NCT02376790

Etanercept and Methotrexate in Combination or as Monotherapy in Psoriatic Arthritis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 851 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Psoriatic Arthritis

Interventions

Type	Name	Description
DRUG	Etanercept	Etanercept was administered by subcutaneous injection once a week
DRUG	Methotrexate	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.
DRUG	Placebo to Etanercept	Placebo to etanercept was administered by subcutaneous injection once a week.
DRUG	Placebo to Methotrexate	Placebo to methotrexate capsules taken orally once a week.

Timeline

• Start date: 2015-03-03
• Primary completion: 2018-01-09
• Completion: 2018-07-06
• First posted: 2015-03-03
• Last updated: 2022-09-21
• Results posted: 2019-02-22

Locations

138 sites across 18 countries: United States, Argentina, Bulgaria, Canada, Chile, Czechia, France, Greece, Hungary, Latvia, Mexico, Poland, Portugal, Puerto Rico, Russia, South Africa, Spain, United Kingdom