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The Efficacy and Safety of Adding Methotrexate to Etanercept in Psoriasis

NCT01001208 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 478

Last updated 2013-08-12

Study results available
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Summary

The purpose of this study is to evaluate the efficacy of adding methotrexate to etanercept compared with etanercept monotherapy as measured by the percentage of participants achieving a 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI 75) at Week 24.

Conditions

Interventions

DRUG

Methotrexate

Methotrexate tablets over-encapsulated for blinding

DRUG

Etanercept

1 mL for subcutaneous injection

DRUG

Placebo

Matching placebo to methotrexate capsules

Sponsors & Collaborators

  • Immunex Corporation

    collaborator INDUSTRY

  • Amgen

    lead INDUSTRY

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-12-31
Completion
2011-02-28

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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 NCT01001208 on ClinicalTrials.gov