NCT00659412

A Placebo-controlled Study With an Extension Examining the Safety and Efficacy of Alefacept in Psoriatic Arthritis

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Alefacept When Given in Combination With Methotrexate in Subjects With Psoriatic Arthritis With an Open-label Retreatment Course

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 185 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Randomized, double-blind, 24-week study of patients with psoriatic arthritis comparing alefacept + methotrexate (MTX) vs. placebo + MTX followed by a 24-week open-label extension with only alefacept + MTX treatment.

Detailed description

Patients who completed the initial 24-week treatment course and met the inclusion and exclusion criteria for the 24 week open-label extension continued on their stable MTX dose and also received alefacept throughout this extension.

Conditions

• Psoriatic Arthritis

Interventions

Type	Name	Description
DRUG	Alefacept	Intramuscular
DRUG	Methotrexate	Oral
DRUG	Placebo	Intramuscular

Timeline

• Start date: 2003-09-01
• Primary completion: 2005-03-01
• Completion: 2005-03-01
• First posted: 2008-04-16
• Last updated: 2014-09-18

Locations

27 sites across 5 countries: United States, Canada, Germany, Poland, Russia