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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00659412
Recruitment Status : Completed
First Posted : April 16, 2008
Last Update Posted : September 18, 2014
Sponsor:
Collaborator:
Biogen
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Drug: Alefacept Drug: Methotrexate Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : September 2003
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Course A1 Drug: Alefacept
Intramuscular
Other Name: 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 Name: Amevive, ASP0485

Drug: Methotrexate
Oral




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00659412


Locations
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United States, Alabama
Birmingham, Alabama, United States, 35294
United States, Maryland
Wheaton, Maryland, United States, 20902
United States, New York
Lake Success, New York, United States, 11042
Rochester, New York, United States, 14642
United States, Washington
Seattle, Washington, United States, 98104
Canada, British Columbia
Victoria, British Columbia, Canada, V8V 3P9
Canada, Newfoundland and Labrador
St Johns, Newfoundland and Labrador, Canada, A1C 5B8
Canada, Ontario
London, Ontario, Canada, N6A 4V2
Newmarket, Ontario, Canada, L3Y 3R7
Toronto, Ontario, Canada, K1N 5N1
Toronto, Ontario, Canada, M5T 2S8
Canada, 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, 107076
Moscow, Russian Federation, 115522
N. Novgorod, Russian Federation, 603600
St Petersburg, Russian Federation, 190068
St. Petersburg, Russian Federation, 194044
Yaroslavl, Russian Federation, 150003
Sponsors and Collaborators
Astellas Pharma Inc
Biogen
Investigators
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Study Director: Use Central Contact Astellas Pharma US, Inc.

Additional Information:
Publications:
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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00659412     History of Changes
Other Study ID Numbers: C-737
First Posted: April 16, 2008    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014
Keywords provided by Astellas Pharma Inc:
Psoriatic arthritis
psoriasis
Alefacept
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Methotrexate
Alefacept
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors