Controlled Study of Humira in Subjects With Chronic Plaque Psoriasis of the Hands and/or Feet
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Placebo; Adalimumab
Intervention description: Loading dose of 2 placebo subcutaneous (SC) injections (0.8 ml) at Week 0 followed by 1 injection SC eow from Week 1 to Week 15.In second period of study, subjects who continued in the study received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.; Loading dose of 80 mg adalimumab SC (two 40 mg injections) followed by 40 mg adalimumab SC eow.
Intervention MeSH terms: Adalimumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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)