Safety and Tolerability of Repeat Courses of IM Alefacept
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|ClinicalTrials.gov Identifier: NCT00233662|
Recruitment Status : Completed
First Posted : October 6, 2005
Last Update Posted : October 6, 2005
|Condition or disease||Intervention/treatment||Phase|
|Chronic Plaque Psoriasis||Drug: Alefacept||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||400 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of Repeat Courses of Intramuscular Administration of Alefacept (LFA-3/IgG1 Fusion Protein) in Patients With Chronic Plaque Psoriasis|
|Study Start Date :||December 2002|
|Study Completion Date :||June 2005|
- Incidence of infections, malignancies, serious adverse events, adverse events leading to discontinuation of study drug, dose withholding (due to infection or decreased T cells), and changes in lymphocyte counts over time.
- Patients who achieve a Physician Global Assessment (PGA) of "almost clear" or "clear" over time; the duration of the response to alefacept (the amount of time after alefacept treament before re-treatment with alefacept is necessary).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00233662
Show 46 Study Locations
|Study Director:||Barry Ticho, MD||Biogen|
|Principal Investigator:||Kenneth Gordon, MD||Loyola University|