NCT00168753

Community Based Trial for AMEVIVE®

An Open-Label Community-Based Study to Determine the Safety and Efficacy of an Extended Course of Alefacept, Following a Standard 12-Week Course of Amevive®, With Commonly Used Clinical Assessment Tools

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety of treating subjects with up to 12 additional doses of alefacept.

Detailed description

Male and female subjects at least 18 years of age with moderate to severe plaque psoriasis treated with 12 weeks of alefacept 15 mg IM and who have not achieved the desired response. Dosing Groups: Subjects will receive either 4, 8, or 12 doses of alefacept 15 mg IM weekly immediately (within 14 days) following a standard 12-dose course of AMEVIVE® 15 mg IM. Determination of number of doses will be based on physician qualitative assessment at weeks 4 and 8.

Conditions

• Moderate to Severe Chronic Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Alefacept	IM

Timeline

• Start date: 2004-07-01
• Primary completion: 2005-03-01
• Completion: 2005-03-01
• First posted: 2005-09-15
• Last updated: 2014-09-08

Locations

36 sites across 1 country: United States