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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

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 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

Details

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.

Keywords

Psoriatic Arthritis Arthritis, Psoriasis Etanercept Enbrel Methotrexate Minimal Disease Activity

Eligibility

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.

Locations

  • Research Site accepting new patients
    Mather, California, 95655, United States
  • Research Site completed
    Thousand Oaks, California, 91360, United States
  • Research Site completed
    Santa Monica, California, 90404, United States
  • Research Site accepting new patients
    Los Angeles, California, 90095, United States
  • Research Site accepting new patients
    Tustin, California, 92780, United States
  • Research Site completed
    Las Vegas, Nevada, 89128, United States
  • Research Site accepting new patients
    Hemet, California, 92543, United States
  • Research Site accepting new patients
    Palm Desert, California, 92260, United States
  • Research Site accepting new patients
    Escondido, California, 92025, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amgen
Links
AmgenTrials clinical trials website
ID
NCT02376790
Phase
Phase 3
Study Type
Interventional
Last Updated
June 1, 2017