Clinical trial NCT00692172: Open-label Study to Evaluate Safety of Multiple Courses of IM Alefacept During Treatment of Chronic Plaque Psoriasis
Official title: An Open-Label, Multi-center Study to Evaluate the Safety and Tolerability of Intramuscular Administration of Alefacept (LFA-3/IgG1 Fusion Protein) in Subjects With Chronic Plaque Psoriasis Who Have Completed Studies C99-717 or C99-712
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: psoriasis
alefacept
intramuscular
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Biogen
First posted: 2008-06-06
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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)

Primary outcomes:
measure: Assessment of safety including evaluation of incidence of adverse events, physical exams and laboratory monitoring
timeFrame: Throughout treatment course
Secondary outcomes:
measure: Proportion of subjects who achieved "Almost Clear" or "Clear" by Physicians' Global Assessment
timeFrame: Every 2 weeks throughout treamtent course
Other outcomes:
Locations:
city: Hot Springs
country: United States
state: Arkansas
city: Fresno
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Jacksonville
country: United States
state: Florida
city: Pinellas Park
country: United States
state: Florida
city: Newnan
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Kansas City
country: United States
state: Kansas
city: Clinton Township
country: United States
state: Michigan
city: St. Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Berlin
country: United States
state: New Jersey
city: Lake Oswego
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Johnston
country: United States
state: Rhode Island
city: Goodlettsville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Brussels
country: Belgium
city: Edegem
country: Belgium
city: Liege
country: Belgium
city: Calgary
country: Canada
state: Alberta
city: Winnipeg
country: Canada
state: Manitoba
city: Moncton
country: Canada
state: New Brunswick
city: St. John's
country: Canada
state: Newfoundland and Labrador
city: London
country: Canada
state: Ontario
city: Waterloo
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Sainte-Foy
country: Canada
state: Quebec
city: Copenhagen
country: Denmark
city: Besancon
country: France
city: Brest
country: France
city: Nice
country: France
city: Paris
country: France
city: Tours
country: France
city: Bochum
country: Germany
city: Dresden
country: Germany
city: Munich
country: Germany
city: Amsterdam
country: Netherlands
city: Madrid
country: Spain
city: Valencia
country: Spain
city: Liverpool
country: United Kingdom
Study officials:
affiliation: Astellas Pharma US, Inc.
name: Central Contact
role: STUDY_DIRECTOR
References:
citation: 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.