Status:
COMPLETED
Open-label Study to Evaluate Safety of Multiple Courses of IM Alefacept During Treatment of Chronic Plaque Psoriasis
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Biogen
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
An extension study to evaluate safety and tolerability of up to 3 additional courses of IM alefacept in patients with chronic plaque psoriasis who have been previously treated with 1 or 2 courses of I...
Eligibility Criteria
Inclusion
- Must have received at least 8 injections in the C99-717 study and completed the final follow-up visit OR,
- Must have completed the C99-712 study and been in C99-717 interim visits at the time dosing in the C99-717 study was closed. A subject who completed C99-712 but did not participate in any part of C99-717, including interim visits, must have prior sponsor approval before admission into C-728
Exclusion
- Nursing mothers, pregnant women, and women planning to become pregnant while on study are to be excluded. Female patients who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study
- Clinically significant abnormal hematology values or history of an immunosuppressive disorder
- Serious local infection or systemic infection within 3 months prior to the first dose of alefacept
- A significant change in the subject's medical history from their previous alefacept study
- Any subject who initiated alternative systemic therapy, phototherapy, or disallowed therapy prior to visit 8 in study C99-712 or C99-717
- Current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy (participation in registry-type studies is allowed)
Key Trial Info
Start Date :
December 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2004
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT00692172
Start Date
December 1 2001
End Date
November 1 2004
Last Update
September 18 2014
Active Locations (43)
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1
Hot Springs, Arkansas, United States, 71913
2
Fresno, California, United States, 93710
3
La Jolla, California, United States, 92037
4
Washington D.C., District of Columbia, United States, 20010