Study to Help Understand the Action of the Drug Etanercept for the Adult Patient With Psoriasis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Psoriasis	Drug: Etanercept	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Multicenter, Open-Label, Prospective Study to Evaluate the Effectiveness and Safety of Etanercept in the Treatment of Subjects With Psoriasis-EASE in Psoriasis

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Etanercept

U.S. FDA Resources

Further study details as provided by Rockefeller University:

Primary Outcome Measures:

Proportion of subjects achieving a responder status on the Physician's Global Assessment (PGA) at week 24 [ Time Frame: screening, baseline, week 2, 4, 12, 16, 20 and 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Subject incidence rates of serious adverse events, serious infections, non-melanoma skin cancer, and all malignancies [ Time Frame: measured over 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	30
Study Start Date:	October 2004
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Healthy Volunteers

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116181

Locations

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

Sponsors and Collaborators

Rockefeller University

Amgen

Investigators

Principal Investigator:

James G. Krueger, MD, PHD

Rockefeller University

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	James Krueger, MD, Rockefeller University
ClinicalTrials.gov Identifier:	NCT00116181 History of Changes
Other Study ID Numbers:	JKR 542
Study First Received:	June 27, 2005
Last Updated:	March 16, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013