To evaluate the safety of treating subjects with up to 12 additional doses of alefacept.
Male and female subjects at least 18 years of age with moderate to severe plaque psoriasis treated with 12 weeks of alefacept 15 mg IM and who have not achieved the desired response. Dosing Groups: Subjects will receive either 4, 8, or 12 doses of alefacept 15 mg IM weekly immediately (within 14 days) following a standard 12-dose course of AMEVIVE® 15 mg IM. Determination of number of doses will be based on physician qualitative assessment at weeks 4 and 8.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
114
IM
To evaluate the safety of treating subjects with up to 12 additional doses of alefacept 15 mg IM following a standard 12-week course of AMEVIVE.
Time frame: 16 weeks, 20 weeks or 24 weeks
The proportion of subjects who achieve moderate improvement, significant improvement or clear, as assessed by the PQA score, at any time during the study,
Time frame: End of study
The cumulative change in PQA score from screening visit to best PQA score at any time in the study,
Time frame: End of study
Association of the total number of doses received with the best efficacy reached, as assessed by PQA score, at any time during the study,
Time frame: End of study
Time to re-treatment for subjects who achieve moderate improvement, significant improvement or clear, as assessed by the PQA score, at any time during the study,
Time frame: End of study
The cumulative change in SSA score from screening visit to best SSA score at any time in the study,
Time frame: End of study
Association of the total number of doses received with the best efficacy reached, as assessed by SSA score, at any time during the study, and
Time frame: End of study
Association of subject assessment of efficacy with physician assessment of efficacy as measured by the SSA score and PQA score respectively.
Time frame: End of study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Monheit Dermatology Associates
Birmingham, Alabama, United States
Bayshore Dermatology
Fairhope, Alabama, United States
Jayne Fortson
Anchorage, Alaska, United States
Bakersfield Dermatology & Skin Cancer Medical Group
Bakersfield, California, United States
Integrated Research Group
Riverside, California, United States
Robert Greenberg
San Ramon, California, United States
Front Dermatology
Denver, Colorado, United States
Skin and Cancer Associates
Tamarac, Florida, United States
Michael Scannon
Tampa, Florida, United States
Atlanta Derm, Vein & Research Center
Alpharetta, Georgia, United States
...and 26 more locations