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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 11, 2008

Interventions

  • Biological: Infliximab
    • Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.

Arms, Groups and Cohorts

  • Experimental: Infliximab 5 mg/kg
    • Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.

Clinical Trial Outcome Measures

Primary Measures

  • Psoriasis Area and Severity Index 75 (PASI75) Response at Week 10
    • Time Frame: 10 weeks
    • 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).

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Merck Sharp & Dohme LLC
  • Provider of Information About this Clinical Study
    • Sponsor

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