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

Launched by MERCK SHARP & DOHME LLC · May 27, 2008

Keywords

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Gender

ALL

Eligibility criteria

• 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.