Safety and Efficacy of Infliximab in Palmoplantar Psoriasis

Inclusion Criteria

• Patient is 18 years of age or older.
• Patient has a history of palmoplantar psoriasis for at least 6 months.
• Patient has a m-PPPASI of at least 8 with at least 10% of the total surface of palms and soles affected with psoriasis at baseline
• Patients who failed either 4 weeks (or more) of treatment with a potent or superpotent topical corticosteroid, methotrexate, acitretin, cyclosporine, efalizumab, etanercept or alefacept for the treatment of palmoplantar psoriasis. Patients with a positive PPD who accept TB prophylaxis, will need to have failed 4 weeks (or more) of treatment with methotrexate, acitretin, cyclosporine, efalizumab, etanercept, alefacept or any other systemic therapies for the treatment of palmoplantar psoriasis.
• Patient with a history and/or the presence of typical plaque psoriasis outside palms and soles
• Female patient is either not of childbearing potential or is of childbearing potential and practicing an acceptable contraception
• Female patients of childbearing potential must have a negative serum pregnancy test at the Screening visit.
• Patient is judged to be in good general health as determined by the principal investigator based upon the results of medical history, laboratory profile, and physical examination performed at Screening
• The investigator evaluates that the benefit / risk ratio is acceptable for the patient.
• Patients must be able and willing to provide written informed consent and comply with the requirements of this study protocol.
• Negative PPD
• Patients with a positive PPD may be eligible if they initiate TB prophylaxis before the first injection of infliximab

Exclusion Criteria

• Patient has a history of pustules on palms and/or soles or currently has evidence of pustules on palms and/or soles.
• Patient with Chest X Ray findings positive or suspicious for active tuberculosis.
• Patient has had opportunistic infections.
• Patient has had active TB or recent close contact with an individual with active TB.
• Patient has had a serious infection, has been hospitalized for an infection, or has been treated with intravenous (IV) antibiotics for an infection within 2 months prior to Day 0.
• Patient has had a chronic or recurrent infectious disease including hepatitis B or hepatitis C.
• Patient has a known malignancy or history of malignancy within 5-year period prior to screening (with the exception of squamous or basal cell carcinoma of the skin that has been completely excised without evidence of recurrence).
• Patient has a history of lymphoproliferative disease, has multiple sclerosis, or other central demyelinating disorder, or congestive heart failure.
• Patient has elevated aspartate aminotransferase or alanine aminotransferase levels more than twice the upper limit of normal at screening.
• Patient has received live vaccination within 3 months of randomization or plans to receive live vaccination during the study or within 3 months after the last infusion.
• Patient is pregnant, breastfeeding, or planning pregnancy (both men and women) during the trial or within the 6-month period thereafter.
• Patient has a history of an allergic reaction to infliximab or any constituent of study drug.
• Patient who has used any topical treatment for psoriasis (except non-medicated emollients) in the last 2 weeks before Day 0 with the exception of hydrocortisone and desonide for the face, groin (including genitals) and inframammary areas as well as shampoos containing tar, salicylic acid or zinc pyrithione
• Patient who has used UVB phototherapy or excessive sun exposure less than 14 days before Day 0.
• Patient has used any non-biological systemic therapy for the treatment of psoriasis (including PUVA therapy), systemic steroids or systemic immunosuppressants less than 28 days before Day 0. Investigational non-biologics agents must be discontinued at least 28 days or 5 half-lives prior to Day 0 (whichever is longer).
• Patient is currently participating in a