drugset / Trial / NCT00442650

Efalizumab for Treatment of Patients With Moderate to Severe Psoriasis

NCT00442650

Phase 3 Completed Merck KGaA, Darmstadt, Germany
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Multicentre, open label, phase III study. Subjects with moderate to severe psoriasis were given efalizumab subcutaneously once per week for the 12-week treatment period. Assessments involved physical examination, disease activity assessments, clinical laboratory tests (haematology, blood chemistry and standard urinalysis), evaluation of the Psoriasis Area and Severity Index (PASI), the Physician's Global Assessment (PGA), the Patient's Global Psoriasis Assessment (PGPA), the SF-36 Health Survey and psoriatic body surface area (BSA). The 12-week treatment period was followed by a 12-week follow-up (FU) period, during which other antipsoriatic medications were allowed. The same assessments were also performed in the 12-week FU period.

Timeline

Start
2004-01
Primary completion
2005-12
Completion
2005-12

Drugs

EvaluationDrugModalityDoseRoute
Subject efalizumab Monoclonal antibody 1 mg/kg Subcutaneous

Indications