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Study to Help Understand the Action of the Drug Etanercept for the Adult Patient With Psoriasis

NCT00116181 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2011-03-18

No results posted yet for this study

Summary

The investigator's laboratory is studying a skin disease known as psoriasis. The purpose of this protocol is to study the action and the effects of Etanercept, on psoriasis. This medication has been studied extensively and has been found to be effective and safe in the treatment of psoriasis. The eligible patient will have 10% of his/her body surface area involved with psoriasis vulgaris. This trial is a phase III study to help understand the action of the drug etanercept, trade name Enbrel, for the adult patient with moderate to severe plaque psoriasis and who is a candidate for internal medications.

Conditions

Interventions

DRUG

Etanercept

All subjects will administer etanercept 50 mg twice weekly subcutaneously (2 injections of 25 mg etanercept SC within 1 hour twice weekly) for the first 12 weeks of study. Subjects randomized to the "continuous therapy" arm will then receive 50 mg once weekly SC (2 injections of 25 mg etanercept SC within 1 hour once weekly) for weeks 13 through 24. Subjects randomized to the "intermittent therapy" arm will be assessed for response. Those who achieve a responder status on the PGA (PGA score £ 2 and improved from baseline) at week 12 will discontinue therapy. Upon relapse of PGA responder status, etanercept will be administered 50 mg once weekly SC (2 injections of 25 mg etanercept SC within 1 hour once weekly) through week 24.

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Rockefeller University

    lead OTHER

Principal Investigators

  • James G. Krueger, MD, PHD · Rockefeller University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2007-01-31

Countries

  • United States

Study Locations

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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 NCT00116181 on ClinicalTrials.gov