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Studies used for retrospective and prospective application of SPC |
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| Study Number |
Study Title |
Number of Patients |
Application analysis of Good Safe Psoriasis Control (SPC) |
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| ACD 2058[14] |
"A Phase III, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter, Multidose Study to Evaluate the Efficacy and Safety of Subcutaneously Administered Anti-CD11a in Adults with Moderate to Severe Plaque Psoriasis" |
498 subjects •efalizumab 1 mg/kg – 162 •efalizumab 2 mg/kg – 166 •placebo – 170 |
Retrospective |
| ACD 2059[13] |
"A Phase III, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter, Multidose Study to Evaluate the Efficacy and Safety of Subcutaneously Administered Anti-CD11a in Adults with Moderate to Severe Plaque Psoriasis Who Are Candidates for Systemic Therapy" |
597 subjects •efalizumab 1 mg/kg – 232 •efalizumab 2 mg/kg – 243 •placebo – 122 |
Retrospective |
| ACD 2390[12] |
"A Phase IIIb, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of 1.0 mg/kg Subcutaneously Administered Efalizumab in Adults with Moderate to Severe Plaque Psoriasis" |
556 subjects •efalizumab 1 mg/kg – 369 •placebo – 187 |
Retrospective |
| IMP 24011[15] |
"A multicentre, randomised, double blind, placebo controlled phase III study of subcutaneously administered Raptiva in the treatment of patients with moderate to severe psoriasis" |
793 subjects •efalizumab 1 mg/kg – 529 •placebo – 264 •(526 high-need) |
Prospective |
Papp and Henninger BMC Dermatology 2006 6:8 doi:10.1186/1471-5945-6-8 |
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