A Multicentre, Open Label Phase IIIb/IV Study of Subcutaneously Administered Raptiva in the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis
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|ClinicalTrials.gov Identifier: NCT00287118|
Recruitment Status : Completed
First Posted : February 6, 2006
Results First Posted : April 3, 2018
Last Update Posted : April 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Candidates for Systemic Therapy for Psoriasis Psoriasis||Drug: Efalizumab||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||189 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicentre, Open Label Phase IIIb/IV Study of Subcutaneously Administered Raptiva in the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis|
|Actual Study Start Date :||October 27, 2004|
|Actual Primary Completion Date :||May 30, 2006|
|Actual Study Completion Date :||May 30, 2006|
Subjects will receive a conditioning dose of 0.7 milligram per kilogram (mg/kg) efalizumab subcutaneously on study Day 0 followed by 1.0 mg/kg efalizumab subcutaneously once a week for 23 weeks.
Other Name: Raptiva
- Percentage of Subjects With Physician's Global Assessment (PGA) Ratings of "Excellent" or "Cleared" at Week 24 [ Time Frame: Week 24 ]The PGA rating was used to assess the global response of all psoriatic lesions by comparing subject's present condition to baseline photographs or body diagrams. The response was classified as Cleared: 100% improvement of all clinical signs and symptoms compared to baseline; Excellent: 75% to 99% improvement of all signs and symptoms compared to baseline; Good: 50% to 74% improvement of signs and symptoms compared to baseline; Fair: 25% to 49% improvement of signs and symptoms compared to baseline; Slight: 1% to 24% improvement of signs and symptoms compared to baseline; Unchanged: Clinical signs and symptoms unchanged from baseline and Worse: Clinical signs and symptoms deteriorated from baseline.
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): NCT00287118
|Medical Information Switzerland|
|Study Director:||Medical Responsible||Merck KGaA, Darmstadt, Germany|