Clinical trial NCT00116181: Study to Help Understand the Action of the Drug Etanercept for the Adult Patient With Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Lead sponsor: Rockefeller University
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2005-06-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Healthy Volunteers

Primary outcomes:
measure: Proportion of subjects achieving a responder status on the Physician's Global Assessment (PGA) at week 24
timeFrame: screening, baseline, week 2, 4, 12, 16, 20 and 24
Secondary outcomes:
measure: Subject incidence rates of serious adverse events, serious infections, non-melanoma skin cancer, and all malignancies
timeFrame: measured over 24 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Rockefeller University
state: New York
Study officials:
affiliation: Rockefeller University
name: James G. Krueger, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: