A Study to Evaluate Infliximab in Subjects With Moderate-to-Severe Psoriasis Not Responding to Standard or Biologic Therapy (Study P04612)
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Infliximab
Intervention description: Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
Intervention MeSH terms: Infliximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 215.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      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).
    

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.