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

Psoriatic Arthritis Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00659412
Study type Interventional
Source Astellas Pharma Inc
Contact
Status Completed
Phase Phase 2
Start date September 2003
Completion date March 2005
View Details
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