An Open-label Study to Evaluate the Efficacy of Re-treatment for Patients With a History of Etanercept Use

Inclusion Criteria:

- Subjects with psoriasis who have previously been treated with etanercept for a
minimum of 6 months and discontinued treatment due to loss of efficacy. Every attempt
will be made to obtain loss of efficacy history from the subject's medical chart;when
etanercept was commenced and terminated and description of patient's psoriasis on
termination and details of new treatment commenced. Subjects must have failed their
latest psoriasis treatment after a period of three months. This will be measured as a
PGA of ≥ 3.

- There is no specific requirement as to when prior treatment with etanercept occurred
and no requirement as to what type of treatment(s) used between initial and
subsequent treatments.

- Are ≥ 18 years of age

- PGA ≥ 3

- BSA minimum of 5%

Tuberculosis inclusion criteria

- Have no history of latent or active TB prior to screening.

- Have no signs or symptoms suggestive of active TB upon medical history and/or
physical examination.

- Have had no recent close contact with a person with active TB.

- Within 1 month prior to the first administration of study have a negative tuberculin
skin test.

- The ability to give written informed consent and comply with study procedures.

Exclusion Criteria:

- Current enrollment in any other investigational device or investigational drug
trial(s), or receipt of any other investigational agent(s) within 28 days before
baseline visit.

- Known hypersensitivity to Enbrel® (etanercept) or any of its components or known to
have antibodies to etanercept.

- Latex sensitivity [NB: only applicable if they are using prefilled syringe or
prefilled SureClick™ autoinjector presentations]

- Prior or concurrent use of cyclophosphamide therapy

- Concurrent sulfasalazine therapy.

- A positive HBV test or known history of any other immuno-suppressing disease.

- Any mycobacterial disease or high risk factors for tuberculosis (TB), such as family
member with TB, positive purified protein derivative (PPD) or taking
anti-tuberculosis medication.

- Active or chronic infection within 4 weeks before screening visit, or between the
screening and baseline visits.

- History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection and
Hepatitis C, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome,
chronic recurring infections or active TB, or other opportunistic infections

- If etanercept was previously discontinued due to a serious adverse event

- Severe comorbidities (diabetes mellitus requiring insulin; CHF of any severity; or
myocardial infarction, cerebrovascular accident or transient ischemic attack within 6
months of screening visit; unstable angina pectoris; uncontrolled hypertension
(sitting systolic BP <80 mm Hg or > 160 or diastolic BP > 100 mm Hg);
oxygen-dependent severe pulmonary disease; history of cancer within 5 years [other
than resected cutaneous basal or squamous cell carcinoma of the skin or in situ
cervical cancer])

- Systemic lupus erythematosus, history of multiple sclerosis, transverse myelitis,
optic neuritis or seizure disorder.

- Use of a live vaccine 90 days prior to screening visit, or concurrent use of a live
vaccine.

- Any condition or circumstances judged by the patient's physician [or the investigator
or medically qualified study staff] to render this clinical trial detrimental or
otherwise unsuitable for the patient's participation.

- Female subjects who are pregnant, nursing or planning pregnancy (both men and women)
and not using acceptable methods of birth control during the trial (hormonal,
barriers, abstinence).

- Women who are breast feeding

History of non-compliance with other therapies.

- History of alcohol abuse within the last 12 months

- Concurrent use of anakinra

- Subjects who cannot discontinue any of the drugs below for 2 weeks prior to the
baseline visit or during the study;

A two week wash out period is appropriate as it would be unethical to expect subjects
whose disease if flaring to remain untreated for a longer period of time. The first dose
of etanercept will be administered two weeks after the last biologic dose.

- Immunosuppressants, antimalarials, or sulfasalazine.

- Other Ani-TNFs

- Cyclosporine

- Efalizumab

- Azathioprine

- Hydroxyurea

- Live vaccines

- Tacrolimus

- Oral retinoids (isotretinoin,acitretin,bexarotene)

- Ultra violet light therapies