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Etanercept and Methotrexate in Combination or as Monotherapy in Psoriatic Arthritis

NCT02376790 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 851

Last updated 2022-09-21

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-03
Primary Completion
2018-01-09
Completion
2018-07-06

Countries

  • United States
  • Argentina
  • Bulgaria
  • Canada
  • Chile
  • Czechia
  • France
  • Greece
  • Hungary
  • Latvia
  • Mexico
  • Poland
  • Portugal
  • Puerto Rico
  • Russia
  • South Africa
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02376790 on ClinicalTrials.gov