A Phase 4 interventional study of Alefacept in Moderate to Severe Chronic Plaque Psoriasis, sponsored by Astellas Pharma Inc. Completed at 36 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-09-08.
Sponsored by Astellas Pharma Inc · Phase 4, Interventional, and Treatment
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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 114 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Alefacept
IM
Also known as: Amevive, ASP0485
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 study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Astellas Pharma Inc