Status:
COMPLETED
A Placebo-controlled Study With an Extension Examining the Safety and Efficacy of Alefacept in Psoriatic Arthritis
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Biogen
Conditions:
Psoriatic Arthritis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 +...
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 alefa...
Eligibility Criteria
Inclusion
- Psoriatic arthritis
- MTX treatment for 3 months prior to enrollment with continuing disease
- Normal T-cell count
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT00659412
Start Date
September 1 2003
End Date
March 1 2005
Last Update
September 18 2014
Active Locations (27)
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1
Birmingham, Alabama, United States, 35294
2
Wheaton, Maryland, United States, 20902
3
Lake Success, New York, United States, 11042
4
Rochester, New York, United States, 14642