Open-label Study to Evaluate Safety of Multiple Courses of IM Alefacept During Treatment of Chronic Plaque Psoriasis
NCT ID: NCT00692172
Last Updated: 2014-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
175 participants
INTERVENTIONAL
2001-12-31
2004-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Alefacept
intramuscular injection (IM)
Interventions
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Alefacept
intramuscular injection (IM)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Central Contact
Role: STUDY_DIRECTOR
Astellas Pharma US, Inc.
Locations
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Hot Springs, Arkansas, United States
Fresno, California, United States
La Jolla, California, United States
Washington D.C., District of Columbia, United States
Jacksonville, Florida, United States
Pinellas Park, Florida, United States
Newnan, Georgia, United States
Chicago, Illinois, United States
Kansas City, Kansas, United States
Clinton Township, Michigan, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Berlin, New Jersey, United States
Lake Oswego, Oregon, United States
Portland, Oregon, United States
Johnston, Rhode Island, United States
Goodlettsville, Tennessee, United States
Austin, Texas, United States
San Antonio, Texas, United States
Brussels, , Belgium
Edegem, , Belgium
Liège, , Belgium
Calgary, Alberta, Canada
Winnipeg, Manitoba, Canada
Moncton, New Brunswick, Canada
St. John's, Newfoundland and Labrador, Canada
London, Ontario, Canada
Waterloo, Ontario, Canada
Windsor, Ontario, Canada
Sainte-Foy, Quebec, Canada
Copenhagen, , Denmark
Besançon, , France
Brest, , France
Nice, , France
Paris, , France
Tours, , France
Bochum, , Germany
Dresden, , Germany
Munich, , Germany
Amsterdam, , Netherlands
Madrid, , Spain
Valencia, , Spain
Liverpool, , United Kingdom
Countries
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References
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Roberts JL, Ortonne JP, Tan JK, Jaracz E, Frankel E; Alefacept Clinical Study Group. The safety profile and sustained remission associated with response to multiple courses of intramuscular alefacept for treatment of chronic plaque psoriasis. J Am Acad Dermatol. 2010 Jun;62(6):968-78. doi: 10.1016/j.jaad.2009.07.032. Epub 2010 Apr 14.
Other Identifiers
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C-728
Identifier Type: -
Identifier Source: org_study_id
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