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 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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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
James G. Krueger, MD, PHD
United States: Food and Drug Administration
|Rockefeller University||New York, New York 10021|