A Study to Evaluate Remicade (Infliximab) in Moderate-to-Severe Chronic Plaque Psoriasis in the Middle Eastern Population (Study P04528)

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Multinational, Open Label Study on the Efficacy and Safety of Infliximab Monotherapy in Moderate-to-severe Chronic Plaque Psoriasis in Middle Eastern Population

Conditions
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Psoriasis

Intervention / Treatment
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* Biological: Infliximab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infliximab 5 mg/kg<br>Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22. | Biological: Infliximab<br>* Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.<br>* Other names: Remicade, SCH 215596;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis Area and Severity Index 75 (PASI75) Response at Week 10 | PASI 75 response is defined as participants who achieved at least a 75% improvement in PASI score from Baseline to Week 10. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease). | 10 weeks |