients
Start Date
Completion Date
AmgenTrials clinical trials website
Phase 3
Study Type
Last Updated
April 18, 2018