Eligibility

Ages Eligible for Study

19 years and up

Genders Eligible for Study

Both

Keywords

psoriasis, melanoma, non-melanoma skin cancer, etanercept, and Enbrel

Sponsors

Industry

Amgen

Other

University of Alabama at Birmingham

Inclusion Criteria

1. Diagnosis of moderate to severe plaque psoriasis identified by a BSA greater than or
equal to 10% and a PASI score greater than or equal to 12

2. Age 19 years or above

3. Fitzpatrick skin type I, II or III

4. Candidate for systemic treatment in the opinion of the investigator

5. Willingness to undergo treatment with Enbrel as outlined above

6. Negative pregnancy test (urine or serum β-HCG) before the first dose of study drug in
all women (except those surgically sterile, or at least 5 years postmenopausal).

7. Negative TB skin test at entry into the study or a negative screening x-ray in
inconclusive PPD reading (borderline, reactive but non-diagnostic) or in prior BCG
inoculated subjects.

8. Sexually active subjects of childbearing potential must agree to use medically
acceptable form of contraception during screening and throughout the study

9. Subject or designee must have the ability to self-inject study medication or have a
care giver at home who can administer subcutaneous injections

10. Must be able and willing to give written informed consent and comply with the
requirements of the study protocol and must authorize release and use of protected
health information

Exclusion Criteria

1. Serum creatinine > 3.0 mg/dL (265 micromoles/L)

2. Serum potassium < 3.5 mmol/L or > 5.5 mmol/L

3. Serum ALT or AST > 3 times the upper limit of normal for the Lab

4. Platelet count < 100,000/mm3

5. WBC count < 3,000 cells/mm3

6. Hemoglobin, hematocrit, or red blood cell count outside 30% of the upper or lower
limits of normal for the Lab

7. Systemic therapy use (e.g. phototherapy, methotrexate, cyclosporine, oral steroids,
systemic biologics) within the previous 4 weeks

8. Topical therapy use (e.g. topical steroids, vitamin D derivatives) within the
previous 2 weeks

9. Subject is currently enrolled in another investigational device or drug trial(s), or
subject has received other investigational agent(s) within 28 days of baseline visit.

10. Subjects who have known hypersensitivity to Enbrel or any of its components or who is
known to have antibodies to etanercept

11. Prior or concurrent cyclophosphamide therapy

12. Concurrent sulfasalazine therapy

13. Known HIV-positive status or known history of any other immunosuppressing disease

14. Active severe infections within 4 weeks before screening visit, or between the
screening and baseline visits

15. Untreated Lyme disease

16. Severe comorbidities (diabetes mellitus requiring insulin, CHF of any severity, MI,
CVA or TIA within 3 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 or in situ cervical cancer])

17. History of TB or TB exposure, chronic hepatitis B or hepatitis C, SLE, history of
multiple sclerosis, transverse myelitis, optic neuritis or epilepsy

18. History of recent alcohol or substance abuse (< 1 year)

19. Pregnant or lactating females

20. Use of a live vaccine 90 days prior to, or during this study

21. Any condition judged by the patient's physician to cause this clinical trial to be
detrimental to the patient

22. History of non-compliance with other therapies

Detailed Description

In psoriasis patients, thick psoriatic plaques can obscure these lesions, and clinicians rely heavily on visual inspection to recognize suspicious or atypical pigmented lesions. However, successful systemic treatment and subsequent clearing of psoriatic plaques may allow clinicians to better evaluate pigmented lesions, thereby increasing the likelihood of early identification and treatment of suspicious lesions such as nonmelanoma skin cancer and malignant melanoma.