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

Astellas

Status and phase: Completed; Phase 2

Conditions: Psoriatic Arthritis

Treatments: Drug: Placebo; Drug: Methotrexate; Drug: Alefacept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00659412

C-737

Details and patient eligibility

About

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.

Full 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.

Enrollment: 185 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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185 participants in 3 patient groups, including a placebo group

Course A1

Experimental group

Treatment:

Drug: Alefacept

Drug: Methotrexate

Course A2

Placebo Comparator group

Treatment:

Drug: Methotrexate

Drug: Placebo

Course B

Experimental group

Description:

Open-label extension

Treatment:

Drug: Alefacept

Drug: Methotrexate