A Study to Evaluate Infliximab in Subjects With Moderate-to-Severe Psoriasis Not Responding to Standard or Biologic Therapy (Study P04612)

Study Overview
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Brief Summary
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Subjects with moderate-to-severe chronic psoriasis not responding to standard or biologic therapy will be eligible to enroll in this study. Subjects will receive infliximab infusions (5 mg/kg of body weight) at Weeks 0, 2, 6, and 14 followed by a 12-week follow-up period. The efficacy of infliximab will be evaluated by the Psoriasis Area and Severity Index (PASI).

Official Title
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A Multi-center, Open Label Trial Evaluating the Efficacy , SAfety and the Impact on QUAlity of Life of Infliximab TherapY in Patients With Moderate-to-severe Psoriasis Not Responding to Standard or Biologic Therapy

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 to 75 years of age, of either gender, and of any race. Psoriasis covering at least 10% of total body surface area (BSA) and PASI >=12 at Screening and Baseline. Diagnosis of moderate-to-severe psoriasis at least 6 months prior the screening. Eligible to infliximab who have failed at least 1 of the following: corticosteroids, methotrexate (MTX), systemic retinoids, cyclosporine, psoralen-ultraviolet A (PUVA), ultraviolet B (UVB) phototherapy, and/or biologics (etanercept or efalizumab). Eligible according to tuberculosis (TB) eligibility assessment, screening and early detection of reactivation rules. Chest x-ray within 3 months prior to Screening with no evidence of malignancy, infection, or fibrosis. Screening and Baseline tests (complete blood count [CBC], blood chemistry, and urinalysis) must be within protocol-specified parameters. Free of significant disease that could interfere with study evaluations. Willing to give written informed consent and able to adhere to protocol visits and procedures. Women of childbearing potential and all men must be using adequate birth control and must continue to do so for 6 months after receiving the last dose of study medication. Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline. Exclusion Criteria: Standard concomitant psoriasis therapies. Active or latent TB. History of chronic infectious disease, opportunistic infection, or serious infection within 2 months of enrollment. History of lymphoproliferative disease. Malignancy in past 5 years (except treated basal cell carcinoma [BCC]). Treatment with tumor necrosis factor (TNF) antagonists within previous 6 weeks. Current drug-induced psoriasis. Females who are pregnant or nursing and females and males who are planning pregnancy within 6 months from the last infusion of infliximab. Previously treated with infliximab. Concomitant diagnosis of congestive heart failure (CHF) including medically-controlled asymptomatic subjects. History of chronic or recurrent infectious disease. Have or have had a serious infection or have been hospitalized or received intravenous antibiotics for an infection during the 2 months prior to Screening. Have or have had an opportunistic infection within 6 months prior to Screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 administered as an infusion at Weeks 0, 2, 6, and 14. | Biological: Infliximab<br>* Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).<br>* Other names: Remicade, SCH 215596;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Achieve a Greater Than or Equal to 75% Improvement in Psoriasis Area and Severity Index (PASI) Score | 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 responses 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 |