Psoriasis Clinical Trial
Open-label Study to Evaluate Safety of Multiple Courses of IM Alefacept During Treatment of Chronic Plaque Psoriasis
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 IM alefacept.
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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)
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There are 43 Locations for this study
Hot Springs Arkansas, 71913, United States
Fresno California, 93710, United States
La Jolla California, 92037, United States
Washington District of Columbia, 20010, United States
Jacksonville Florida, 32204, United States
Pinellas Park Florida, 33781, United States
Newnan Georgia, 30263, United States
Chicago Illinois, 60611, United States
Kansas City Kansas, 66160, United States
Clinton Township Michigan, 48038, United States
St. Louis Missouri, 63110, United States
Omaha Nebraska, 68131, United States
Berlin New Jersey, 08009, United States
Lake Oswego Oregon, 79035, United States
Portland Oregon, 97210, United States
Johnston Rhode Island, 02919, United States
Goodlettsville Tennessee, 37072, United States
Austin Texas, 78759, United States
San Antonio Texas, 78229, United States
Brussels , B-107, Belgium
Edegem , B-265, Belgium
Liege , 4000, Belgium
Calgary Alberta, T2S 3, Canada
Winnipeg Manitoba, R3C O, Canada
Moncton New Brunswick, E1C 8, Canada
St. John's Newfoundland and Labrador, A1B 4, Canada
London Ontario, N6A 3, Canada
Waterloo Ontario, N2J 1, Canada
Windsor Ontario, N8W 5, Canada
Sainte-Foy Quebec, G1V 4, Canada
Copenhagen , DK-24, Denmark
Besancon , 25030, France
Brest , 29279, France
Nice , 06202, France
Paris , 75475, France
Tours , 37044, France
Bochum , 44791, Germany
Dresden , 01307, Germany
Munich , 80337, Germany
Amsterdam , 1100 , Netherlands
Madrid , 28006, Spain
Valencia , 46014, Spain
Liverpool , L14 3, United Kingdom
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