CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 851 enrolled
Drug / intervention
Etanercept +3 moredrug
Likely dose
Methotrexate 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02376790
NCT02376790Phase 3Completed

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

Amgen·interventional·Posted Mar 3, 2015·Updated Sep 21, 2022

In Brief

A Phase 3 clinical trial evaluating Etanercept, Methotrexate, and 2 other interventions for Psoriatic Arthritis. Completed, enrolled 851 participants across 138 sites in 18 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Bulgaria, Canada, Chile, Czechia, France, Greece, Hungary, Latvia, Mexico, Poland, Portugal, Puerto Rico, Russia, South Africa, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 3, 2015
Enrollment StartMar 3, 2015
Primary CompletionJan 9, 2018
Study CompletionJul 6, 2018
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 11.3 years ago

Interventions

Etanerceptdrug

Etanercept was administered by subcutaneous injection once a week

Methotrexatedrug

Methotrexate capsules taken orally once a week. Dosing was initiated at 10 mg weekly and titrated up to a final dose of 20 mg weekly over a 4-week period.

Placebo to Etanerceptdrug

Placebo to etanercept was administered by subcutaneous injection once a week.

Placebo to Methotrexatedrug

Placebo to methotrexate capsules taken orally once a week.