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

A Multicenter, Open-Label, Prospective Study to Evaluate the Effectiveness and Safety of Etanercept in the Treatment of Subjects With Psoriasis-EASE in Psoriasis

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Etanercept

Detailed Description

The eligible patient will receive the drug Etanercept (Enbrel), and will self inject with Etanercept twice a week for the first 12 weeks. The patient will be taught to self inject the medication at home and will be seen in the clinic weekly, for the first four weeks and then once a month.

During the second 12 weeks of the study, patients will be placed in one of two groups by the drug company participating. One group of patients will be randomized to either continue receiving the medication and will self inject once a week. A second group will be randomized to not receive the medication but will continue to be followed and examined at monthly visits. The drug company will do the randomization or choice of group, and each patient has a one in two chance of being placed in one group or the other.

At the clinic visits, the patient can expect that a physical exam and skin exam will be done. At specific weeks, blood work will be drawn, clinical photography taken and a skin biopsy done. Two types of skin biopsies will be done after local anesthesia has been administered. One is a punch biopsy where a small piece of skin will be taken, the approximate size of a pencil eraser. The second type of skin biopsy is a shave biopsy, where a postage sized piece of skin will be taken.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Rockefeller University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Gender: Male and Female
• Minimum Age: 18
• Maximum Age: 70

Exclusion Criteria:

• Healthy Volunteers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: continuous therapy; Subjects will receive 50 mg once weekly SC (2 injections of 25 mg etanercept SC within 1 hour once weekly) for weeks 13 through 24.	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.
Active Comparator: intermittent therapy; Subjects 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects achieving a responder status on the Physician's Global Assessment (PGA) at week 24	screening, baseline, week 2, 4, 12, 16, 20 and 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Subject incidence rates of serious adverse events, serious infections, non-melanoma skin cancer, and all malignancies	measured over 24 weeks

Collaborators and Investigators

• Sponsor: Rockefeller University
• Collaborators: Amgen
• Investigators: Principal Investigator: James G. Krueger, MD, PHD, Rockefeller University

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Primary Completion (Actual): January 1, 2007

Study Registration Dates

• First Submitted: June 27, 2005
• First Submitted That Met QC Criteria: June 27, 2005
• First Posted (Estimate): June 28, 2005

Study Record Updates

• Last Update Posted (Estimate): March 18, 2011
• Last Update Submitted That Met QC Criteria: March 16, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Etanercept
• Other Study ID Numbers: JKR 542