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Sponsored by: |
EMD Serono |
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Information provided by: | EMD Serono |
ClinicalTrials.gov Identifier: | NCT00287118 |
Phase IIIb, open-label, multi-centre study to establish psoriasis control of moderate to severe plaque psoriasis with Raptiva therapy administered SC for 24 weeks.
Condition | Intervention | Phase |
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Candidates for Systemic Therapy for Psoriasis |
Drug: efalizumab=Raptiva |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Enrollment: | 189 |
Study Start Date: | October 2004 |
Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: efalizumab=Raptiva
Each patient will receive an initial conditioning dose of 0.7 mg/kg/week followed by 1.0 mg/kg/week study drug during the treatment period, 23 weeks. If four or more consecutive doses have been missed, dosing should resume with the conditioning dose of 0.7 mg/kg and then continue receiving 1mg/kg/week thereafter. Study drug will be administered by SC injection.
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Ages Eligible for Study: | 17 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany ( Mauro Placchi, PhD ) |
Study ID Numbers: | 25161, CONTROL I Study |
Study First Received: | February 2, 2006 |
Last Updated: | January 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00287118 |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
Skin Diseases Psoriasis Skin Diseases, Papulosquamous |