Controlled Study of Humira in Subjects With Chronic Plaque Psoriasis of the Hands and/or Feet
Controlled Study of Humira in Subjects With Chronic Plaque Psoriasis of the Hands and/or Feet
Evaluate the efficacy and safety of a 16-week course of Humira (adalimumab) compared to
 placebo in adults with chronic plaque psoriasis of the hands and/or feet and the
 sustainability of response for 12 additional weeks.
Inclusion Criteria:

 -  Adult with Diagnosis of chronic plaque psoriasis of the Hands and Feet for at least 6
 months, with a PGA >/=3 and candidates for systemic therapy;

 -  Patients in good general health

 -  Able to self-administer injections

 -  Negative chest x-ray (CXR) and purified protein derivative (PPD) test, unless willing
 to start anti-tuberculosis (TB) prophylaxis

 Exclusion Criteria:

 -  Previous treatment with HUMIRA®

 -  Required mediation stability or washouts for: systemic corticosteroids (28 days),
 other investigational agent, other systemic therapies for psoriasis, ultraviolet B
 (UVB), psoralen with UVA (PUVA)

 -  Other active skin diseases or skin infections

 -  Diagnosis of palmoplantar pustulosis; erythrodermic psoriasis, pustular psoriasis,
 medication-induced or exacerbated psoriasis or new onset of guttate psoriasis

 -  Evidence of dysplasia or history of malignancy (Other than a successfully treated
 non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in
 situ of the cervix);

 -  History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection, human
 immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring
 infections or active tuberculosis (TB);

 -  History of moderate to severe congestive heart failure,

 -  Recent cerebrovascular accident and any other condition which, in the opinion of the
 investigator, would put the subject at risk;

 -  History of central nervous system (CNS) demyelinating disease or neurologic symptoms
 suggestive of CNS demyelinating disease;

 -  History of clinically significant drug or alcohol abuse in the last 12 months;

 -  Infection(s) requiring treatment with intravenous (IV) antibiotics, IV antivirals, or
 IV antifungals within 30 days prior to Baseline or oral antibiotics, oral antivirals,
 or oral antifungals within 14 days prior to Baseline;

 -  Known hypersensitivity to the excipients of HUMIRA® as stated in the label;

 -  Female subjects who are pregnant or breast-feeding or considering becoming pregnant
 during the study.

 -  Prior exposure to Tysabri® (natalizumab)