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

Completed · Phase 2 · Has a placebo group

Conditions studied: Psoriatic Arthritis

In brief

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.

Key facts

Study ID

NCT00659412

Run by

Astellas Pharma Inc

People needed

185

Starts

2003-09-01

Expected to finish

2005-03-01

Last updated by the study team

2014-09-18

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Psoriatic arthritis
• MTX treatment for 3 months prior to enrollment with continuing disease
• Normal T-cell count

You may not qualify if…

• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Wheaton, Maryland, United States
• Study site — Lake Success, New York, United States
• Study site — Rochester, New York, United States
• Study site — Seattle, Washington, United States
• Study site — Victoria, British Columbia, Canada
• Study site — St. John's, Newfoundland and Labrador, Canada
• Study site — London, Ontario, Canada
• Study site — Newmarket, Ontario, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Montreal, Quebec, Canada
• Study site — Berlin, Germany
• Study site — Frankfurt, Germany
• Study site — Göttingen, Germany
• Study site — Bialystok, Poland
• Study site — Elblag, Poland
• Study site — Kalisz, Poland
• Study site — Krakow, Poland
• Study site — Torun, Poland
• Study site — Warsaw, Poland
• Study site — Moscow, Russia
• Study site — Moscow, Russia
• Study site — Nizhny Novgorod, Russia
• Study site — Saint Petersburg, Russia

Full record on ClinicalTrials.gov

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