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

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: March 2005

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

  • Drug: Alefacept
    • Intramuscular
  • Drug: Methotrexate
    • Oral
  • Drug: Placebo
    • Intramuscular

Arms, Groups and Cohorts

  • Experimental: Course A1
  • Placebo Comparator: Course A2
  • Experimental: Course B
    • Open-label extension

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Astellas Pharma Inc
  • Collaborator
    • Biogen
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Use Central Contact, Study Director, Astellas Pharma US, Inc.

References

Mease PJ, Gladman DD, Keystone EC; Alefacept in Psoriatic Arthritis Study Group. Alefacept in combination with methotrexate for the treatment of psoriatic arthritis: results of a randomized, double-blind, placebo-controlled study. Arthritis Rheum. 2006 May;54(5):1638-45. doi: 10.1002/art.21870.

Mease PJ, Reich K; Alefacept in Psoriatic Arthritis Study Group. Alefacept with methotrexate for treatment of psoriatic arthritis: open-label extension of a randomized, double-blind, placebo-controlled study. J Am Acad Dermatol. 2009 Mar;60(3):402-11. doi: 10.1016/j.jaad.2008.09.050. Epub 2008 Nov 25. Erratum In: J Am Acad Dermatol. 2009 Sep;61(3):507.

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