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

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: Biogen
• Treatments: Alefacept; Methotrexate

Criteria

Inclusion Criteria:

• Psoriatic arthritis

• MTX treatment for 3 months prior to enrollment with continuing disease

• Normal T-cell count

Exclusion Criteria:

• Other types of psoriasis

• History of malignancy or lymphoproliferative disorder

• Serious infection or fever

• Antibody positive for Hepatitis C, HIV or TB

• Hepatic transaminases > 2X normal