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

Sponsors and Collaborators:	Astellas Pharma Inc Biogen Idec
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00659412

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 II

MedlinePlus related topics: Psoriasis

Drug Information available for: Methotrexate Alefacept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
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

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
Course A1: Experimental	Drug: Alefacept Intramuscular Drug: Methotrexate Oral
Course A2: Placebo Comparator	Drug: Methotrexate Oral Drug: Placebo Intramuscular
Course B: Experimental Open-label extension	Drug: Alefacept Intramuscular 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

Rochester, New York, United States, 14642

Lake Success, New York, United States, 11042
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

Toronto, Ontario, Canada, M5T 2S8

Toronto, Ontario, Canada, K1N 5N1

London, Ontario, Canada, N6A 4V2

Newmarket, Ontario, Canada, L3Y 3R7
Canada, Quebec

Montreal, Quebec, Canada, H2L 1S6
Germany

Goettingen, Germany, D-37075

Berlin, Germany, D-13125

Frankfurt, Germany, D-60590
Poland

Elblag, Poland, 82-300

Warszawa, Poland, 02-637

Bialystok, Poland, 15-337

Kalisz, Poland, 62-800

Torun, Poland, 87-100

Krakow, Poland, 30-119
Russian Federation

Yaroslavl, Russian Federation, 150003

N. Novgorod, Russian Federation, 603600

Moscow, Russian Federation, 107076

St. Petersburg, Russian Federation, 194044

Moscow, Russian Federation, 115522

St Petersburg, Russian Federation, 190068

Sponsors and Collaborators

Astellas Pharma Inc

Biogen Idec

Investigators

Study Director:

Use Central Contact

Astellas Pharma US, Inc.

More Information

Additional Information:

Link to results disclosure This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by Astellas Pharma Inc:

Psoriatic arthritis
psoriasis
Alefacept

Study placed in the following topic categories:

Antimetabolites
Spinal Diseases
Alefacept
Immunologic Factors
Skin Diseases
Arthritis, Psoriatic
Joint Diseases
Spondylarthropathy
Folic Acid Antagonists
Immunosuppressive Agents

Bone Diseases
Folic Acid
Musculoskeletal Diseases
Psoriasis
Arthritis
Methotrexate
Antirheumatic Agents
Spondylarthritis
Skin Diseases, Papulosquamous
Spondylarthropathies

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Bone Diseases
Musculoskeletal Diseases
Psoriasis
Arthritis
Therapeutic Uses
Abortifacient Agents
Methotrexate
Spondylarthritis

Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Spondylarthropathies
Spinal Diseases
Alefacept
Skin Diseases
Arthritis, Psoriatic
Joint Diseases
Enzyme Inhibitors
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Antirheumatic Agents
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on May 07, 2009