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

September 17, 2014 updated by: Astellas Pharma Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

185

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8V 3P9
    • Newfoundland and Labrador
      • St Johns, Newfoundland and Labrador, Canada, A1C 5B8
    • Ontario
      • London, Ontario, Canada, N6A 4V2
      • Newmarket, Ontario, Canada, L3Y 3R7
      • Toronto, Ontario, Canada, M5T 2S8
      • Toronto, Ontario, Canada, K1N 5N1
    • Quebec
      • Montreal, Quebec, Canada, H2L 1S6
  • Germany
      • Berlin, Germany, D-13125
      • Frankfurt, Germany, D-60590
      • Goettingen, Germany, D-37075
  • Poland
      • Bialystok, Poland, 15-337
      • Elblag, Poland, 82-300
      • Kalisz, Poland, 62-800
      • Krakow, Poland, 30-119
      • Torun, Poland, 87-100
      • Warszawa, Poland, 02-637
  • Russian Federation
      • Moscow, Russian Federation, 115522
      • Moscow, Russian Federation, 107076
      • N. Novgorod, Russian Federation, 603600
      • St Petersburg, Russian Federation, 190068
      • St. Petersburg, Russian Federation, 194044
      • Yaroslavl, Russian Federation, 150003
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
    • Maryland
      • Wheaton, Maryland, United States, 20902
    • New York
      • Lake Success, New York, United States, 11042
      • Rochester, New York, United States, 14642
    • Washington
      • Seattle, Washington, United States, 98104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Course A1
Drug: Alefacept
Intramuscular
Other Names:
  • Amevive, ASP0485
Drug: Methotrexate
Oral
PLACEBO_COMPARATOR: Course A2
Drug: Methotrexate
Oral
Drug: Placebo
Intramuscular
EXPERIMENTAL: Course B
Open-label extension
Drug: Alefacept
Intramuscular
Other Names:
  • Amevive, ASP0485
Drug: Methotrexate
Oral

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: 12 Weeks and at any time
12 Weeks and at any time

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Each scheduled efficacy visit
Sharp -VanDen Heijde Modified Score of Joint Damage (X-ray)
Time Frame: Baseline, 24 Weeks and 48 Weeks
Baseline, 24 Weeks and 48 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

Biogen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (ACTUAL)

March 1, 2005

Study Completion (ACTUAL)

March 1, 2005

Study Registration Dates

First Submitted

April 14, 2008

First Submitted That Met QC Criteria

April 15, 2008

First Posted (ESTIMATE)

April 16, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 18, 2014

Last Update Submitted That Met QC Criteria

September 17, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-737

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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