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Completed

NCT Number: NCT00659412

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

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.

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Key information

Conditions

Psoriatic Arthritis Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Victoria, British Columbia, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alefacept

Drug

Intramuscular

Other names: Amevive, ASP0485

methotrexate

Drug

Oral

Placebo

Drug

Intramuscular

Primary outcomes

  1. 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

  1. 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

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

    Time frame: Each scheduled efficacy visit

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

    Time frame: Baseline, 24 Weeks and 48 Weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Biogen

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Apr 16, 2008
Registry last updated
Sep 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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