Psoriasis Clinical Trial

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

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.

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Full 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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Eligibility 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

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

185

Study ID:

NCT00659412

Recruitment Status:

Completed

Sponsor:

Astellas Pharma Inc

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There are 27 Locations for this study

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Birmingham Alabama, 35294, United States

Wheaton Maryland, 20902, United States

Lake Success New York, 11042, United States

Rochester New York, 14642, United States

Seattle Washington, 98104, United States

Victoria British Columbia, V8V 3, Canada

St Johns Newfoundland and Labrador, A1C 5, Canada

London Ontario, N6A 4, Canada

Newmarket Ontario, L3Y 3, Canada

Toronto Ontario, K1N 5, Canada

Toronto Ontario, M5T 2, Canada

Montreal Quebec, H2L 1, Canada

Berlin , D-131, Germany

Frankfurt , D-605, Germany

Goettingen , D-370, Germany

Bialystok , 15-33, Poland

Elblag , 82-30, Poland

Kalisz , 62-80, Poland

Krakow , 30-11, Poland

Torun , 87-10, Poland

Warszawa , 02-63, Poland

Moscow , 10707, Russian Federation

Moscow , 11552, Russian Federation

N. Novgorod , 60360, Russian Federation

St Petersburg , 19006, Russian Federation

St. Petersburg , 19404, Russian Federation

Yaroslavl , 15000, Russian Federation

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

185

Study ID:

NCT00659412

Recruitment Status:

Completed

Sponsor:


Astellas Pharma Inc

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