A Study to Evaluate Remicade (Infliximab) in Moderate-to-Severe Chronic Plaque Psoriasis in the Middle Eastern Population (Study P04528)
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Infliximab
Intervention description: Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
Intervention MeSH terms: Infliximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Middle Eastern subjects with moderate-to-severe chronic plaque psoriasis will be administered
      infusions of infliximab (Remicade) at 5 mg/kg of body weight at Weeks 0, 2, 6, 14, and 22.
      The safety and efficacy of infliximab monotherapy will be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older, either gender, and any race.

          -  Psoriasis affecting >=5% of body surface, PASI score >=10 (maximum score 72).

          -  History of plaque psoriasis for >6 months.

          -  Informed written consent.

          -  Refractory to other anti-psoriasis agents (topical corticosteroids, phototherapy UVa
             [PUVA], or systemic therapy).

          -  Negative chest x-ray and purified protein derivative (PPD) within 1 month.

          -  Understand and be able to adhere to dosing and visit schedules.

          -  Screening laboratory tests must meet protocol-specified criteria.

          -  Women and men of childbearing potential must be using adequate birth control measures
             and should continue such precautions for 6 months after last infusion of infliximab.

        Exclusion Criteria:

          -  Pregnant, nursing, or planned pregnancy within 6 months after last scheduled
             treatment.

          -  Used topical corticosteroids in previous 14 days or systemic therapy (phototherapy UVb
             [UVB], PUVA, cyclosporine, methotrexate) in previous 28 days, or received treatment
             with anti-tumor necrosis factor (TNF)-alpha monoclonal antibodies, human or murine
             immunoglobulins, TNF-alpha receptor fusion proteins, or other bioengineered fusion
             proteins.

          -  Received previous immunobiologics.

          -  Have HIV, hepatitis B or C.

          -  Recently transplanted (exception - corneal transplant >3 months prior to first
             infusion) or known malignancy or history of malignancy within previous 5 years
             (exception - basal or squamous cell carcinoma of skin that has been treated with no
             evidence of recurrence).

          -  Concurrent medications that are not permitted.

          -  congestive heart failure (CHF)

          -  Use of cyclosporine or tacrolimus within 4 weeks prior to Screening.

          -  Use of intramuscular (IM), intravenous (IV), or oral corticosteroids within 4 weeks
             prior to Screening.

          -  Treatment with any investigational drug within 3 months prior to Screening.

          -  Allergy to murine proteins.

          -  Serious infections (hepatitis, pneumonia, pyelonephritis) in previous 3 months.

          -  History of active tuberculosis (TB) requiring treatment within previous 3 years, or
             history of opportunistic infections (herpes zoster) within 2 months of Screening.

          -  Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic,
             hematologic, endocrine, pulmonary, cardiac, neurological or cerebral disease.

          -  Current signs or symptoms of other severe uncontrolled disease which in investigator's
             opinion would put the subject at an unacceptable risk.

          -  History of current alcohol or drug abuse.

          -  Not observed designated washout periods for any of the prohibited medications in
             protocol.