Open-label Study to Evaluate Safety of Multiple Courses of IM Alefacept During Treatment of Chronic Plaque Psoriasis
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
1 other identifier
interventional
175
9 countries
43
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2001
Typical duration for phase_3
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 4, 2008
CompletedFirst Posted
Study publicly available on registry
June 6, 2008
CompletedSeptember 18, 2014
September 1, 2014
2.9 years
June 4, 2008
September 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of safety including evaluation of incidence of adverse events, physical exams and laboratory monitoring
Throughout treatment course
Secondary Outcomes (1)
Proportion of subjects who achieved "Almost Clear" or "Clear" by Physicians' Global Assessment
Every 2 weeks throughout treamtent course
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- Biogencollaborator
Study Sites (43)
Unknown Facility
Hot Springs, Arkansas, 71913, United States
Unknown Facility
Fresno, California, 93710, United States
Unknown Facility
La Jolla, California, 92037, United States
Unknown Facility
Washington D.C., District of Columbia, 20010, United States
Unknown Facility
Jacksonville, Florida, 32204, United States
Unknown Facility
Pinellas Park, Florida, 33781, United States
Unknown Facility
Newnan, Georgia, 30263, United States
Unknown Facility
Chicago, Illinois, 60611, United States
Unknown Facility
Kansas City, Kansas, 66160, United States
Unknown Facility
Clinton Township, Michigan, 48038, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
Omaha, Nebraska, 68131, United States
Unknown Facility
Berlin, New Jersey, 08009, United States
Unknown Facility
Lake Oswego, Oregon, 79035, United States
Unknown Facility
Portland, Oregon, 97210, United States
Unknown Facility
Johnston, Rhode Island, 02919, United States
Unknown Facility
Goodlettsville, Tennessee, 37072, United States
Unknown Facility
Austin, Texas, 78759, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Brussels, B-1070, Belgium
Unknown Facility
Edegem, B-2650, Belgium
Unknown Facility
Liège, 4000, Belgium
Unknown Facility
Calgary, Alberta, T2S 3B3, Canada
Unknown Facility
Winnipeg, Manitoba, R3C ON2, Canada
Unknown Facility
Moncton, New Brunswick, E1C 8X3, Canada
Unknown Facility
St. John's, Newfoundland and Labrador, A1B 4S8, Canada
Unknown Facility
London, Ontario, N6A 3H7, Canada
Unknown Facility
Waterloo, Ontario, N2J 1C, Canada
Unknown Facility
Windsor, Ontario, N8W 5L7, Canada
Unknown Facility
Sainte-Foy, Quebec, G1V 4X7, Canada
Unknown Facility
Copenhagen, DK-2400, Denmark
Unknown Facility
Besançon, 25030, France
Unknown Facility
Brest, 29279, France
Unknown Facility
Nice, 06202, France
Unknown Facility
Paris, 75475, France
Unknown Facility
Tours, 37044, France
Unknown Facility
Bochum, 44791, Germany
Unknown Facility
Dresden, 01307, Germany
Unknown Facility
Munich, 80337, Germany
Unknown Facility
Amsterdam, 1100 DE, Netherlands
Unknown Facility
Madrid, 28006, Spain
Unknown Facility
Valencia, 46014, Spain
Unknown Facility
Liverpool, L14 3LB, United Kingdom
Related Publications (1)
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.
PMID: 20392521BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Central Contact
Astellas Pharma US, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2008
First Posted
June 6, 2008
Study Start
December 1, 2001
Primary Completion
November 1, 2004
Study Completion
November 1, 2004
Last Updated
September 18, 2014
Record last verified: 2014-09