Safety and Efficacy of Infliximab in Palmoplantar Psoriasis
Condition: Palmoplantar Psoriasis
MeSH terms: Psoriasis
Intervention: Placebo; Infliximab
Intervention description: Patients receive placebo on weeks 0, 2 and 6. They receive infliximab 5mg/kg at weeks 14, 16 and 20.; Patients in infliximab group receive infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22. Patients in placebo then infliximab group receive placebo at weeks 0, 2, 6, then receive infliximab at weeks 14, 16 and 20.
Intervention MeSH terms: Infliximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Palmoplantar psoriasis; Infliximab

Summary:

      Palmoplantar psoriasis is a variant of psoriasis affecting palms and soles. It is one of the
      most debilitating variants of psoriasis which very often interferes with daily activities and
      with the ability to work. This type of psoriasis is very difficult to treat as topicals have
      difficulty penetrating the thick epidermis of palms and soles and are therefore not very
      effective. The response to standard agents (methotrexate, cyclosporine and acitretin) is also
      usually limited. A number of these patients have very severe hand and feet disease with mild
      to no involvement elsewhere on the body.

      Given the efficacy of infliximab in psoriasis, the purpose of this study is to evaluate if
      infliximab is safe and if it will improve severity and quality of life in patients with
      palmoplantar psoriasis, a debilitating variant of psoriasis.
    

Eligibility criteria:

        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 clinical trial with an experimental drug or
             device.

          -  Patient who has used any biological therapy for the treatment of psoriasis less than
             90 days before day 0.

          -  Patient is taking or requires oral or injectable corticosteroids during the study.
             Inhaled corticosteroids for stable medical conditions are allowed. Patients who have
             used oral or injectable corticosteroids less than 28 days before Day 0 are excluded.

          -  Patient has a poorly controlled medical condition which, in the opinion of the
             investigator, would put the patient at risk if the patient participated in the study.

          -  Patient currently uses or plans to use anti-retroviral therapy at any time during the
             study.

          -  Patient is known to have immune deficiency or is immunocompromised.

          -  Patient is known to be infected with the human immunodeficiency virus, hepatitis B or
             hepatitis C virus.

          -  Patient has current signs or symptoms or has a history of systemic lupus
             erythematosus.

          -  Patient has a history of clinically significant drug or alcohol abuse in the last
             year.

          -  Patient has erythrodermic psoriasis, generalized or localized pustular psoriasis,
             medication-induced or medication-exacerbated psoriasis.

          -  Patients with a positive PPD who accept TB prophylaxis must not have any pre-existing
             liver disease.