a study to evaluate the switch from etanercept to infliximab in subjects with moderate-to-severe psoriasis (study p05133)

Conditions: Psoriasis

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.