A Study to Evaluate the Switch From Etanercept to Infliximab in Subjects With Moderate-to-Severe Psoriasis (Study P05133)
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Infliximab
Intervention description: Infliximab 5 mg/kg IV infusion.
Intervention MeSH terms: Infliximab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy, tolerability, and effect on the quality of life of
      infliximab in adults with moderate-to-severe psoriasis who are resistant to etanercept after
      12 weeks of treatment or have failed 24 weeks of treatment with etanercept. Infliximab will
      be administered as an intravenous infusion of 5 mg/kg at Baseline (Week 0), Visit 3 (Week 2),
      Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
    

Eligibility criteria:

        Inclusion Criteria:

          -  >=18 to 75 years of age at Screening, either sex, and any race.

          -  Diagnosis of moderate-to-severe plaque psoriasis >6 months prior to Screening.

          -  Resistant (after 12 weeks) or failed 24 weeks of etanercept treatment.

          -  Not reached PASI 75 at Screening Visit after 24 weeks of etanercept treatment or
             resistant to etanercept.

          -  Agree to avoid prolonged sun exposure or artificial ultraviolet light sources during
             study.

          -  Satisfy requirements of Screening and tuberculosis (TB) test as specified in protocol.

          -  Chest x-ray at Visit 1 or within 3 months prior to Visit 1 with no evidence of
             malignancy, infection, or fibrosis.

          -  Laboratory tests must be within protocol-specified parameters.

          -  Free of any clinically significant disease that would interfere with study
             evaluations.

          -  Willing to participate and adhere to study procedures by signing written informed
             consent.

          -  Women of childbearing potential and all men must be using adequate birth control
             measures and continue to do so until 6 months after receiving last dose of study
             medication.

          -  Females of childbearing potential must have negative serum pregnancy test at Visit 1
             and negative urine pregnancy test at Visit 2.

        Exclusion Criteria:

          -  Achieve PASI 75 or have BSA <10% after 24 weeks of etanercept.

          -  Current drug-induced psoriasis.

          -  Females who are pregnant or nursing and both males and females who are planning
             pregnancy during study period or during 6 months after receiving last dose of study
             medication.

          -  Previously treated with infliximab.

          -  Currently taking or have taken protocol-specified prohibited drugs within specified
             time frame prior to Baseline.

          -  Congestive Heart Failure (CHF)

          -  Chronic or recurrent infectious disease.

          -  Have or have had serious infection, or been hospitalized or received IV antibiotics
             for this infection during the 2 months prior to Visit 1.

          -  Have or have had opportunistic infection within 6 months prior to Visit 1.

          -  Have or have had herpes zoster infection within 2 months prior to Visit 1.

          -  Human Immunodeficiency Virus (HIV), hepatitis B or C.

          -  History of any clinically significant adverse events (AEs) to murine or chimeric
             proteins or human/murine recombinant products.

          -  Current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic,
             hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological,
             cerebral, or psychiatric disease.

          -  History of demyelinating disease or symptoms suggestive of multiple sclerosis or optic
             neuritis.

          -  Current signs and symptoms or history of systemic lupus erythematosus.

          -  Transplanted organ (exception - corneal transplant >3 months prior to Visit 1).

          -  History of lymphoproliferative disease, including lymphoma, or signs and symptoms
             suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual
             size or location.

          -  Malignancy within previous 5 years (exception - basal cell carcinoma of skin that has
             been treated with no evidence of recurrence).

          -  Unable or unwilling to undergo multiple venipunctures because of poor tolerability or
             lack of easy access to veins.

          -  Have had substance abuse (drug or alcohol) problem within previous 3 years.

          -  History of any clinically significant adverse reactions (including allergic reactions)
             to paracetamol/acetaminophen or histamine H1 receptor antagonist.

          -  In a situation or have a condition that, in opinion of investigator, may interfere
             with optimal participation in study.

          -  Used investigational drugs within 4 weeks of Screening.

          -  Participating in any other clinical study.

          -  Staff personnel directly involved with this study.

          -  Family members of investigational study staff.