NCT00336973

A Study to Evaluate Raptiva in Subjects With Chronic Moderate or Worse Plaque Psoriasis Who Have Had an Inadequate Response to an Anti-TNF Agent

A Phase IV Open-Label Study to Evaluate the Efficacy and Safety of 1.0 mg/kg Raptiva (Efalizumab) in Adult Subjects With Chronic Moderate or Worse Plaque Psoriasis Who Have Had an Inadequate Response to an Anti-TNF Agent

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase IV open-label study to evaluate the efficacy and safety of SC efalizumab in adult subjects (18 years of age and older) with chronic moderate or worse plaque psoriasis who have had an inadequate response to treatment with an anti-TNF agent. The study will consist of a screening period, a treatment period, and an observation period. All subjects will begin in the screening period (the length of which is dependent on the previous anti-TNF agent treatment). Approximately 100 eligible subjects will receive treatment from Day 0 through Day 168.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	efalizumab	Subcutaneous repeating dose

Timeline

• Start date: 2006-05-01
• Primary completion: 2008-02-01
• First posted: 2006-06-15
• Last updated: 2015-07-23
• Results posted: 2009-06-05