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

Phase 2

Completed

• Conditions: Psoriatic Arthritis
• Interventions: Drug: Methotrexate; Drug: Alefacept; Drug: Placebo

• Registration Number: NCT00659412
• Lead Sponsor: Astellas Pharma Inc

Brief 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.

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2005-03
• Study Completion: 2005-03
• Study First Submitted: 2008-04-14
• Study First Submitted QC: 2008-04-15
• Study First Posted: 2008-04-16
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-17
• Last Update Posted: 2014-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Course A2	Placebo	-
Course A2	Methotrexate	-
Course A1	Alefacept	-
Course B	Methotrexate	Open-label extension
Course A1	Methotrexate	-
Course B	Alefacept	Open-label extension

Primary Outcome Measures

Name	Time	Method
Proportion of patients achieving a score in the assessment system of the American College of Rheumatology Core Set Measurements of ACR 20, ACR 50 and ACR 70	12 Weeks and at any time

Secondary Outcome Measures

Name	Time	Method
Proportion of patients achieving a score in the Psoriasis Area and Severity Index of PASI 75, PASI 50 and PASI 25	Each scheduled efficacy visit
Proportion of patients achieving a classification in the Physician's Global Assessment (PGA) of clear/almost clear	Each scheduled efficacy visit
Sharp -VanDen Heijde Modified Score of Joint Damage (X-ray)	Baseline, 24 Weeks and 48 Weeks