A Placebo-Controlled Study With an Extension Examining the Safety and Efficacy of Alefacept in Psoriatic Arthritis - Full Text View

Purpose

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	Intervention	Phase
Psoriatic Arthritis	Drug: Alefacept Drug: Methotrexate Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Genetics Home Reference related topics: psoriatic arthritis

MedlinePlus related topics: Psoriasis

Drug Information available for: Methotrexate Methotrexate sodium Alefacept

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]
Proportion of patients achieving a classification in the Physician's Global Assessment (PGA) of clear/almost clear [ Time Frame: Each scheduled efficacy visit ] [ Designated as safety issue: No ]
Sharp -VanDen Heijde Modified Score of Joint Damage (X-ray) [ Time Frame: Baseline, 24 Weeks and 48 Weeks ] [ Designated as safety issue: No ]

Enrollment:	185
Study Start Date:	September 2003
Study Completion Date:	March 2005
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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 transminases > 2X normal

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659412

Locations

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, M5T 2S8

Toronto, Ontario, Canada, K1N 5N1
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 Idec

Investigators

Study Director:

Use Central Contact

Astellas Pharma US, Inc.

More Information

No publications provided

Responsible Party:	Sr Manager Clinical Trial Registry, Astellas Pharma US, Inc.
ClinicalTrials.gov Identifier:	NCT00659412 History of Changes
Other Study ID Numbers:	C-737
Study First Received:	April 14, 2008
Last Updated:	August 21, 2008
Health Authority:	United States: Food and Drug Administration Canada: Health Canada Russia: Ministry of Health of the Russian Federation Poland: Ministry of Health

Keywords provided by Astellas Pharma Inc:

Psoriatic arthritis
psoriasis
Alefacept

Additional relevant MeSH terms:

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
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 16, 2013