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

Astellas Pharma Inc185 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

185

Conditions

Psoriatic Arthritis

Interventions

AlefaceptDRUG

Intramuscular

MethotrexateDRUG

Oral

PlaceboDRUG

Intramuscular

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (27)

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Wheaton, Maryland, United States

Outcomes

Primary Outcomes

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

Time frame: 12 Weeks and at any time

Secondary Outcomes

Proportion of patients achieving a score in the Psoriasis Area and Severity Index of PASI 75, PASI 50 and PASI 25

Time frame: Each scheduled efficacy visit

Proportion of patients achieving a classification in the Physician's Global Assessment (PGA) of clear/almost clear

Time frame: Each scheduled efficacy visit

Sharp -VanDen Heijde Modified Score of Joint Damage (X-ray)

Time frame: Baseline, 24 Weeks and 48 Weeks

Data from ClinicalTrials.gov

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