Safety and Efficacy of Etanercept in Patients With Psoriasis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate safety and efficacy of etanercept in patients with psoriasis who had an unsatisfactory response to traditional DMARDs.

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: Etanercept
* Drug: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: has plaque psoriasis and has shown an unsatisfactory response to traditional DMARDs 18 to 75 years old has PGA of 3 or more at Day 0 has BSA of 3% or more at Day 0 has psoriasis severe enough to be eligible to systemic therapy willing to use an effective method of contraception for at least 30 days before Day 0 and until at least 1 month after the last drug administration; capable of giving informed consent with normal or non clinically significant chest X-ray within 6 months prior to Day 0 with negative Purified Protein Derivative (PPD) or Quantiferon TB Gold test within 90 days prior to Day 0 female patients of childbearing potential have a negative serum pregnancy test patient is able to start etanercept per the approved product monograph Exclusion Criteria: has used topical steroids, topical tar preparations, or other anti-psoriatic preparations within the two weeks prior to Day 0 or during the study period has presence of erythrodermic, pustular or guttate psoriasis has had significant infections within the 30 days prior to Day 0 has received investigational drugs within the four weeks prior to screening or during the study period has been treated with systemic anti-psoriatic drugs such as steroids, retinoids, cyclosporine, PUVA therapy or methotrexate within the four weeks prior to Day 0 or during the study period received systemic antibiotics within the four weeks prior to Day 0 has been treated with ultraviolet light therapy (UVB, nbUVB) within the two weeks prior to Day 0 or during the study period has used infliximab within 14 days of Day 0 or during the study period has used other biologic agents for the treatment of psoriasis besides etanercept 8 weeks prior to Day 0 or during the study period has had an allergic reaction to infliximab has an unstable or serious medical condition as defined by the investigator or presence of any significant medical condition that might cause this study to be detrimental to the patient uncontrolled or severe comorbidities such as poorly controlled diabetes mellitus, NYHA class III or IV heart failure, history of myocardial infarction or cerebrovascular accident or transient ischemic attack within three months of screening visit; unstable angina pectoris uncontrolled hypertension, oxygen-dependent severe pulmonary disease has a known sero-positivity for HIV virus or history of any other immunosuppressive disease has active or chronic Hepatitis B or C has any mycobacterial disease, patient with a chest X-Ray suggestive of tuberculosis or patient taking anti-tuberculosis medication has a known hypersensitivity to etanercept or one of its components has received a live attenuated vaccine within the 12 weeks prior to Day 0 or plans to receive one during the study current pregnancy or lactation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Etanercept<br>Patients under the treatment of 50 mg Etanercept | Drug: Etanercept<br> <br> |
| Sham Comparator: Control<br>Patients under the treatment of traditional DMARDs | Drug: Control<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline of Physician's Global Assessment (PGA) at 24 weeks |  | At 0 week, 12 weeks, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Body Surface Area (BSA) |  | At 0 week, 12 weeks, 24 weeks | 
| Mean Psoriasis Area and Severity Index (PASI) |  | At 0 week, 12 weeks, 24 weeks |