Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00116181
Status:
COMPLETED
Last Update Posted:
2011-03-18
First Post:
2005-06-27
Brief Title:
Study to Help Understand the Action of the Drug Etanercept for the Adult Patient With Psoriasis
Sponsor:
Rockefeller University
Organization:
Rockefeller University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators 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 hisher 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None