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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00659412

Enrollment

185

Registered

2008-04-16

Start date

2003-09-30

Completion date

2005-03-31

Last updated

2014-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriatic Arthritis

Keywords

Psoriatic arthritis, psoriasis, Alefacept

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.

Interventions

DRUGAlefacept

Intramuscular

DRUGMethotrexate

Oral

DRUGPlacebo

Intramuscular

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Canada, Germany, Poland, Russia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026